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Questions to contemplate before considering participating in a Clinical Trial

Back to Interventional Clinical Trials

The following are some potential questions to frame your discussion with a clinician and determine expectations before, during and after a clinical trial.

This is not a complete list, it is meant to give you some ideas on what you might like to ask when consulting a clinician. We suggest you choose the questions that are most important to you and think of more questions you may wish to ask.

About this trial

Participating

  • What exactly is a clinical trial?
  • What clinical trials are available for me to participate in?
  • Why do you think participating is a good idea for me?
  • Is there someone I can talk to who has been in the trial?
  • How long will the appointments be?
  • How often will I have appointments?

Details of the trial

  • What do the researchers hope to achieve from this trial?
  • Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
  • Can you provide information about this trial that I can review with my family doctor?

Technical Questions  

  • What does informed consent mean?
  • What kinds of tests and treatments are involved?
  • If I experience improvement during the treatment will I have access to the drug after the trial?
  • Will I be told about the trial’s results?
  • Will it be possible to continue receiving the treatment “off label” if it is shown to be effective?
  • How long do I have to make up my mind about joining this trial?
  • Who will know if I am on a placebo or the actual treatment?
  • What are the exclusions that would prevent me from participating in this trial?
  • Can I or should I bring a support person/ family member to my clinical trial appointments?
  • How long, if I choose to participant, will I be involved in this clinical trial?

Point of Contact Questions

  • Who can I speak with about questions I have during and after the trial?
  • Who will be in charge of my care?

Risks and Benefits

  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits?
  • How do the possible risks and benefits of this trial compare to those of the standard treatment?
  • What are my rights as a participant?
  • How will my health information be kept private?
  • What happens if I decide to leave the trial?

Costs

  • Where is the clinical trial located?
  • Will I have to pay for any of the treatments or tests?
  • Will my travel expenses be covered?
  • What is the process for reimbursement?
  • Who pays if I’m injured in the trial?
  • Who can help answer any questions from my insurance company?

How will this affect me?

  • Will information be shared with my family doctor or specialist?
  • How could the trial affect my daily life?
  • How often will I have to come to the hospital or clinic?
  • Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
  • Will I have check-ups after the trial?
  • How would participating in this clinical trial affect my ability to participate in other trials at the same time or at a later date?
  • Are there any dietary restrictions or instructions for this trial?
  • Will the treatment prevent me from working or participating in regular activities?
  • What if I have side effects? Who do I call? Which ones are serious and need immediate attention?

Treatment Choices

  • What are my other treatment choices, including standard treatments?
  • How does the treatment I would receive in this trial compare with the other treatment choices?
  • What will happen without treatment?

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