Questions to ask before enrolling in a clinical trial

Participating in a clinical trial represents a commitment that needs to be carefully considered. Here is a non-exhaustive list of questions that you can ask to yourself, to your healthcare provider and to the research team to help guide your decision: 

Logistics: 

  • What is the schedule for the trial? 
  • Do I have the flexibility to miss work to attend appointments? 
  • How long is the trial? 
  • How many visits are required and at what frequency? 
  • What will be expected of me as a participant?
  • How will the results of the study be used? 

Eligibility requirements: 

  • Do I meet the eligibility requirements for this trial? 
  • What are the inclusion criteria?
  • What are the exclusion criteria?

Potential risks and benefits: 

  • What are the potential risks and benefits? 
  • What are my chances to receive the treatment or the placebo/standard of care?
  • Am I comfortable with the uncertainty associated with taking the treatment or placebo/standard of care? 

Study procedures: 

  • What are the required procedures (e.g., skin biopsy, blood test)?
  • At what frequency are they required?
  • Do these procedures have an impact on my daily activities?

Informed consent: 

  • Do I understand the information provided in the informed consent form? 
  • What will happen if I no longer want to participate in the study?
  • Do I have all the necessary information to make a thoughtful decision? 

Confidentiality: 

  • How will my clinical trial record be secured and protected throughout and after the study?
  • Who will be given access to my medical information?
  • What will happen with my medical record after completion of the clinical trial? 
  • How will the results of the study be used?  

Compensation and expense reimbursements

  • Is there compensation for my participation? 
  • Will my medical care be covered?
  • Are some expenses expected on my behalf and are they covered (e.g., parking tickets)?

Alternative treatments: 

  • Are other treatments possible for me? 
  • Are there more suitable trials for me?

Trial staff: 

  • What kind of support do I receive during and after the study? 
  • Who can I contact for medical or general questions?
  • What kind of medical assistance will I be provided?