Questions to Ask Before Participating in a Trial

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about the trial, the kind of care they will receive and the costs for the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• Is there a trial that will help me and for which I might be eligible?
  
  
• What is the purpose of the study? What stage (or phase) of development is the trial?
  
  
• What kind of tests and treatments are involved? For which of these will the costs be covered by the trial?
  
  
• What does the treatment do?  Has it been used before?
  
  
• Why do researchers believe the experimental treatment being tested may be effective?
  
  
• How do the possible risks, side effects, and benefits in this study compare with my current treatment?
  
  

• Will I know which treatment I receive? What happens if I get the placebo? 
  
  
• What is likely to happen to me with or without getting this treatment?
  
  
• What are my other choices and their advantages or disadvantages?
  
  
• How could the study affect my daily life?
  
  
• What side effects can I expect? Can the side effects be controlled?
  
  

• How might this trial affect my daily life?
  
  
• How long will the trial last? How many visits will I make to the center or the office for the trial?
  
  
• Will hospitalization be required? If so, for how often and how long?
  
  
• Will participating in the study cost me anything? Will my other non-study costs be covered by insurance?
  
  
• Will I be reimbursed for other expenses?
  
  
• If I am harmed as a result of this study, what treatment will I be entitled to?
  
  
• What type of long-term follow up care is part of this study?
  
  
• How will I know that the experimental treatment is working? Will results of the trials be provided to me?