Skin Cancer Pictures

[peanutbutter]

It gets more interesting when you realize this is not an isolated case.

 

This is from 2009:

 

 

Not long after that our Joe Cain started to use my oil on his head. He had a diagnosed spot of basil cell. It went away.

Ask Joe about it.

 

What is so wonderful about this case with Mike McShane is how very well it's documented.

[mrd]

You think I judging what your doing? I am judging how and how you present the evidence. I am qualified to understand the basics of the scientific method simply because I have taken some basic statistical based evidence courses in college. I am not qualified to set up a rigourous testing program. Just as I can tell certain things when my car is malfunctioning but I cannot engineer the broken parts. I still bother to read the manual to find out what I need to do and HOW to do it.

 

Have you spoken to anyone about how to set up an experiment and what evidence is needed to justify one's claims?

 

Here is an article for laymen. It just sets up idea of challenges involved.

 

 

 

 

Dr. Jeffrey H. ToneyDean of the College of Natural, Applied and Health Sciences, Kean University

Posted: October 27, 2010 08:11 AM

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Drug Discovery: The Challenge of Finding New Medicines

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Virtually everyone in the U.S. has relied on a prescription drug to alleviate an infection or a chronic disease. How is a drug discovered? How do we know that it is safe and effective? Behind every prescription drug is a story of scientific discovery, innumerable failures and extensive resources that led to eventual approval by the Food and Drug Administration (FDA).

 

The challenges of discovering new medicines sometimes brings to mind the Greek character Sisyphus whose punishment in Hades was to push a boulder up a hill almost to its zenith, only to find that his burden inexorably returns to the bottom. Weary Sisyphus must repeat the task for eternity.

 

 

 

"In the underworld Sisyphus was compelled to roll a big stone up a steep hill; but before it reached the top of the hill the stone always rolled down, and Sisyphus had to begin all over again (Odyssey, xi. 593)."

 

 

OK, perhaps this metaphor is overly dramatic, given that many new medicines are discovered regularly. Every now and then, that boulder does reach the tipping point representing a new discovery.

 

Approval of new drugs by the FDA has been declining, with 17 approvals in 2007, the lowest since 1983. Going from a "eureka" moment of discovering a candidate for a new drug to final approval by the FDA can take 10 to 15 years, costing on average $1.32 billion per drug.

 

Why does it take so long and require such a large investment? Because failure rates are high. That drug candidate discovered at the lab bench may have all of the desirable traits, including potency and specificity for the targeted disease, the right physical properties, a good safety profile in animal models such as mice or rats, but fails in the first phase of clinical trails using healthy volunteers.

 

Even those few candidate drugs that pass Phase I of the FDA-required clinical trails, showing safety when given to people, only about one in six succeed to final approval -- then the drug can be used as a prescription medicine.

 

The pharmaceutical industry has been fine tuning this process for many decades. How is it done and what is the "best" method?

 

 

Em and Ernie's Flickr photostream

 

Consider the proverbial haystack. Buried somewhere in this enormous stack are say five needles, similar but distinct. One of theses needles is golden. There are a number of ways that could help you find that prize needle.

 

First, the methodical. You, along with the help of a team, could remove one blade at a time from the haystack carefully placing it in a separate pile until one of you finds the five needles. The golden needle can then be easily found.

 

Second, the random hay roll. You could spread out the haystack evenly, then roll around the hay (I know) until one of the needles pokes you. Repeat the process until you find all five needles.

 

Third, use a detector. You could use a metal detector, scanning the entire haystack. This detector would have to be very sensitive to reveal the location of the tiny needles.

 

Fourth, use a smart detector. You could use a powerful magnet -- so strong that simply holding it near the haystack would pull the needles out of the haystack.

 

Each of these approaches has been used at one time or another. The current most popular methods are the "random hay roll" and the "smart detector" as ways to measure what could be the next new drug. The "smarter" the detector is, the more potent and effective the medicine will be, reducing chances of adverse side effects.

 

One of the biggest challenges in finding new medicines is in the battle of infectious diseases, because the disease-causing microbes or organisms are constantly evolving to survive and they mutate quickly. It's like trying to hit a moving target.

 

One such moving target is the parasite that causes malaria. Close to half of the world's population is, at one time or another, exposed to the parasite resulting in more than 800,000 deaths each year. Classical treatments such as chloroquine that were highly effective years ago have become less and less effective as the parasite develops resistance. With each wave of resistance to the medicine, a new medicine must be developed against which the organism inevitably becomes resistant.

 

(See here for an authoritative overview on malaria , which describes symptoms, treatment and prevention.)

 

A recent paper in the prestigious journal, Science reports the discovery of a new class of potential antimalarial compounds using a traditional approach for their "smart detector." (For News Focus click here, for a Perspectives, click here.) These scientists found their "golden needle" using a traditional "detector" -- the parasite itself. They carefully tested more than 12,000 chemicals, mostly from natural sources, and found 275 possible candidates that were capable of killing the parasite.

 

How could they find the best one? Most approved drugs share common physical properties that can guide these choices. Based on these criteria, only 17 candidates seemed promising. Only one from this group showed the most promise as an effective antimalarial treatment, belonging to a chemical class called spiroindolones. But the search doesn't stop there.

 

Hoping to fine tune how potent and specific the candidate drug could be, these scientists prepared about 200 related chemicals. From this new group, only one emerged with the desired properties. Most importantly, this potential drug is able to kill drug-resistant parasites in mice. So this compound is now poised to be tested in people, as the first Phase of clinical trials.

 

Could this spiroindolones be the next chloroquine that saved so many lives in the past? Remember that only about one in six candidates succeed, so there are still more mountains to be conquered.

 

 

 

Heres one on finding medically useful substances in nature.

 

eLab - Pharmacology

 

 

Turning to nature for new drugs

 

One of the best places to seek novel compounds for pharmaceutical drugs, alternative energy sources, and a host of industrial applications, is within natural systems that have evolved over millions of years. Scientists now realise that the precise molecular arrangements within natural pathways in organisms have been highly tuned for specific processes and provide both compounds that can be exploited directly and vital information over how to synthesise new products by mimicking biochemical processes. Dr.K.C. Nicolaou spoke with Scientist Live recently about searching for potential drugs within nature.

 

Can you explain why the "natural products pathway" holds so much potential in terms of drug discovery?

 

The "natural products pathway" to drug discovery, as you call it, has a proven record of success that speaks volumes for its future. Success stories like those of Aspirin®, penicillin, and Taxol® are but a few of its glorious past. In fact it has been estimated that over 60% of the drugs on the market today have their origin in some way or another from nature. If you consider this together with the fact that the molecules we have isolated from nature thus far represent only the tip of the iceberg of what is out there, then you can appreciate why this natural pathway holds so much potential in terms of drug discovery. The main reason why natural products are such good leads for drug discovery is that most of them come with important biological properties. They have been evolved to bind to biological receptors as part of the living world and, therefore, are likely to exert interesting biological activities that often have relevance to disease.

 

What are some particularly promising avenues of research and how are they being pursued?

 

Natural products have been particularly successful medicines against infectious disease and cancer. So there is a lot of research being carried out in pursuit of new anti-infectives and chemotherapeutic agents. Typically scientists look for such compounds in the forest (plants and trees), the soil (bacteria and fungi), and the ocean (marine creatures). Samples of various species - some more exotic than others - are collected from around the globe and brought back to the laboratory where they are carefully studied to reveal their molecular secrets. The new molecules so discovered are then tested by biologists for their possible therapeutic actions against disease. Current efforts are focused on new anticancer agents, new antibiotics particularly active against drug resistant bacteria, possible treatments of HIV/AIDS, and Alzheimer's disease.

 

 

 

In the press release associated with the ESF-COST conference, you made the differentiation between herbal medicine and your research. Can you elaborate on the differences? What is the difference between the products that result from the more chemical/scientific approach and herbal remedies that may contain similar chemicals?

 

Herbal medicine has been practiced for thousands of years beginning in the Middle East and the Orient. Such recipes often contain mixtures of compounds extracted from natural sources. They were developed without proper clinical trials, so their efficacy and safety have not been rigorously and systematically determined. In contrast, modern drug discovery and development follows strict scientific methods of investigation, usually of single compounds whose efficacy and safety profiles are systematically determined through toxicological and clinical trials. This process obviously ensures quality control and results in widely accepted medicines of proven value to the patient. So while herbal medicines may provide beneficial effects, they are not as well defined as modern medicine is. Natural products like the ones we are studying are part of the modern medicine cabinet. The latter are pure, single compounds and not cocktails of compounds as those found in herbal or folk medicines. One, however, should not underestimate the value of folk medicines, for they provide interesting clues that may lead scientists to the magic ingredient which can then be developed as a pure substance into a modern and highly effective drug.

 

What is your particular area of expertise? Can you give a overview of what you are exploring and its possibilities?

 

My research group, like many others around the world, is involved in the chemical synthesis of complex and biologically active natural products, molecules discovered by other scientists in the forest, the soil, or the ocean. There are several reasons why one wishes to synthesise such molecules. One good reason is the fact that these molecules are often scarce and cannot be harvested from their natural sources in large enough quantities to allow their thorough biological investigation, so chemical synthesis becomes the only available means to produce them. In cases where these molecules are complex in terms of their molecular structures, the laboratory synthesis is far from trivial. The synthetic chemist has to develop ingenious and multi-step synthetic strategies to reach them, through campaigns that may, sometimes, take years to develop. But once developed, such processes can provide large quantities of these precious molecules for further biological studies in order to determine their potential as medicines. Most importantly, these technologies allow the synthetic chemists to go beyond nature and synthesise designed versions of the natural molecules that can then be tested in search of superior pharmacological properties. Such improved molecules may then lead to drugs with higher potencies and less side-effects from the ones nature provides. Following this approach, which obviously takes its lessons from nature, we are currently following leads for new antibiotics and anticancer drugs.

 

As an example of our anticancer research, I can mention the epothilones, a class of naturally occurring molecules originally discovered from a species of bacteria that were found in dirt collected from the banks of the Zambezi River in southern Africa. Following our successful campaign to construct them in the laboratory, we proceeded to design and synthesize numerous analogs of the natural molecules, eventually discovering more powerful anti-cancer agents. Some of these compounds are now in further development. A similar story is currently developing in our laboratory in the area of antibacterial agents effective against drug resistant bacteria. In this case too, the lead compound came from nature. Coined platensimycin, this natural product was first reported by Merck scientists in 2006 and demonstrated powerful activities against all drug-resistant bacteria tested, an impressive and exciting prospect considering the increasing menace posed by such bacterial strains to humanity. Our group was the first, among over a dozen groups by now, to synthesize platensimycin. The search is now on for a superior molecular version of this natural antibiotic that will, hopefully, surpass it in terms of potency and pharmacological properties as a potential drug against these frightening pathogens. Next, who knows, we may get involved in the area of Alzheimer's disease which is a major challenge for science and medicine, made even more acute as the ageing population increases around the world. Indeed, nature may hold some secrets in this regard too, for example within the extracts of "Ginkgo Biloba," a herbal medicine that some believe has beneficial effects on memory and cognitive function.

 

Are there any limitations to the "natural pathway" approach to discovering new compounds?

 

Of course, despite the success and future promise of the "natural pathway" to drug discovery, modern medicine has demonstrated an alternative and complementary approach to drug discovery. This approach, which also relies on chemical synthesis, involves man-made molecules. These molecules are not found in nature, but are rather designed and synthesised by chemists in the laboratory. In this approach, high-throughput biological screening of large numbers of such compounds (often referred to as compound libraries), a few lead compounds are discovered, which are then fine-tuned by chemists in order to optimise their pharmacological properties, leading to drug candidates for further development. The two approaches are complementary to each other and are both considered by many as productive and worthwhile avenues to drug discovery. Although more tedious and expensive, the "natural pathway" may provide larger dividends in terms of gaining new and fundamental knowledge in chemistry and biology, and may result in new paradigm and block-buster drugs as demonstrated recently with FK506 and rapamycin (immunosuppressive drugs used in transplantations), Taxol® (anticancer drug), and the statins (cholesterol lowering drugs).

 

At this point, what is the next step for this area of research?

 

Given the relatively high cost and the fact that natural products based drug discovery requires considerable patience, and because of the seemingly attractive nature of other approaches to drug discovery such as combinatorial chemistry and biologics, pharmaceutical companies and funding agencies have, in recent years, decreased their investments in the former area of research. Thankfully, there are signs that this trend is now changing, perhaps partly because of the apparent scarcity of new drug approvals in recent years and the disappointing current drug development pipelines. What is needed, in my opinion, in this area of research is to invest in it more time and effort so as to allow exploration of the incredible biodiversity that exists on our planet. Our forests and our oceans are still, to a large extent, unexplored despite the secrets they are certain to hold. Such explorations will yield, in turn, an amazing molecular diversity that will reveal new biology and inspire new chemistry and new pathways to much needed cures. Millions of species are in danger of extinction and they will take with them their molecular secrets. It will be a shame to loose them both, for besides the damage that such catastrophe will bring to nature, this extinction may also shut the "natural pathway" to discovery, denying humanity, perhaps forever, the knowledge required for the next generation of cures.

 

(More about stories of drugs discovered from nature can be found in a recent book by K.C. Nicolaou and Tamsyn Montagnon titled Molecules that Changed the World (2008, Wiley-VCH).)

 

(Reporting by Marc Landas)

 

 

 

There are hundreds and hundreds of articles.

 

Here is something lifted from Wikipedia. Certainly Wikipedia is not perfect but this should give us a general idea of what goes into testing.

Clinical trial

From Wikipedia, the free encyclopedia

 

This article may be too long to read and navigate comfortably. Please consider splitting content into sub-articles and using this article for a summary of the key points of the subject. (October 2010)

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization or a clinical trials unit in the academic sector.

Contents [hide]

1 Overview

2 History

3 Types

4 Design

4.1 Active comparator studies

4.2 Clinical trial protocol

4.3 Design features

4.3.1 Informed consent

4.3.2 Statistical power

4.4 Placebo groups

5 Phases

5.1 Pre-clinical studies

5.2 Phase 0

5.3 Phase I

5.4 Phase II

5.5 Phase III

5.6 Phase IV

5.7 Phase V

6 Length

7 Administration

8 Ethical conduct

9 Safety

9.1 Sponsor

9.2 Local site investigators

9.3 IRBs

9.4 Regulatory agencies

10 Economics

10.1 Sponsor

10.2 Investigators

10.3 Patients

11 Participating in a clinical trial

11.1 Locating trials

11.2 Steps for volunteers

12 Information technology

13 Controversy

14 References

15 External links

[edit]Overview

 

Clinical trials often involve patients with specific health conditions who then benefit from receiving otherwise unavailable treatments. In early phases, participants are healthy volunteers who receive financial incentives for their inconvenience. During dosing periods, study subjects typically remain on site at the unit for durations of anything from 1 to 30 nights, occasionally longer, although this is not always required.

In planning a clinical trial, the sponsor or investigator first identifies the medication or device to be tested. Usually, one or more pilot experiments are conducted to gain insights for design of the clinical trial to follow. In medical jargon, effectiveness is how well a treatment works in practice and efficacy is how well it works in a clinical trial. In the U.S., the elderly comprise only 14% of the population but they consume over one-third of drugs.[1] Despite this, they are often excluded from trials because their more frequent health issues and drug use produce unreliable data. Women, children, and people with unrelated medical conditions are also frequently excluded.[2]

In coordination with a panel of expert investigators (usually physicians well known for their publications and clinical experience), the sponsor decides what to compare the new agent with (one or more existing treatments or a placebo), and what kind of patients might benefit from the medication or device. If the sponsor cannot obtain enough patients with this specific disease or condition at one location, then investigators at other locations who can obtain the same kind of patients to receive the treatment would be recruited into the study.

During the clinical trial, the investigators: recruit patients with the predetermined characteristics, administer the treatment(s), and collect data on the patients' health for a defined time period. These patients are volunteers and they are not paid for participating in clinical trials. These data include measurements like vital signs, concentration of the study drug in the blood, and whether the patient's health improves or not. The researchers send the data to the trial sponsor who then analyzes the pooled data using statistical tests.

Some examples of what a clinical trial may be designed to do:

Assess the safety and effectiveness of a new medication or device on a specific kind of patient (e.g., patients who have been diagnosed with Alzheimer's disease)

Assess the safety and effectiveness of a different dose of a medication than is commonly used (e.g., 10 mg dose instead of 5 mg dose)

Assess the safety and effectiveness of an already marketed medication or device for a new indication, i.e. a disease for which the drug is not specifically approved

Assess whether the new medication or device is more effective for the patient's condition than the already used, standard medication or device ("the gold standard" or "standard therapy")

Compare the effectiveness in patients with a specific disease of two or more already approved or common interventions for that disease (e.g., Device A vs. Device B, Therapy A vs. Therapy B)

Note that while most clinical trials compare two medications or devices, some trials compare three or four medications, doses of medications, or devices against each other.

Except for very small trials limited to a single location, the clinical trial design and objectives are written into a document called a clinical trial protocol. The protocol is the 'operating manual' for the clinical trial and ensures that researchers in different locations all perform the trial in the same way on patients with the same characteristics. (This uniformity is designed to allow the data to be pooled.) A protocol is always used in multicenter trials.

Because the clinical trial is designed to test hypotheses and rigorously monitor and assess what happens, clinical trials can be seen as the application of the scientific method, and specifically the experimental step, to understanding human or animal biology.

The most commonly performed clinical trials evaluate new drugs, medical devices (like a new catheter), biologics, psychological therapies, or other interventions. Clinical trials may be required before the national regulatory authority[3] approves marketing of the drug or device, or a new dose of the drug, for use on patients.

[edit]History

 

The history of clinical trials before 1750 is brief.[4][5]

The concepts behind clinical trials, however, are ancient. The Book of Daniel verses 12 through 15, for instance, describes a planned experiment with both baseline and follow-up observations of two groups who either partook of, or did not partake of, "the King's meat" over a trial period of ten days. Persian physician and philosopher, Avicenna, gave such inquiries a more formal structure.[6] In The Canon of Medicine in 1025 AD, he laid down rules for the experimental use and testing of drugs and wrote a precise guide for practical experimentation in the process of discovering and proving the effectiveness of medical drugs and substances.[7] He laid out the following rules and principles for testing the effectiveness of new drugs and medications:[8][9][verification needed]

The drug must be free from any extraneous accidental quality.

It must be used on a simple, not a composite, disease.

The drug must be tested with two contrary types of diseases, because sometimes a drug cures one disease by its essential qualities and another by its accidental ones.

The quality of the drug must correspond to the strength of the disease. For example, there are some drugs whose heat is less than the coldness of certain diseases, so that they would have no effect on them.

The time of action must be observed, so that essence and accident are not confused.

The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect.

The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man.

One of the most famous clinical trials was James Lind's demonstration in 1747 that citrus fruits cure scurvy.[10] He compared the effects of various different acidic substances, ranging from vinegar to cider, on groups of afflicted sailors, and found that the group who were given oranges and lemons had largely recovered from scurvy after 6 days.

Frederick Akbar Mahomed (d. 1884), who worked at Guy's Hospital in London,[11] made substantial contributions to the process of clinical trials during his detailed clinical studies, where "he separated chronic nephritis with secondary hypertension from what we now term essential hypertension." He also founded "the Collective Investigation Record for the British Medical Association; this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials."[12]

[edit]Types

 

One way of classifying clinical trials is by the way the researchers behave.

In an observational study, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study. An example is the Nurses' Health Study.

In an interventional study, the investigators give the research subjects a particular medicine or other intervention. Usually, they compare the treated subjects to subjects who receive no treatment or standard treatment. Then the researchers measure how the subjects' health changes.

Another way of classifying trials is by their purpose. The U.S. National Institutes of Health (NIH) organizes trials into five (5) different types:[13]

Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Screening trials: test the best way to detect certain diseases or health conditions.

Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.

Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).

Compassionate use trials or expanded access: provide partially tested, unapproved therapeutics prior to a small number of patients that have no other realistic options. Usually, this involves a disease for which no effective therapy exists, or a patient that has already attempted and failed all other standard treatments and whose health is so poor that he does not qualify for participation in randomized clinical trials.[14] Usually, case by case approval must be granted by both the FDA and the pharmaceutical company for such exceptions.

[edit]Design

 

Main article: Clinical study design

A fundamental distinction in evidence-based medicine is between observational studies and randomized controlled trials. Types of observational studies in epidemiology such as the cohort study and the case-control study provide less compelling evidence than the randomized controlled trial. In observational studies, the investigators only observe associations (correlations) between the treatments experienced by participants and their health status or diseases.

A randomized controlled trial is the study design that can provide the most compelling evidence that the study treatment causes the expected effect on human health.

Currently, some Phase II and most Phase III drug trials are designed as randomized, double blind, and placebo-controlled.

Randomized: Each study subject is randomly assigned to receive either the study treatment or a placebo.

Blind: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject. This 'blinding' is to prevent biases, since if a physician knew which patient was getting the study treatment and which patient was getting the placebo, he/she might be tempted to give the (presumably helpful) study drug to a patient who could more easily benefit from it. In addition, a physician might give extra care to only the patients who receive the placebos to compensate for their ineffectiveness. A form of double-blind study called a "double-dummy" design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.

Placebo-controlled: The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment.

Although the term "clinical trials" is most commonly associated with the large, randomized studies typical of Phase III, many clinical trials are small. They may be "sponsored" by single physicians or a small group of physicians, and are designed to test simple questions. In the field of rare diseases sometimes the number of patients might be the limiting factor for a clinical trial. Other clinical trials require large numbers of participants (who may be followed over long periods of time), and the trial sponsor is a private company, a government health agency, or an academic research body such as a university.

[edit]Active comparator studies

Of note, during the last ten years or so it has become a common practice to conduct "active comparator" studies (also known as "active control" trials). In other words, when a treatment exists that is clearly better than doing nothing for the subject (i.e. giving them the placebo), the alternate treatment would be a standard-of-care therapy. The study would compare the 'test' treatment to standard-of-care therapy.

A growing trend in the pharmacology field involves the use of third-party contractors to obtain the required comparator compounds. Such third parties provide expertise in the logistics of obtaining, storing, and shipping the comparators. As an advantage to the manufacturer of the comparator compounds, a well-established comparator sourcing agency can alleviate the problem of parallel importing (importing a patented compound for sale in a country outside the patenting agency's sphere of influence).[citation needed]

[edit]Clinical trial protocol

Main article: Clinical trial protocol

A clinical trial protocol is a document used to gain confirmation of the trial design by a panel of experts and adherence by all study investigators, even if conducted in various countries.

The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations, and organization of the planned trial. Details of the trial are also provided in other documents referenced in the protocol such as an Investigator's Brochure.

The protocol contains a precise study plan for executing the clinical trial, not only to assure safety and health of the trial subjects, but also to provide an exact template for trial conduct by investigators at multiple locations (in a "multicenter" trial) to perform the study in exactly the same way. This harmonization allows data to be combined collectively as though all investigators (referred to as "sites") were working closely together. The protocol also gives the study administrators (often a contract research organization or CRO) as well as the site team of physicians, nurses and clinic administrators a common reference document for site responsibilities during the trial.

The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan has been standardized to follow Good Clinical Practice guidance[15] issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).[16] Regulatory authorities in Canada and Australia also follow ICH guidelines. Some journals, e.g. Trials, encourage trialists to publish their protocols in the journal.

[edit]Design features

[edit]Informed consent

An essential component of initiating a clinical trial is to recruit study subjects following procedures using a signed document called "informed consent".[17]

Informed consent is a legally-defined process of a person being told about key facts involved in a clinical trial before deciding whether or not to participate. To fully describe participation to a candidate subject, the doctors and nurses involved in the trial explain the details of the study using terms the person will understand. Foreign language translation is provided if the participant's native language is not the same as the study protocol.

The research team provides an informed consent document that includes trial details, such as its purpose, duration, required procedures, risks, potential benefits and key contacts. The participant then decides whether or not to sign the document in agreement. Informed consent is not an immutable contract, as the participant can withdraw at any time without penalty.

[edit]Statistical power

The number of patients enrolled in a study has a large bearing on the ability of the study to reliably detect the size of the effect of the study intervention. This is described as the "power" of the trial. The larger the sample size or number of participants in the trial, the greater the statistical power.

However, in designing a clinical trial, this consideration must be balanced with the fact that more patients make for a more expensive trial. The power of a trial is not a single, unique value; it estimates the ability of a trial to detect a difference of a particular size (or larger) between the treated (tested drug/device) and control (placebo or standard treatment) groups. By example, a trial of a lipid-lowering drug versus placebo with 100 patients in each group might have a power of .90 to detect a difference between patients receiving study drug and patients receiving placebo of 10 mg/dL or more, but only have a power of .70 to detect a difference of 5 mg/dL.

[edit]Placebo groups

Main article: Placebo-controlled studies

Merely giving a treatment can have nonspecific effects, and these are controlled for by the inclusion of a placebo group. Subjects in the treatment and placebo groups are assigned randomly and blinded as to which group they belong. Since researchers can behave differently to subjects given treatments or placebos, trials are also doubled-blinded so that the researchers do not know to which group a subject is assigned.

Assigning a person to a placebo group can pose an ethical problem if it violates his or her right to receive the best available treatment. The Declaration of Helsinki provides guidelines on this issue.

[edit]Phases

 

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.

[edit]Pre-clinical studies

It involves in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug.

[edit]Phase 0

Phase 0 is a recent designation for exploratory, first-in-human trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies.[18] Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[19]

A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

Questions have been raised by experts about whether Phase 0 trials are useful, ethically acceptable, feasible, speed up the drug development process or save money, and whether there is room for improvement.[20]

[edit]Phase I

Phase I trials are the first stage of testing in human subjects. Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. "The reason for conducting the trial is to discover the point at which a compound is too poisonous to administer."[21] Volunteers are paid an inconvenience fee for their time spent in the volunteer centre. Pay ranges from a small amount of money for a short period of residence, to a larger amount of up to approx $6000 depending on length of participation.

There are different kinds of Phase I trial:

SAD

Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects, and the pharmacokinetic data is roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the Maximum tolerated dose (MTD)).

MAD

Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level.

Food effect

A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug while fasted, and after being fed.

[edit]Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

Phase II studies are sometimes divided into Phase IIA and Phase IIB.

Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).

Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Trial design

Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.

[edit]Phase III

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorised as "Phase IIIB studies."[22][23]

While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), or the EMA (European Union), for example.

Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[3] in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug.

Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.[24]

[edit]Phase IV

Phase IV trial is also known as Postmarketing surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

[edit]Phase V

Phase V is a growing term used in the literature of translational research to refer to comparative effectiveness research and community-based research; it is used to signify the integration of a new clinical treatment into widespread public health practice. [1]

[edit]Length

 

Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever undergoing clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial.[citation needed] For example, a new cancer drug has, on average, 6 years of research behind it before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is the time it takes to complete clinical trials themselves. On average, about 8 years pass from the time a cancer drug enters clinical trials until it receives approval from regulatory agencies for sale to the public. Drugs for other diseases have similar timelines.

Some reasons a clinical trial might last several years:

For chronic conditions like cancer, it takes months, if not years, to see if a cancer treatment has an effect on a patient.

For drugs that are not expected to have a strong effect (meaning a large number of patients must be recruited to observe any effect), recruiting enough patients to test the drug's effectiveness (i.e., getting statistical power) can take several years.

Only certain people who have the target disease condition are eligible to take part in each clinical trial. Researchers who treat these particular patients must participate in the trial. Then they must identify the desirable patients and obtain consent from them or their families to take part in the trial.

The biggest barrier to completing studies is the shortage of people who take part. All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit (because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo). In the case of cancer patients, fewer than 5% of adults with cancer will participate in drug trials. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), about 400 cancer medicines were being tested in clinical trials in 2005. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.[25]

For clinical trials involving a seasonal indication (such as airborne allergies, Seasonal Affective Disorder, influenza, and others), the study can only be done during a limited part of the year (such as Spring for pollen allergies), when the drug can be tested. This can be an additional complication on the length of the study, yet proper planning and the use of trial sites in the southern as well as northern hemispheres allows for year-round trials can reduce the length of the studies.[26][27]

Clinical trials that do not involve a new drug usually have a much shorter duration. (Exceptions are epidemiological studies like the Nurses' Health Study.)

[edit]Administration

 

Clinical trials designed by a local investigator and (in the U.S.) federally funded clinical trials are almost always administered by the researcher who designed the study and applied for the grant. Small-scale device studies may be administered by the sponsoring company. Phase III and Phase IV clinical trials of new drugs are usually administered by a contract research organization (CRO) hired by the sponsoring company. (The sponsor provides the drug and medical oversight.) A CRO is a company that is contracted to perform all the administrative work on a clinical trial. It recruits participating researchers, trains them, provides them with supplies, coordinates study administration and data collection, sets up meetings, monitors the sites for compliance with the clinical protocol, and ensures that the sponsor receives 'clean' data from every site. Recently, site management organizations have also been hired to coordinate with the CRO to ensure rapid IRB/IEC approval and faster site initiation and patient recruitment.

At a participating site, one or more research assistants (often nurses) do most of the work in conducting the clinical trial. The research assistant's job can include some or all of the following: providing the local Institutional Review Board (IRB) with the documentation necessary to obtain its permission to conduct the study, assisting with study start-up, identifying eligible patients, obtaining consent from them or their families, administering study treatment(s), collecting and statistically analyzing data, maintaining and updating data files during followup, and communicating with the IRB, as well as the sponsor and CRO.

[edit]Ethical conduct

 

Clinical trials are closely supervised by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. The local ethics committee has discretion on how it will supervise noninterventional studies (observational studies or those using already collected data). In the U.S., this body is called the Institutional Review Board (IRB). Most IRBs are located at the local investigator's hospital or institution, but some sponsors allow the use of a central (independent/for profit) IRB for investigators who work at smaller institutions.

To be ethical, researchers must obtain the full and informed consent of participating human subjects. (One of the IRB's main functions is ensuring that potential patients are adequately informed about the clinical trial.) If the patient is unable to consent for him/herself, researchers can seek consent from the patient's legally authorized representative. In California, the state has prioritized the individuals who can serve as the legally authorized representative.[28]

In some U.S. locations, the local IRB must certify researchers and their staff before they can conduct clinical trials. They must understand the federal patient privacy (HIPAA) law and good clinical practice. International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH GCP) is a set of standards used internationally for the conduct of clinical trials. The guidelines aim to ensure that the "rights, safety and well being of trial subjects are protected".

The notion of informed consent of participating human subjects exists in many countries all over the world, but its precise definition may still vary.

Informed consent is clearly a necessary condition for ethical conduct but does not ensure ethical conduct. The final objective is to serve the community of patients or future patients in a best-possible and most responsible way. However, it may be hard to turn this objective into a well-defined quantified objective function. In some cases this can be done, however, as for instance for questions of when to stop sequential treatments (see Odds algorithm), and then quantified methods may play an important role.

Additional ethical concerns are present when conducting clinical trials on children (pediatrics).

[edit]Safety

 

Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study, and (in some cases, if the study involves a marketable drug or device) the regulatory agency for the country where the drug or device will be sold.

For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases the male partners of these women are also excluded or required to take birth control measures.

[edit]Sponsor

Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment(s) with already approved medical treatments. This allows the local investigators to make an informed judgment on whether to participate in the study or not.

The sponsor is responsible for monitoring the results of the study as they come in from the various sites, as the trial proceeds. In larger clinical trials, a sponsor will use the services of a Data Monitoring Committee (DMC, known in the U.S. as a Data Safety Monitoring Board). This is an independent group of clinicians and statisticians. The DMC meets periodically to review the unblinded data that the sponsor has received so far. The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious adverse events.

The sponsor is responsible for collecting adverse event reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment. This is an area where sponsors can slant their judgment to favor the study treatment.

The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language. FDA regulations and ICH guidelines both require that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative." If the participant's native language is not English, the sponsor must translate the informed consent into the language of the participant.[29]

[edit]Local site investigators

A physician's first duty is to his/her patients, and if a physician investigator believes that the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects, and can act unethically in order to obtain and maintain their participation.

The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study.

The local investigator or his/her study staff are responsible for ensuring that potential subjects in the study understand the risks and potential benefits of participating in the study; in other words, that they (or their legally authorized representatives) give truly informed consent.

The local investigators are responsible for reviewing all adverse event reports sent by the sponsor. (These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments). The local investigators are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study-treatment-related adverse events.

When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected.

The local investigator is responsible for being truthful to the local IRB in all communications relating to the study.

[edit]IRBs

Approval by an IRB, or ethics board, is necessary before all but the most informal medical research can begin.

In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial. However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent(s), the data collection forms, and supporting documentation to the local IRB. Universities and most hospitals have in-house IRBs. Other researchers (such as in walk-in clinics) use independent IRBs.

The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study, before it allows the researcher to begin the study. It may require changes in study procedures or in the explanations given to the patient. A required yearly "continuing review" report from the investigator updates the IRB on the progress of the study and any new safety information related to the study.

[edit]Regulatory agencies

If a clinical trial concerns a new regulated drug or medical device (or an existing drug for a new purpose), the appropriate regulatory agency for each country where the sponsor wishes to sell the drug or device is supposed to review all study data before allowing the drug/device to proceed to the next phase, or to be marketed. However, if the sponsor withholds negative data, or misrepresents data it has acquired from clinical trials, the regulatory agency may make the wrong decision.

In the U.S., the FDA can audit the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures. This audit may be random, or for cause (because the investigator is suspected of fraudulent data). Avoiding an audit is an incentive for investigators to follow study procedures.

Different countries have different regulatory requirements and enforcement abilities. "An estimated 40 percent of all clinical trials now take place in Asia, Eastern Europe, central and south America. "There is no compulsory registration system for clinical trials in these countries and many do not follow European directives in their operations", says Dr. Jacob Sijtsma of the Netherlands-based WEMOS, an advocacy health organisation tracking clinical trials in developing countries." [30]

Beginning in the 1980s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization named after 1990 as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [31] Currently, most clinical trial programs follow ICH guidelines, aimed at "ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness."[32]

[edit]Economics

 

[edit]Sponsor

The cost of a study depends on many factors, especially the number of sites that are conducting the study, the number of patients required, and whether the study treatment is already approved for medical use. Clinical trials follow a standardized process.

The costs to a pharmaceutical company of administering a Phase III or IV clinical trial may include, among others:

manufacturing the drug(s)/device(s) tested

staff salaries for the designers and administrators of the trial

payments to the contract research organization, the site management organization (if used) and any outside consultants

payments to local researchers (and their staffs) for their time and effort in recruiting patients and collecting data for the sponsor

study materials and shipping

communication with the local researchers, including onsite monitoring by the CRO before and (in some cases) multiple times during the study

one or more investigator training meetings

costs incurred by the local researchers such as pharmacy fees, IRB fees and postage.

any payments to patients enrolled in the trial (all payments are strictly overseen by the IRBs to ensure that patients do not feel coerced to take part in the trial by overly attractive payments)

These costs are incurred over several years.

In the U.S. there is a 50% tax credit for sponsors of certain clinical trials.[33]

National health agencies such as the U.S. National Institutes of Health offer grants to investigators who design clinical trials that attempt to answer research questions that interest the agency. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites. These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them.

Clinical trials are traditionally expensive and difficult to undertake. Using internet resources can, in some cases, reduce the economic burden.[34]

[edit]Investigators

Many clinical trials do not involve any money. However, when the sponsor is a private company or a national health agency, investigators are almost always paid to participate. These amounts can be small, just covering a partial salary for research assistants and the cost of any supplies (usually the case with national health agency studies), or be substantial and include 'overhead' that allows the investigator to pay the research staff during times in between clinical trials.

[edit]Patients

In Phase I drug trials, participants are paid because they give up their time (sometimes away from their homes) and are exposed to unknown risks, without the expectation of any benefit. In most other trials, however, patients are not paid, in order to ensure that their motivation for participating is the hope of getting better or contributing to medical knowledge, without their judgment being skewed by financial considerations. However, they are often given small payments for study-related expenses like travel or as compensation for their time in providing follow-up information about their health after they are discharged from medical care.

[edit]Participating in a clinical trial

 

 

 

Newspaper advertisements seeking patients and healthy volunteers to participate in clinical trials.

Phase 0 and Phase I drug trials seek healthy volunteers. Most other clinical trials seek patients who have a specific disease or medical condition.

[edit]Locating trials

Depending on the kind of participants required, sponsors of clinical trials use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go (such as doctor's offices), and personal recruitment of patients by investigators.

Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials. For example, people with Parkinson's disease can use PDtrials to find up-to-date information on Parkinson's disease trials currently enrolling participants in the U.S. and Canada, and search for specific Parkinson's clinical trials using criteria such as location, trial type, and symptom.[35] Other disease-specific services exist for volunteers to find trials related to their condition.[36] Volunteers may search directly on ClinicalTrials.gov to locate trials using a registry run by the U.S. National Institutes of Health and National Library of Medicine.

However, many clinical trials will not accept participants who contact them directly to volunteer as it is believed this may bias the characteristics of the population being studied. Such trials typically recruit via networks of medical professionals who ask their individual patients to consider enrollment.[citation needed]

[edit]Steps for volunteers

Before participating in a clinical trial, interested volunteers should speak with their doctors, family members, and others who have participated in trials in the past. After locating a trial, volunteers will often have the opportunity to speak or e-mail the clinical trial coordinator for more information and to answer any questions. After receiving consent from their doctors, volunteers then arrange an appointment for a screening visit with the trial coordinator.[37]

All volunteers being considered for a trial are required to undertake a medical screen. There are different requirements for different trials, but typically volunteers will have the following tests:[38]

Measurement of the electrical activity of the heart (ECG)

Measurement of blood pressure, heart rate and temperature

Blood sampling

Urine sampling

Weight and height measurement

Drugs abuse testing

Pregnancy testing (females only)

[edit]Information technology

 

The last decade has seen a proliferation of information technology use in the planning and conduct of clinical trials. Clinical trial management systems (CTMS) are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites. Web-based electronic data capture (EDC) and clinical data management systems (CDMS) are used in a majority of clinical trials[39] to collect case report data from sites, manage its quality and prepare it for analysis. Interactive voice response systems (IVRS) are used by sites to register the enrollment of patients using a phone and to allocate patients to a particular treatment arm (although phones are being increasingly replaced with web-based (IWRS) tools which are sometimes part of the EDC system). Patient-reported outcome measures are being increasingly collected using hand-held, sometimes wireless ePRO (or eDiary) devices. Statistical software is used to analyze the collected data and prepare it for regulatory submission. Access to many of these applications are increasingly aggregated in web-based clinical trial portals.

[edit]Controversy

 

In 2001, the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication. They strengthened editorial restrictions to counter the effect. The editorial noted that contract research organizations had, by 2000, received 60% of the grants from pharmaceutical companies in the U.S. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.[40]

Seeding trials are particularly controversial.[41]

[edit]References

 

^ Avorn J. (2004). Powerful Medicines, pp. 129-133. Alfred A. Knopf.

^ Van Spall HG, Toren A, Kiss A, Fowler RA (March 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". JAMA 297 (11): 1233–40. doi:10.1001/jama.297.11.1233. PMID 17374817.

^ a b The regulatory authority in the USA is the Food and Drug Administration; in Canada, Health Canada; in the European Union, the European Medicines Agency; and in Japan, the Ministry of Health, Labour and Welfare

^ "Clinical trials in oncology". Stephanie Green, Jacqueline Benedetti, John Crowley (2003). CRC Press. p.1. ISBN 1-58488-302-2

^ "Clinical Trials Handbook". Shayne Cox Gad (2009). John Wiley and Sons. p.118. ISBN 0-471-21388-8

^ Curtis L. Meinert, Susan Tonascia (1986). Clinical trials: design, conduct, and analysis. Oxford University Press, USA. p. 3. ISBN 978-0195035681.

^ Toby E. Huff (2003), The Rise of Early Modern Science: Islam, China, and the West, p. 218. Cambridge University Press, ISBN 0-521-52994-8.

^ Tschanz, David W. (May/June 1997). "The Arab Roots of European Medicine". Saudi Aramco World 48 (3): 20–31.

^ D. Craig Brater and Walter J. Daly (2000), "Clinical pharmacology in the Middle Ages: Principles that presage the 21st century", Clinical Pharmacology & Therapeutics 67 (5), p. 447-450 [448].

^ "James Lind: A Treatise of the Scurvy (1754)". 2001. Retrieved 2007-09-09.

^ O'Rourke, Michael F. (1992). "Frederick Akbar Mahomed". Hypertension (American Heart Association) 19: 212–217 [213]

^ O'Rourke, Michael F. (1992). "Frederick Akbar Mahomed". Hypertension (American Heart Association) 19: 212–217 [212]

^ Glossary of Clinical Trial Terms, NIH Clinicaltrials.gov

^ Helene S (2010). "EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation". Pharm Med 24 (4): 223–229.

^ ICH Guideline for Good Clinical Practice: Consolidated Guidance

^ International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

^ What is informed consent? US National Institutes of Health, Clinicaltrials.gov

^ "Guidance for Industry, Investigators, and Reviewers". Food and Drug Administration. January 2006. Retrieved 2010-06-15.

^ The Lancet (2009). "Phase 0 trials: a platform for drug development?". Lancet 374 (9685): 176. doi:10.1016/S0140-6736(09)61309-X. PMID 19616703.

^ Silvia Camporesi (October 2008). "Phase 0 workshop at the 20th EORT-NCI-AARC symposium, Geneva". ecancermedicalscience. Retrieved 2008-11-07.

^ http://www.medscape.com/viewarticle/582554_2

^ "Guidance for Institutional Review Boards and Clinical Investigators". Food and Drug Administration. 1999-03-16. Retrieved 2007-03-27.

^ "Periapproval Services (Phase IIIb and IV programs)". Covance Inc.. 2005. Retrieved 2007-03-27.

^ Arcangelo, Virginia Poole; Andrew M. Peterson (2005). Pharmacotherapeutics for Advanced Practice: A Practical Approach. Lippincott Williams & Wilkins. ISBN 0781757843.

^ Web Site Editor; Crossley, MJ; Turner, P; Thordarson, P (2007). "Clinical Trials - What Your Need to Know". American Cancer Society 129 (22): 7155. doi:10.1021/ja0713781. PMID 17497782.

^ Yamin Khan and Sarah Tilly. "Seasonality: The Clinical Trial Manager's Logistical Challenge". Pharm-Olam International (POI). Retrieved 26 April 2010.

^ Yamin Khan and Sarah Tilly. "Flu, Season, Diseases Affect Trials". Applied Clinical Trials Online. Retrieved 26 February 2010.

^ Assembly Bill No. 2328

^ Back Translation for Quality Control of Informed Consent Forms

^ Common Dreams

^ Pmda.go.jp 独立行政法人　医薬品医療機器総合機構 (Japanese)

^ ICH

^ "Tax Credit for Testing Expenses for Drugs for Rare Diseases or Conditions". Food and Drug Administration. 2001-04-17. Retrieved 2007-03-27.

^ Paul, J. .; Seib, R. .; Prescott, T. . (Mar 2005). "The Internet and clinical trials: background, online resources, examples and issues" (Free full text). Journal of medical Internet research 7 (1): e5. doi:10.2196/jmir.7.1.e5. PMC 1550630. PMID 15829477. edit

^ http://www.pdtrials.org/en/about_PDtrials_what

^ http://www.mlanet.org/resources/hlth_tutorial/mod4c.html

^ http://www.pdtrials.org/en/participate_clinicalresearch_how

^ Life on a Trial - What to Expect

^ Life Sciences Strategy Group, "Clinical Trial Technology Utilization, Purchasing Preferences & Growth Outlook" Syndicated Publication, May, 2009

^ Davidoff F, DeAngelis CD, Drazen JM, et al (September 2001). "Sponsorship, authorship and accountability". CMAJ 165 (6): 786–8. PMC 81460. PMID 11584570.

^ Sox HC, Rennie D (August 2008). "Seeding trials: just say "no"". Ann. Intern. Med. 149 (4): 279–80. PMID 18711161. Retrieved 2008-08-21.

Rang HP, Dale MM, Ritter JM, Moore PK (2003). Pharmacology 5 ed. Edinburgh: Churchill Livingstone. ISBN 0-443-07145-4

Finn R, (1999). Cancer Clinical Trials: Experimental Treatments and How They Can Help You., Sebastopol: O'Reilly & Associates. ISBN 1-56592-566-1

Chow S-C and Liu JP (2004). Design and Analysis of Clinical Trials : Concepts and Methodologies, ISBN 0-471-24985-8

Pocock SJ (2004), Clinical Trials: A Practical Approach, John Wiley & Sons, ISBN 0-471-90155-5

[edit]External links

 

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

The International Clinical Trials Registry Platform (ICTRP)

IFPMA Clinical Trials Portal (IFPMA CTP) to Find Ongoing & Completed Trials of New Medicines

ClinicalTrials.gov

Clinical Trials for cancer research - National Cancer Institute

[hide]v · d · eBiomedical research: Clinical study design / Design of experiments

Overview

Clinical trial · Clinical trial protocol · Clinical trial management · Academic clinical trials

Controlled study

(EBM I to II-1; A to B)

Randomized controlled trial (Blind experiment, Open-label trial)

Observational study

(EBM II-2 to II-3; B to C)

Cross-sectional study vs. Longitudinal study, Ecological study

Cohort study (Retrospective cohort study, Prospective cohort study)

Case-control study (Nested case-control study)

Case series · Case study / Case report

Epidemiology/

methods

occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence)

association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio)

other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratios · Pre/post-test probability

Trial/test types

In vitro / In vivo · Animal testing · Animal testing on non-human primates · First-in-man study · Multicenter trial · Seeding trial · Vaccine trial

Analysis of clinical trials

Risk-benefit analysis

Interpretation of results

Selection bias · Correlation does not imply causation · Null result

Category · Glossary · List of topics

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[mrd]

As I mentioned b4 you might be onto something but you have a high bar of evidence to mount when you are talking about scientific evidence. As I said what you have presented warrants further investigation but you have been presenting minimal real evidence. You need to overcome skeptics not people here who are all rah rah and gung ho.

[peanutbutter]

You need to overcome skeptics not people here who are all rah rah and gung ho.

 

Why?

 

His doctors are convinced.

 

Why do I need to convince you?

[peanutbutter]

Lets make this clear ..

 

What you are asking me for is evidence against myself.

 

You are not asking for proof of a medical claim.

[mrd]

That is the way you might be taking it because you are involved. I am not suggesting you disprove anything. Unless you discover something you thought was true was wrong. (of course the reverse is true too) I am not suggesting that your opinion is invalid. But when you suggest something cures something like cancer you either make statements where you bring forth your hypothesis such as that you came up with the idea that your oil might have a positive effect on what type of specific cancer (since all cancers are not alike) you believe your approach might work on. Then you carefully describe the situation. Age of patients, any other problems that might affect the test, location of cancer, how it was/is manifested, measured size of the the cancer., what the treatment is , how it was derived, it's constituent parts, dosage in terms of strength and application, interval of treatment, evidence taken on the way, evaluation of evidence, who evaluated the evidence , what basis for the state of the disease those evaluating used.

 

All this just to be taken seriously. To be seen as something more than a medicine man. (medicine men might cure things but their level of proof is non existent. ( I might be leaving out things through ignorance, sorry)

 

Then you get to say that if so that the evidence presented on such a small test is positive that it seems to support your hypotheses that it cures this type of cancer (or not if the evidence suggests otherwise.

 

Then you go onto real testing with larger groups, elimination of extraneous factors rigorous testing , models for testing. I am sure you could find those engaged in such things at the local universities who can go into depth about this..

 

As I said I really want your approach to be effective. It's fine with me if you profit off it too. But if your going to say that something cures cancer then you really have put the burden of proof on your own shoulders.

 

You even have to be willing to scientifically state when something does not work and you have to provide the same quality of information even if your hypothesis is incorrect.

 

That certainly does not sound like fun. As I said before I am not saying what your doing is wrong or ineffective, I am talking about what is needed to be taken seriously in a world where medical science plays a part.

 

For those of you who do not believe in science don't start your car, make a phone call, take any prescription drugs, use tap water etc. Almost everything we do and utilize uses science to achieve its goals. /Each discovery builds on another so making sure things work is vital.

 

Most of science is a slog through have semi frozen mud, very tedious. Right now what your doing might be working on an individual but as I mentioned before it might indicate further investigation is warranted not that it is an absolute cure for everyone similarly afflicted or with different types of cancers. Might be but proving that requires a tremendous amount of work.Its a really huge statement to say anything is a cure. As I said before either you achieve something so huge that no one can deny it. Such as the Wright brothers proving that heavier than air human flight was possible. ( They took movies too). Hard to deny since most things fell to earth rather quickly. Or you prove statistically that you have made a significant difference. As an example you take 100 people who have a deadly cancer where 95% will be dead in one year and you treat them with something and after a year only 85% are dead. If you created a sound experiment and upon repeating it you get the same results, that would be considered a big deal. But it by it's nature be a royal pain in the posterior.

 

I am fine with you doing, and it is not about you. If it was anyone else the same things apply. but I just want to stress that even a doctors opinion should be based on science. The doctor may be more qualified to do so than a layman but they still have to provide verifiable and repeatable evidence. Doctors have been wrong, some doctors have lied in situations. I am sure you have met doctors who you felt were full of themselves and not even listening to you. It's like that old joke Whats the difference between God and a doctor? God doesn't think he is a doctor.

 

You are obviously trying to achieve something admirable and you might be getting good results it just ain't an easy row to hoe.

 

Unfortunately, If you don't hold your own feet to the fire than others will do it for you. The closer to using scientific method you are and using it in presenting your findings the more undeniable your claims become.

 

I would like it if any of those who are doctors and or researchers to review what I said and if I am wrong or they can improve on what I said then they should since anything I say should come under at least as much scrutiny as I have given to your words.

 

What your doing is admirable, do not stop, just consider your approach and try to shore up any weak areas in terms of execution of tests and evaluation of the results.

[peanutbutter]

I have a chest and head cold today .. and I'm tired.

 

I'm signing off the internet and the phone lines for today.

[mrd]

That is the way you might be taking it because you are involved. I am not suggesting you disprove anything. Unless you discover something you thought was true was wrong. (of course the reverse is true too) I am not suggesting that your opinion is invalid. But when you suggest something cures something like cancer you either make statements where you bring forth your hypothesis such as that you came up with the idea that your oil might have a positive effect on what type of specific cancer (since all cancers are not alike) you believe your approach might work on. Then you carefully describe the situation. Age of patients, any other problems that might affect the test, location of cancer, how it was/is manifested, measured size of the the cancer., what the treatment is , how it was derived, it's constituent parts, dosage in terms of strength and application, interval of treatment, evidence taken on the way, evaluation of evidence, who evaluated the evidence , what basis for the state of the disease those evaluating used.

 

All this just to be taken seriously. To be seen as something more than a medicine man. (medicine men might cure things but their level of proof is non existent. ( I might be leaving out things through ignorance, sorry)

 

Then you get to say that if so that the evidence presented on such a small test is positive that it seems to support your hypotheses that it cures this type of cancer (or not if the evidence suggests otherwise.

 

Then you go onto real testing with larger groups, elimination of extraneous factors rigorous testing , models for testing. I am sure you could find those engaged in such things at the local universities who can go into depth about this..

 

As I said I really want your approach to be effective. It's fine with me if you profit off it too. But if your going to say that something cures cancer then you really have put the burden of proof on your own shoulders.

 

You even have to be willing to scientifically state when something does not work and you have to provide the same quality of information even if your hypothesis is incorrect.

 

That certainly does not sound like fun. As I said before I am not saying what your doing is wrong or ineffective, I am talking about what is needed to be taken seriously in a world where medical science plays a part.

 

For those of you who do not believe in science don't start your car, make a phone call, take any prescription drugs, use tap water etc. Almost everything we do and utilize uses science to achieve its goals. /Each discovery builds on another so making sure things work is vital.

 

Most of science is a slog through have semi frozen mud, very tedious. Right now what your doing might be working on an individual but as I mentioned before it might indicate further investigation is warranted not that it is an absolute cure for everyone similarly afflicted or with different types of cancers. Might be but proving that requires a tremendous amount of work.Its a really huge statement to say anything is a cure. As I said before either you achieve something so huge that no one can deny it. Such as the Wright brothers proving that heavier than air human flight was possible. ( They took movies too). Hard to deny since most things fell to earth rather quickly. Or you prove statistically that you have made a significant difference. As an example you take 100 people who have a deadly cancer where 95% will be dead in one year and you treat them with something and after a year only 85% are dead. If you created a sound experiment and upon repeating it you get the same results, that would be considered a big deal. But it by it's nature be a royal pain in the posterior.

 

I am fine with you doing, and it is not about you. If it was anyone else the same things apply. but I just want to stress that even a doctors opinion should be based on science. The doctor may be more qualified to do so than a layman but they still have to provide verifiable and repeatable evidence. Doctors have been wrong, some doctors have lied in situations. I am sure you have met doctors who you felt were full of themselves and not even listening to you. It's like that old joke Whats the difference between God and a doctor? God doesn't think he is a doctor.

 

You are obviously trying to achieve something admirable and you might be getting good results it just ain't an easy row to hoe.

 

Unfortunately, If you don't hold your own feet to the fire than others will do it for you. The closer to using scientific method you are and using it in presenting your findings the more undeniable your claims become.

 

I would like it if any of those who are doctors and or researchers to review what I said and if I am wrong or they can improve on what I said then they should since anything I say should come under at least as much scrutiny as I have given to your words.

 

What your doing is admirable, do not stop, just consider your approach and try to shore up any weak areas in terms of execution of tests and evaluation of the results.

 

I got this synopsis of an Israeli cannabis study on Crohn's Disease fromNorml's website today. Although they got positive results look at their wording as far as how they interpreted the results. Look at how they defined the problem. Of course they had a larger group and they do not live in a country like ours that surpresses cannabis related research still it is their approach that I am reffering to. Hope you feel better, soon.

 

 

Treatment of Crohn’s disease with cannabis: an observational study

via PubMed

Isr Med Assoc J. 2011 Aug;13(8):455-8.

 

BACKGROUND: The marijuana plant cannabis is known to have therapeutic effects, including improvement of inflammatory processes. However, no report of patients using cannabis for Crohn’s disease (CD) was ever published.

 

OBJECTIVES: To describe the effects of cannabis use in patients suffering from CD.

 

METHODS: In this retrospective observational study we examined disease activity, use of medication, need for surgery, and hospitalization before and after cannabis use in 30 patients (26 males) with CD. Disease activity was assessed by the Harvey Bradshaw index for Crohn’s disease.

 

RESULTS: Of the 30 patients 21 improved significantly after treatment with cannabis. The average Harvey Bradshaw index improved from 14 +/- 6.7 to 7 +/- 4.7 (P < 0.001). The need for other medication was significantly reduced. Fifteen of the patients had 19 surgeries during an average period of 9 years before cannabis use, but only 2 required surgery during an average period of 3 years of cannabis use.

 

CONCLUSIONS: This is the first report of cannabis use in Crohn’s disease in humans. The results indicate that cannabis may have a positive effect on disease activity, as reflected by reduction in disease activity index and in the need for other drugs and surgery. Prospective placebo-controlled studies are warranted to fully evaluate the efficacy and side effects of cannabis in CD.

Edited September 17, 2011 by mrd

[bumrush]

Bumrush you seem to have misunderstood. the purpose of a Devils Advocate is to take the other side. It is to force a refinement of thinking and perhaps action in the process. It makes no difference to me that I am not a cheering squad. You want it to work so you have a problem with anyone who is critical. I want it to work, so I am critical. My way is better for if the experimenter ie PB provides proof using the scientific method then it is likely A. To really work

B. Have a chance of getting to many people and making a big change.

 

If I didn't want it to work I would not bother.

 

You go well beyond DA. You insult by implication a person who would give their life for a stranger and has sacrificed a great deal of treasure and time for more people than any human can count.

 

[Ten4GoodBuddys]

Somehow our society has gotten to this point where some think it is necessary to prove effectiveness to protect from liability before use. Humankind is too ignorant to take this approach. Simply if we have a government who is refusing to fund proper research, we as a society are not in the advanced state one who requires science to validate a treatment before its use.

 

Scientists need to prove things.

 

Healers need to keep healing the sick until the scientists are able to prove.

 

mrd, We are far from the utopia which would make your devils advocacy valid.

Edited September 17, 2011 by Ten4GoodBuddys

[MightyMightyMezz]

Cannabis oil on cancer is far more than ready for "serious discussion." I'm sure. There is no need to jump through hoops to earn the acknowledgment of the medical establishment. If they haven't screamed at the government to allow scientific research on Cannabis by now, they are going to do everything possible to stall. Better to think big and make high CBD Simpson Oil and Peanutbutter's Topical Oil available to every cancer patient in the state. If cancer survival skyrockets then we're golden. If it doesn't, then time to start other avenues of research.

Edited September 17, 2011 by MightyMightyMezz

[mrd]

Well if your going to take that route please understand that it is best to make no medical claims. You really will have to couch your words or the FDA will fall on you like a ton of bricks. You probably have seen those disclaimer ( no I just buy stuff from them and I get nadda from them. If not check out a site like swansons.com which is a decent enough place to find herbals and every kind of vitamin in existence , but you will see disclaimer after disclaimer referring to how the whatever is not meant to cure disease etc. It makes no difference what they really believe that disclaimer is to stop the feds from coming down on them. You probably should have a signed contract stating the same. You might say something that some people have found that it is useful for pain and nausea etc but that you make no claim. or what ever legalize that is better.

 

As far as prescription drugs go they have had some great success but there have been numerous cases where insufficient study was done or else things were alluded to that were not tested. Cases where you cure one thing but the side effects show years later.

 

Now if the oil/cannabis was shown to be repeatedly helpful in healing lost causes of cancer then you have major evidence. You can probably find out what would be significant by asking a researcher in that field. Call a few places make some polite inquiry or look it up. Then All the scientific proof is not needed due to the significant and obvious weight of the evidence. Works for me.

 

i had a talk with Justbudz a while a go and we were discussing oil and cures and he expressed disappointment that some cannabis treatment did not cure all of a type of cancer. I told him that increasing survival 10% would be great. Especially if it was one of us or someone we cared about. If you save 10k people out of 100k that 10% might seem small on paper but if you got to meet and shake hands with 10k people who otherwise would be dead then i think the good effect would be clear.

 

But when we talk about curing people either they have to be totally f'd or else you have to get into detailed proff. But even for the imaginary 6 people who the oil saved you still need documented scientific collaboration of the the persons illness and the subsequent change.

 

then PB will need a pit bull and lawyer to keep the drug companies and those darned scientists from beating down his door with notebooks and checkbooks in hand.

 

Just avoid making claims that do not have the weight of evidence and scientific evaluation or else they will just put you on a spit and roast you. Make it happen just show what outsiders consider adequate proof so they cannot deny you. If you got something then getting your act together on proof will only benefit you.

[MightyMightyMezz]

I'm savvy enough not to make medical claims. I understand there is research indicating CBD may have powerful anti-cancer properties. cbd cancer I want high-CBD strains to be widely available so people can see for their selves. I'll probably just order some Cannatonic seeds because I don't want to be beholden to someone else's idea of how to do things.

[peanutbutter]

I got this synopsis of an Israeli cannabis study on Crohn's Disease fromNorml's website today. Although they got positive results look at their wording as far as how they interpreted the results. Look at how they defined the problem. Of course they had a larger group and they do not live in a country like ours that surpresses cannabis related research still it is their approach that I am reffering to. Hope you feel better, soon.

 

 

Treatment of Crohn’s disease with cannabis: an observational study

via PubMed

Isr Med Assoc J. 2011 Aug;13(8):455-8.

-- snip --

 

Something like this on Crohn's, UC, IBD and Gerd?

http://michiganmedicalmarijuana.org/topic/31752-crohns-vs-pb-oil/page__st__60

[peanutbutter]

BTW inadvertently there has been something of a double blind.

 

Someone donated some liquid to me for my work. This was from some material that he had left soak overnight in iso alcohol.

 

We reduced the remaining alcohol and had the result tested. Somehow there was very close to zero THC in the resulting "oil."

 

When I had been handed the liquid, the person told me that he used this liquid for his topicals.

 

I handed his one of my oil kits while I was there.

 

A couple of months later I received feedback that the topical oil from me didn't seem to work. Odd ..

 

After a few weeks I remembered the zero THC stuff.

 

I conclude that my topical oil, while having very little THC in it, depends on the THC to produce what effects it does.

 

Inadvertent double blind.

Edited September 18, 2011 by peanutbutter

[peanutbutter]

Major internal cancers.

 

I have an MRI disk. A set of scans from a patient.

 

First scan shows tumors in brain, both lungs and liver.

 

Last scan shows the tumor in the liver gone, the tumors in one lung gone, the tumors in the remaining lung difficult to see on the scan and the tumors in the brain greatly reduced.

 

I guess they will call that one spontaneous remission .. again.

 

Pure co incidence that hemp oil and my topical oil is being used at the same time as chemo etc.

[peanutbutter]

I also have a copy of a CT disk from another patient being obtained for me.

 

This patient also has a pretty massive brain tumor.

 

It is shrinking.

 

In both cases, the doctors say the same thing "What ever you're doing, keep doing it."

[peanutbutter]

Another patient .. this one I haven't received a copy of the MRI yet.

 

Patient claims:

 

Cancer tumors it two lobes of her liver.

Patient used my topical oil for the pain in her liver. Little else.

 

Patient claims the MRI shows that the tumor in one lobe is completely gone and the tumor in the second lobe has substantially reduced.

 

I'm waiting to see those cases where the documentation is crystal clear. No doubt about it. For anyone that is in the medical profession, there is no question.

 

That's why I'm so excited about this skin cancer case this thread started out about.

 

The experts in this area have been working with this patient for the last twenty five years. It is these same doctors that have labeled his case "cancer controlled by cannabis."

 

Once the medical profession has seen a few of these cases, then they can run with it.

 

My biggst hope is to get them involved.

Edited September 18, 2011 by peanutbutter

[peanutbutter]

http://biomedreports.com/2011090273805/medical-marijuana-inc-patent-pending-extraction-cannabidiol-cbd-possible-use-in-the-anti-tumor-and-anti-cancer-nutraceutical-and-pharmaceutical-industries.html

 

Medical Marijuana Inc. Patent Pending Extraction ---- Cannabidiol (CBD) Possible Use In The Anti-Tumor and Anti-Cancer Nutraceutical and Pharmaceutical Industries

[mrd]

As I said provide overwhelming cases with proper scientific records and proof evaluated positively by even skeptical qualified people makes the case. Those results if scientifically provable would be very exciting. Still you need to establish baselines of some sort. Number of remissions in that kind of situation etc. Average prognosis etc. It might be quite obvious but the more back up you provide the less doubts can enter the argument.

[peanutbutter]

As I said provide overwhelming cases with proper scientific records and proof evaluated positively by even skeptical qualified people makes the case. Those results if scientifically provable would be very exciting. Still you need to establish baselines of some sort. Number of remissions in that kind of situation etc. Average prognosis etc. It might be quite obvious but the more back up you provide the less doubts can enter the argument.

 

What you describe is called clinical trials.

 

Which require FDA approval before you begin.

[in vivo]

This is an interesting thread. Is there a site or forum that has updated information?