You have been receiving treatment as a part of a clinical trial. The program has been time-consuming. You have forged strong connections with the research study team. But then, the research comes to an end. What can you expect once your participation has concluded?
The Next Step
What follows is primarily dictated by the research phase and the collected data. Immediately after the trial, there will be a period where the data is assembled and analyzed. Understandably, it will take time to interpret the information. If the data shows the treatment is ineffective or causes adverse effects, the research will end. Alternatively, if the data is promising, the study will proceed into the next phase.
Phase I trials are used to determine if a treatment is safe. In phase II, researchers are looking at the effectiveness and the correct dosage. If the treatment is more effective or has fewer side effects than the current standard medical treatment, the trial proceeds to phase III. Phase III uses a broader distribution of participants to determine optimum dosages for different populations. A New Drug Application is filed with the FDA if phase III is successful.
Participants in one clinical phase may be able to continue in the next phase. However, the research team is under no obligation to continue with a particular participant. A participant may wish to continue the treatment at the trial’s end. If the treatment is deemed unsafe or ineffective, that will not be possible. The informed consent document signed before the start of the research explains the participants’ right to continue beyond the trial period. A review of that document will guide the next steps.
Every participant is given an exit interview at the end of each phase, conducted by study coordinators or research staff. The interview is an excellent time to ask questions about study results and the potential to continue. Participants may either be able to continue treatments as part of the next clinical trial phase, receive ongoing treatment under the care of their physician, or pay to receive the treatment through a third party.
It may take some time for the study results to be known, especially if the participation was a part of a much more comprehensive study. Ask the sponsor during the exit interview to provide information on the study outcome. Also, PubMed Central and ClinicalTrials.gov are good sources to monitor clinical trial results.
Getting Past the Letdown
Clinical trials can be time-consuming and energy-intensive. Therefore, it is reasonable to experience a letdown when the study is over. Suggestions for participants coping with a letdown include:
- Thanking those that helped during the trials.
- Establishing connections with other patients.
- Keeping a health diary.
- Doing things to inspire happiness.
Join a Clinical Trial
Altus Research, in Lake Worth, Florida, has extensive experience with clinical trial research. The Altus Research team of professionals is available to guide participants through every step in the process, including post-study advice and support. If you are interested in joining a clinical trial, contact us to learn about the current trials you can enroll in.