Clinical trials are designed with a rigorous timeline and process to collect information about a new intervention. Depending on the goals, your trial may take several months or several years. The expected duration of the trial is usually known at the beginning of the process, and should be clearly defined in your consent forms.
Your trial team should make sure you are aware that the trial is coming to an end. You might expect:
- This is the final visit during the trial when you may receive treatment.
- You should expect this last visit to be like the others, with similar monitoring, testing and other evaluations.
- You may also meet with your trial team to talk about your outcomes, confirm your transition plans with your HTC and share feedback.
- Some trials may have a period of ongoing evaluation after your treatment schedule ends.
- During this time, you may receive phone calls, emails, or online questionnaires.
- Even after your treatment period is complete, continue to report any new symptoms or side effects to your trial team.
- Some trials may also have a follow-up call or detailed participant survey after the active portion ends.
- During these evaluations, your trial team may ask about how your experience in the trial went, ask about your outcomes versus your expectations and ask for your feedback on the overall process.
Transitioning from a gene therapy trial
Trials of newer gene therapy treatments are unique because in many cases they involve only a single infusion. If you are considering joining a gene therapy trial, your post-trial experience will involve regular blood tests and monitoring for several years after your infusion. You should expect the trial team will check in with you for many years following your participation to understand if the gene therapy is still working for you.
What next? Your post-trial transition plan
- What: A plan of how you’ll finish your part in the trial and return to a non-trial treatment plan with your HTC, including potential changes in medications; be sure to discuss opportunities to stay on the treatment, which is sometimes available through the sponsor at no cost to you for a period after the trial ends until the medication is approved by the FDA
- Who: To be coordinated with your hematologist and your trial team
- When: 2-3 months before you complete your last visit in the trial
A big change
It’s important to be prepared for a significant change in your treatment routine as a trial ends. Often in a trial you will speak with or visit your provider every few weeks for treatment and monitoring. After a trial, you will likely go back to a more typical visit schedule, perhaps every several months. Talk with your HTC team to make sure you feel comfortable with your schedule and have the support you need during this change.
So, was the trial a success?
After a trial concludes, the trial sponsor (named in your consent) will review the findings from all participants, analyze the results and report the findings. In some cases, this may be done in a matter of months; in trials with longer follow-up periods, it may take several years. It also depends where you entered the clinical trial. If you joined early in the study, it will take longer to learn the results compared to if you started near the end of recruitment.
Your hematologist will have your own results from the trial, but if you are curious about the overall outcomes, contact your trial team. Often the sponsor will make information available on their website, or through a presentation at a medical conference or in a journal publication. Your trial coordinator can help you find and understand those results.
Depending on the results and the phase of the trial, the sponsor may plan another clinical trial or may be ready to submit the results to gain regulatory approval of the treatment. With that approval, the treatment can be available for prescription.
Key Questions to Ask
Highlights to Remember:
- Be prepared for end of trial visits and questionnaires to document your outcomes. Your trial team welcomes feedback on your experience!
- Work with your trial team on a transition plan as you complete your participation.
- Seek opportunities to learn about the trial results and what they may mean for future treatment standards.