How are volunteers selected to test a medicine in human clinical trials before it is released for sale?
Saturday, February 18th, 2012 at
5:00 am
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Filed under: Alternative Medicine
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Some doctors, usually specialists, ask their patients. I have a gastroenterologist who does this.
Clinical trials are highly regulated by the FDA with a clear set of guidelines and procedures that must be followed. The selection of potential candidates must be clearly defined by a very specific criteria, which is in turn must also be approved by the FDA. This criteria largely depends on a number of factors, including the type of drug, age, lifestyle, etc.
Usually, there is two types of testing: compensated and uncompensated. The uncompensated is what most people are familiar with, which usually comes in the form of treating patients with a terminal illness or a disorder that currently has no effective treatments. The compensation for participation is being possibility of being cured or at least have improved symptoms instead of monetary values. The other form, compensated testing, is found typically in elective products, like cosmetics and weight loss pills, where the volunteer will get paid a certain amount upon completing the trial successfully and adhering to their protocols.
"How do they acquire the illness the medicine is designed to cure?" Humans aren’t lab rats, so it is unethical and illegal to induce any condition that alter health of an individual negatively. Again, the individuals selected must either already have the condition the product is intended to treat or at least show clear signs that they can benefit from its use. In most cases, even the latter is not enough to volunteer.
The first phase of a trial is on healthy volunteers who get paid. This phase of the trial is to make sure that the drug is safe for humans to take and to measure factors such as how long the drug stays in the body, the maximum tolerated dose etc
The next phase is to test it on people with the actual illness in question, these people generally do not get paid. Sometimes it can be difficult to test on people with the actual illness if it is a rare and dangerous disease. For example I knew of an anthrax vaccine trial, how it was done was that regular healthy people were given the anthrax vaccine, then a sample of their blood containing the vaccine was withdrawn and subjected to anthrax in a safe lab setting. Samples of their blood was takewn over a few years to test how long the vaccine was staying active.
So with your example of diabetes, yes there are already meds but meds can always be improved on. The health of the patient is always foremost so the patient will be monitored constantly while they are taking the trial med. If there’s a sign that the patients conditioning is worsening then action will be taken by the doctor. Of course most of these studies will be blinded, meaning that the doctor does not know if the patient is getting the trial med, a placebo or an alternative already on the market med. Placebos will not be used in studies where it would be bad for a patients health to take no drug – those trials would always compare against the market leader drugs
Why wouldn’t people who look to untested medicines when there is no alternative be any good? If somebody is ill, take something and then the illness goes – I think thats a pretty good result?!
Clinical trials use normal healthy individuals who volunteer and are paid. The next phase of the trial goes onto test subjects, subjects do not get paid (though sometimes they do), these people are motivated because they have a paricular disease and are as motivated to find improved medicines as any doctor or researcher.
There is a medical clinic near my work place. A few years ago they were testing a weight loss medicine. They had very specific criteria. You had to be in a certain age range, a certain weight range. You could not be under any other medication. You could not be a smoker.
Once a week (my time was 7:30 Monday mornings) I would report to be tested. They would take my blood pressure, urine sample, etc. I could not eat for 12 hours before I reported for testing.
This lasted for 14 weeks. After it was done, I received a check for $1200. I don’t know if the pill I was taking was the real thing or a placebo.
By the way, I weighed the exact same weight when I finished the study as I did when I started.