After a clinical trial is completed, the research team carefully analyzes information collected during the study to make decisions about the findings and any need for further testing, but the next steps can vary based on what phase of testing the trial was in.
- After a phase 1 or phase 2 trial, they decide whether to continue testing the treatment in the next phase, or stop because they don’t believe it’s promising enough.
- When a phase 3 trial is over, the researchers examine whether the new treatment was more effective or has fewer side effects than the current one that’s used. If it is, they submit an New Drug Application to the FDA so it can become the new standard of medical practice.
As you finish participating in a study, you might have some questions about what happens next. For instance, can you access the treatment after the study is over? Or how might you access the results of the trial when they’re published?
This guide will answer these questions, in addition to outlining your exit interview, and tips on adjusting back to your regular schedule.
Giving feedback on your experience in the study
Exit interviews with participants are a common way for researchers to listen to feedback at the end of a trial. They allow patients to voice what they perceived as benefits and drawbacks of their trial experience, which helps improve future experiences for participants. These interviews are typically conducted by study coordinators or trained research staff.
During these interviews, researchers may ask about your symptoms and side effects over the course of the trial. Also, they may be compared to interviews that were conducted before and during the trial.
Here are some questions you may be asked:
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What were your expectations at the beginning of the study?
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Which symptoms were most important to you to improve?
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What were the most meaningful changes during your treatment? When did they occur?
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Were there any unmet needs during your treatment?
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How could we improve the experience for other patients?
While these interviews mostly focus on how you felt during the study, they are also used to discuss trial results with participants. This is a good time to ask questions about the scientific findings of the completed study.
Here’s a list of topics that may be included in the discussion of study results:
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If you received the treatment being studied or a different one
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Answered research questions
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Unexpected results
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Studies they’re planning that will continue to study the treatment
Finally, exit interviews are a good time to ask researchers about keeping in touch once you’ve completed your trial. Accessing data from your participation in the study may be helpful for future doctor’s appointments or enrolling in another clinical trial.
Finding the published results of a study in which you participated
Since there are often many different hospitals where the study is being run, the clinical trial isn’t necessarily finished after you’re through participating. After all the sites finish collecting data and the trial ends, the medical team may write a scientific paper about the findings of a study.
You can find the publications by asking the sponsor, looking on PubMed, or searching through ClinicalTrials.gov. You can also request to sit down with the research team to go over the results together, or ask them how to access them yourself. If you meet with them, some questions you may want to consider asking include:
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How many people enrolled in the trial and how many finished the trial?
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What were the significant findings of the study?
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Will the treatment be moving on to the next phase of clinical trials?
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Will I have access to the treatment now that the trial is completed?
Accessing the new treatment after the clinical trial ends
After you finish participating in a study, you may be wondering if you can continue to access the treatment that was being provided (of course, if you don't want to continue on the treatment for any reason, you're not required to).
While researchers are not obligated to offer continued access to the treatment they’ve provided, they are required to inform you about your options before the study even begins. The doctors should outline if the treatment will be available after the study ends, and if it is, the informed consent form will make it clear exactly what the process will be to access it.
Here are some common ways that participants can access the study treatment after the trial is over:
- In many cases, the manufacturer of a treatment will make it available to volunteers after the study has ended, such as in an early stage trial where the researchers are going to continue testing it.
- Participants may be able to purchase the new treatment privately after the study ends.
- In situations where it will take some time before a treatment is accessible to the patients who participated, they will often be given the best treatment that is already FDA approved for their condition first.
Sometimes the completion of one study will automatically make you eligible for the next study in the research process. The trial coordinator should make this clear to you, and the decision to continue participating will be entirely yours to make. At a minimum, you may be able to continue working with the treatment team involved with the study for your regular care. The doctors will also ensure that all participants have access to the data detailing what diagnostic and therapeutic methods were identified as the most effective for them.
Readjusting to life after a trial
Like any major life change, readjusting to life after completion of your trial will take time. You may have grown used to the support of your clinical trial team, the companionship of other participants, and the demanding time commitment. With all of these things suddenly over, you may find that you have more questions about the future of your health and treatment. Prioritizing your health, connecting with other patients, and remembering to do the things you love can help you smoothly transition back to your daily life.
Continue monitoring your health and taking care of yourself
Keeping a diary even after the completion of the trial can help you keep track of your health and adjust smoothly. Actively monitor your condition and continue to follow your normal routines to maintain and better your health. Discuss your health and wellbeing after the clinical trial with your primary physician, medical team, and loved ones.
Write messages to those who have helped you along the way
Some patients find it rewarding to reflect on the people who’ve offered support during their trial. From short thank you notes to handwritten letters, it’s always worthwhile to thank that friend who drove you to trial appointments, the nurse you bonded with at the study site, or the loved ones who have offered words of encouragement.
Connect with a community of patients
Engaging with other patients who have been through similar situations either in-person or online can be helpful and encouraging when adjusting back to your daily life. Join a support group, participate in a fundraiser or charity walk, or simply chat with fellow patients. Social media and online support groups can be a great way to connect with people who understand what you went through, and how you are feeling after the fact.
Most of all, continue to do what makes you happy.
Whether it’s going on morning walks, cooking and eating with loved ones, or spending time in nature, re-introducing yourself to some of your favorite hobbies and habits will help to ensure a smooth transition back into daily life.
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