Clinical Trials: What Are They, Where Are They, And Are They Right For You?

Clinical trials are health-based studies that are carried out in human patients and that are aimed at developing and confirming the safety and efficacy of new drugs and other treatments methods for treating and/or curing a particular disorder. These studies are conducted by various hospitals, research institutes and universities throughout the United States, but only after the protocols for carrying them out have been carefully reviewed and approved by the Food and Drug Administration (FDA).

Generally, each particular clinical trial program has its own team of doctors, nurses, social workers and other health professionals that carefully treat, monitor and otherwise care for each trial participant both throughout and after the duration of the trial study. Indeed, most clinical trial participants have far more contact with health professionals than they would if their condition were being treated outside the trial program.

Each trial program has its own guidelines regarding who may and who may not participate in the trial. These guidelines are not meant to discriminate against anyone on a personal level, but instead are meant to optimize the results of the study such that the most good is provided to the greatest number of people over the long run. Criteria that are used to include patients in, or exclude patients from, a trial include the patient's age and/or gender, stage of progression of their disease, prior treatment history and overall health not related to the particular disorder that is to be treated in the trial.

The advantages of participating in a clinical trial include the following:

• Satisfaction of helping to advance a pioneering medical treatment
• Exposure to new, state-of-the-art drugs and technologies long before they are used to treat patients in mass numbers
• Heightened and frequent attention that is provided by a large team of health professionals
• In some cases, the treatment provided in the trial may mean the difference between living and dying or otherwise improving and not improving

The risks associated with participating in a clinical trial include:

• The drug or procedure being tested may seriously harm, and possibly even threaten the life of, the participant
• The trial may have no positive effect on the health of the patient (whereas a more traditional treatment, had it been opted for, may have had a positive effect)
• The participant may find the trial to be prohibitively time-consuming, as it is often true that clinical trial programs require participants to visit the testing center much more often than they would if they were being treated according to a more traditional treatment scheme

If you have an illness that is in need of treatment and you may be interested in joining a clinical trial, you may wish to visit ClinicalTrials.gov. This U.S. Government web site provides a searchable database that contains information about the many thousands of clinical trials that are currently being offered not only in the U.S., but also around the world. Not only will this database allow you to search by particular illness, such as Crohn's Disease, breast cancer or heart disease, for example, but it also will allow you to include your home area (i.e., nearest large city) in the search to help you see which relevant trials are being conducted close to your home. When you identify a trial of interest by using this database, you can access the web page for that particular trial to see the exact nature of the trial, what is required of its participants, and its participant eligibility criteria, among other things.

If you find a clinical trial that may be right for you, it is recommended that you contact the institute that is responsible for conducting the trial to learn as much as possible about the trial to help you decide whether it is right for you. Such contact information typically is provided at the bottom of the trial's web page.

I hope this article has at least partially helped answer the questions "what are clinical trials", "how do I find them", and "are they right for me". Regardless of whether you decide to participate in a clinical trial, I wish you a full and speedy recovery.

MedLine Plus/U.S. Library of Medicine, Clinical Trials: http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

National Institutes of Health, Understanding Clinical Trials: http://clinicaltrials.gov/ct2/info/understand