Deciding to Enroll
People with a medical condition or healthy individuals may consider participating in clinical trials. Each trial has its own protocol, or set of guidelines, and volunteers first must meet certain criteria to qualify for enrollment.
By enrolling in a clinical trial, a participant is making a noble effort to help test whether a candidate therapy (i.e., drugs, devices, or other study topics) has the potential to become a future drug, device, diagnostic test, prevention, or treatment for a particular disease or medical condition.
Volunteering for a clinical trial is also a way for participants to become actively involved in their own healthcare. However, there may be side effects or the treatments may not be effective, and participation will require a time commitment.
Before making a decision and giving their informed consent, each person should seek as much information as possible about the trial, and think seriously about the benefits and risks of volunteering. It is important to remember that a clinical trial is not a treatment, and the results of the trial could determine that the new treatment may not be better than the current standard of care.
U.S. Food and Drug Administration (FDA); National Institutes of Health (NIH); Center for Information & Study on Clinical Research Participation (CISCRP); Pharmaceutical Research and Manufacturers of America (PhRMA); Tufts Center for the Study of Drug Development [Updated Outlook 2010 and original referenced paper (DiMasi, Joseph A., Ronald W. Hansen and Henry G. Grabowski (2003) “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22(2):151-85, March)]; and a paper comparing the costs of different studies (Morgan, Steve, et al. “The cost of drug development: A systematic review” Health Policy 100 (2011) 4–17).