Clinical Trials

Talking with Your Doctor

Patient with doctor

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 tests 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 the side effects of the standard treatment?
  • How might this trial affect my daily life?
  • How will I know that the treatment is working? Will the results of the trials be provided to me?
  • If I withdraw, will this affect my normal care?
  • Resources

    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).