Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the “ideal” patient

Abstract

Background: Perspectives of clinical trial (CT) personnel on accrual to oncology CTs are relatively absent from the literature. This study explores CT personnel's experience recruiting patients to oncology CTs. Methods: A qualitative study design was utilized. In-depth, individual interviews with 12 oncology CT personnel were conducted, including six CT nurses and six physician-investigators. Interviews were digitally recorded and transcribed verbatim. Data were subjected to thematic and ethical analysis to identify key concepts and themes. Results: CT personnel reported considering two ethical commitments in CT recruitment: maintaining trial integrity and ensuring patient autonomy through obtaining informed consent. The process of gatekeeping emerged as a way to navigate these ethical commitments during CT accrual. Gatekeeping was influenced by: (a) perceptions of patients' personal suitability for a trial, and (b) healthcare resources and infrastructure. CT personnel's discernment of personal suitability was influenced by patients' cognitive and mental health status, language and cultural background, geographic location, family support, and disease status. Three structural factors impacted gatekeeping: complexity of CTs, consent process, and time limitations in the healthcare system. CT personnel experienced most factors as constraints to accrual and gaining patients' informed consent. Conclusion: CT personnel discussed navigating ethical challenges in CT recruitment by offering enrollment to specific patient populations, exacerbating other ethical tensions. Systems-level strategies are needed to address barriers to ethical CT recruitment. Future research should investigate the role of policies and/or tools (eg, decision aids) to support patients and CT personnel's discussions about CT participation, promote more ethical recruitment, and potentially increase accrual. K E Y W O R D S clinical trials, oncology trials, research ethics, trial accrual, trial participants How to cite this article: Bell JAH, Kelly MT, Gelmon K, et al. Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the "ideal" patient.

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