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

Jennifer A H Bell; Mary T Kelly; Karen Gelmon; Kim Chi; Anita Ho; Patricia Rodney; Lynda G Balneaves

doi:10.1002/cam4.3031

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

Cancer Med. 2020 Jun;9(12):4107-4113. doi: 10.1002/cam4.3031. Epub 2020 Apr 20.

Authors

Jennifer A H Bell^{1

2}, Mary T Kelly³, Karen Gelmon⁴, Kim Chi⁴, Anita Ho^{4

5

6}, Patricia Rodney⁴, Lynda G Balneaves⁷

Affiliations

¹ University of Toronto, Toronto, ON, Canada.
² Princess Margaret Cancer Centre, Toronto, ON, Canada.
³ University Health Network, Toronto, ON, Canada.
⁴ University of British Columbia, Vancouver, BC, Canada.
⁵ University of California, Oakland, CA, USA.
⁶ Centre for Health Evaluation & Outcomes Sciences, University of British Columbia, Vancouver, BC, Canada.
⁷ University of Manitoba, Winnipeg, MB, Canada.

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.

Keywords: clinical trials; oncology trials; research ethics; trial accrual; trial participants.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research / ethics*
Clinical Trials as Topic / methods*
Clinical Trials as Topic / psychology
Decision Making / ethics*
Female
Gatekeeping
Humans
Informed Consent / ethics*
Male
Neoplasms / therapy*
Patient Participation
Patient Selection / ethics*
Qualitative Research
Research Personnel / ethics
Research Personnel / psychology*
Surveys and Questionnaires

Grants and funding

CIHR/Canada