Understanding potential barriers and enablers to a perioperative early phase cell therapy trial

Background aims: Early-phase cell therapy clinical trials depend on patient and physician involvement, yet barriers can impede their participation. Methods: To optimize engagement for a planned cell therapy trial to prevent perioperative cardiac complications, the authors conducted semi-structured interviews with at-risk patients and physicians who could potentially be involved in the study. The authors used the theoretical domains framework to systematically identify potential barriers and enablers. Results: Forty-one interviews were conducted to reach data saturation, and four overall potential barriers to participation (themes) were identified. Theme 1 emphasizes that patients and physicians need accessible information to better understand the benefits and risks of the novel therapy and trial procedures and to address misconceptions. Theme 2 underscores the need for clarity on whether the trial's primary purpose is safety or efficacy, as this may influence patient and physician decisions. Theme 3 recognizes the resource and logistic realities for patients (e.g., convenient follow-up appointments) and physicians (e.g., personnel to assist in trial procedures, competing priorities). Theme 4 describes the importance of social influences (e.g., physicians and family, peers/colleagues) that may affect decisions to participate and the importance of patient preferences (e.g., availability of physicians to discuss the trial, including caregivers in discussions). Conclusions: Prospectively addressing these issues may help optimize feasibility prior to conducting an expensive, resource-intensive trial. (c) 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Automated summary

This study systematically identified potential barriers to participation in cell therapy clinical trials through interviews with high-risk patients and physicians. These barriers include difficulties in accessing information, unclear trial purposes, resource and logistic issues, and social influences. Therefore, targeted addressing of these issues is crucial for optimizing trial feasibility.