Leaving a Clinical Trial
Participation in a clinical trial is voluntary, which means you can leave a clinical trial at any time.
Talk to Your Research Team
Before you leave a clinical trial, please let the research team know you have decided to withdraw and the reasons for leaving the study. This will help the team to prepare information for their detailed report on the clinical trial to the Food and Drug Administration (FDA).
Depending on the type of study you are participating in, leaving the study can be simple with a just few requirements to complete so you can transfer back to regular care. However, in some other cases, it may mean that you should be closely monitored until you are safely off the study drug or until regular care can be resumed.
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).