Putting participants and study partners FIRST when clinical trials end early

Abstract

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 keyThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Lessons Learned from Approval of Aducanumab for Alzheimer's Disease

“…Early, abrupt termination can also have devastating effects on trial participants, particularly if they are unaware of the possibility of early stoppage and learn of it first through national news outlets rather than from their local study team (48). In response to such experiences with aducanumab and other trials halted early in 2018-2019, the Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group was formed (49). Participant FIRST issued 17 key recommendations to improve communication and support participants and their study partners when trials end early.…”

Decision making in clinical trials: Interim analyses, innovative design, and biomarkers

“…Efforts along these lines already have been made in recent AD trials, such as the A4 study, in which individuals with elevated amyloid are informed of their status and properly counseled. Under the auspices of the Alzheimer's Association, an important group known as the Participant FIRST (Follow‐Up Improvement in Research Studies and Trials) work group, has published recommendations to improve communication with research participants in case trials end early and identifying supports for those affected by early trial closure 58 …”

“…Under the auspices of the Alzheimer's Association, an important group known as the Participant FIRST (Follow‐Up Improvement in Research Studies and Trials) work group, has published recommendations to improve communication with research participants in case trials end early and identifying supports for those affected by early trial closure. 58 …”

“…Efforts along these lines already have been made in recent AD trials, such as the A4 study, in which individuals with elevated amyloid are informed of their status and properly counseled. Under the auspices of the Alzheimer's Association, an important group known as the Participant FIRST (Follow-Up Improvement in Research Studies and Trials) work group, has published recommendations to improve communication with research participants in case trials end early and identifying supports for those affected by early trial closure 58. The topics presented at the Fall 2020 Alzheimer's Association Research Roundtable continue to be a critical part of clinical trial design and decision making in clinical trials, and discussions during this Topic Meeting helped guide the field toward solutions.…”

AAIC® 2022: The promise of Alzheimer's research

“…This workgroup developed 17 recommendations for clinical trial sponsors, researchers, and staff about how to better communicate with study participants when trials end sooner than expected. The recommendations, which were announced at AAIC 2022, are available open access in Alzheimer's & Dementia : The Journal of the Alzheimer's Association 2 …”