If you have ever been involved in a clinical trial, you may have wondered what the next steps look like once the clinical trial ends. This article is meant to help you understand what the next steps might look like for you, for your research team, and for your community.
#1- You may or may not be able to continue treatment
After your participation in a clinical trial has ended, you may be able to continue as some studies are designed to allow access to the treatment for longer periods after the study is complete. If you did not receive the treatment in the study, some studies allow for an open label extension (OLE) where all participants get the treatment for an extended period, for purposes of collecting long-term data.
For some, compassionate use might occur in which the sponsor provides continuous treatment after the trial ends. This is typically for participants who are receiving life-sustaining treatment. Ultimately, none of these options are guaranteed, and it is important that you work with your research and care team to determine the next steps for your treatment plan.
#2-Treatment may or may not move to the next phase.
Whether or not a trial moves forward to the next phase depends on which phase the trial is in, and what the results of the trial look like. In phase 1 or 2, the researchers need to analyze the treatment effectiveness as well as participant safety. When a phase 3 trial is complete, the treatment can be submitted for U.S. Food and Drug Administration (FDA_ approval if the researchers find significant results.
You may be eligible to participate in the next phase of a clinical trial. Check with your doctor or research team to determine your eligibility.
#3-Treatment used in the trial may be approved for public use.
If a treatment in a phase 3 clinical trial is proven to be safe, effective, and medically relevant at the time of completion, the research team can submit it to be approved by the FDA, allowing it to become available for public use. Approval does not happen often, as research suggests that only about 10% of drug treatments from clinical trials successfully reach the market.
#4-Study results can be published in a peer-reviewed journal article.
It is typical for clinical trial results to be published in scientific journals. After the trial is completed, researchers will analyze the results, write a paper, and submit the paper for review. Peer review is a process where experts review a paper to make sure it meets scientific standards, to improve its quality, and confirm its validity. Participants of clinical research should ask the research team if their study results are available as well as where and when they may be published.
#5- If the study ends early, you will be contacted immediately.
Sometimes clinical trials are stopped early due to safety concerns, early success, or not having enough participants. If this happens, your research team will reach out to you immediately to discuss the reasons. Research suggests that early trial discontinuation is common at approximately 22% and mostly occurs due to limited success in recruiting participants.
Resources:
Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it? Acta Pharmaceutica Sinica B, 12(7), 3049–3062. https://doi.org/10.1016/j.apsb.2022.02.002
Zhang, E., & DuBois, S. G. (2023). Early termination of oncology clinical trials in the United States. Cancer Medicine, 12(5), 5517–5525. https://doi.org/10.1002/cam4.5385