Did you know you could sign up to be a guinea pig for medical research? That’s right – you could become a test subject in a clinical trial for everything from testing new medical devices, to the latest drugs for combating cancer, heart disease or diabetes.
For some seriously ill patients, a clinical trial for a new cancer therapy or other life-threatening condition could be their only hope. And the National Institutes of Health (NIH) even helps sell the idea of being part of a clinical trial on this premise. Their site at http://www.clinicaltrials.gov says “Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research,” in answer to the question of “Why participate?
The NIH help conduct these studies, and vet the results to the Food and Drug Administration. However – that doesn’t mean this is a safe way to get medical care. Remember these are ‘trials’ and nobody knows for certain what the results may be. They are experiments conducted on humans, based on animal studies.
Certain people will be excluded from a clinical trial, for a variety of reasons, including their condition health. Each scientist conducting the research has to develop a strict protocol of how, and to whom, they will be administering any new form of drugs or therapies. If the new method is more likely to kill you than whatever condition you have, then you will most likely be excluded.
Before a clinical trial is started, the organization wanting to conduct the study has to convene its Institutional Review Board, comprised of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. The members of the board are not supposed to be directly connected with the research being conducted and remain completely objective on the study.
Initial clinical trials are usually very limited in their scope, with 100 to 200 participants for the trial. The results are then analyzed, and a determination is made on whether or not a broader trial will be safe to conduct. Participation in an initial clinical trial involves very controlled conditions, and the participants are carefully screened according to the criteria established by concurrence with the IRB.
Taking part in a trial also has another factor most people don’t consider – that they are taking part in what is called a double-blind test, in which half the participants receive the actually drug, and half do not. And nobody is certain who is who, except for a randomized code assigned to each participant that is later inserted into the results data. That is normal part of the scientific process, in which one group is a control, and nothing is done beyond making them feel as if they are part of the experiment. They receive placebos – which look identical to the actual drug, but are usually just sugar or an inert substance that pass through the body harmlessly.
However, in some circumstances, the actual drug is administered to everyone involved, because the illness being studied is inevitably fatal in a very short time.
So, go read up on clinical trials. Some of them actually sound like they might be fun to participate in – if you aren’t sick. You can find all the details at the NIH’s Clinical Trials Website.
