Participant FIRST Work Group releases recommendations to improve study participants’ experience when clinical trials end early

In an article published in Alzheimer’s & Dementia, a multidisciplinary work group released recommendations for improving communication with clinical trial participants when clinical research trials end early. The Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group consists of 31 members from various fields, including research participants and their study partners, patient advocacy organizations, researchers, academics, industry professionals, clinical trials study personnel, and representatives from the National Institutes of Health.

Most clinical trials run as planned from beginning to end, but sometimes trials are halted before the expected end date for various reasons, including unanticipated safety issues, evidence that the treatment is ineffective, or evidence that an intervention is effective, making continuation of the trial unethical. The work group formed after several Alzheimer’s disease clinical trials ended early in 2018 and 2019. Although sponsors had communication plans in place, many research participants and their study partners first learned about their trial’s premature ending through news coverage rather than through direct communication from personnel at their respective study sites. When a trial is sponsored by a publicly traded company, that company is required by law to quickly disclose this information, typically through a news release or press conference, because it could affect those with financial interests in the company. Because of this law, trial participants may hear about a trial’s ending via the media and before study site researchers can inform them.

The Participant FIRST Work Group met throughout 2021 with a focus on improving communication between research study personnel and participants in clinical trials, and to better support study participants in instances of a trial ending early. Its 17 recommendations are divided into pre-trial, mid-trial, and post-trial strategies. Examples of the recommendations include:

• Sponsors and funders should provide resources and funding to ensure orderly trial close-out in the study budget.
• Study personnel must address the possibility of early stopping during the informed consent process.
• Study personnel should regularly check and update contact information for participants and study partners.
• Study personnel should remind participants and study partners that clinical trials might end early.
• If a sponsor announces early stopping via a press release, that press release should explicitly address participants and study partners.
• Upon learning of early stopping, study sites should contact participants via email as soon as possible.

Learn more at Putting participants and study partners FIRST when clinical trials end early. For information about participating in clinical trials for Alzheimer’s and related dementias research, visit Alzheimers.gov Clinical Trials Finder.