A checklist of important questions to ask before enrolling in a clinical trial.
Write these down. Bring them to your screening appointment or call the coordinator. Take notes on the answers.
1. What phase is this trial?
2. Is there a placebo arm? If so, how are participants assigned to groups?
3. What happens if I get the placebo? Is there an open-label extension where I can access the real drug afterward?
4. How often do I need to visit the trial site?
5. How long does the trial last?
6. What tests and procedures will I need?
7. What are the known side effects?
8. If I have a serious side effect, how will that be handled?
9. Can I continue my current medications while in the trial?
10. What happens after the trial ends? Will I have access to the drug if it works?
11. What costs will the trial sponsor cover? What will my insurance be billed for?
12. Will the trial reimburse travel, parking, or meals?
13. Who can I call if I have questions or concerns during the trial?
14. Can I leave the trial anytime?
15. How will my data be used? Who can see it?
There's no rush to decide. Yes, enrollment windows can close. But the research team would rather have thoughtful participants than people who enroll and then regret it. Ask all the questions. Get answers in writing. Read the informed consent carefully. Talk to your family, your doctors, your advocate organization.
If the site coordinator seems impatient or unwilling to answer your questions thoroughly, that's a red flag. You have the right to understand what you're agreeing to.