Do not hesitate to ask the following or any additional questions of the research team and/or healthcare professional associated with the clinical trial. You may want to bring a family member or caregiver with you to help make sure all of your questions are answered.
Questions to Ask Your Doctor (or Research Team)
- What is the purpose of the study?
- Who is going to be in the study? Inclusion and exclusion selection criteria?
- How long will the study last?
- What will happen at the end of the study?
- What kinds of test and exams will I be taking in the study? How much time do these take? What is involved in each test?
- Does the study compare standard and experimental treatments or will there be a “placebo”?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- Who will be in charge of my care?
- How will you keep my doctor informed about my participation in the trial?
- What are the costs to me? Will my health insurance pay for it?
- Will I be reimbursed for other expenses (e.g. parking fees, gas)?
- What type of follow-up care is part of this study?
- What are my other treatment choices (i.e. is there a current standard of care for my condition)? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of the standard treatment?
- How might this trial affect my daily life?
- How will I know that the treatment is working? Will results of the trials be provided to me?
- If I withdraw, will this affect my normal care?
- Search for Clinical Trials
- View or download What are Clinical Trials?—Your Questions Answered (Publication)
- The Phases of Clinical Trials (Article)
- Understanding Clinical Trials (Interviews with Scientists)
Sources of Information
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).