Barriers to Recruitment and Retention Among Underrepresented Populations in Cancer Clinical Trials: A Qualitative Study of the Perspectives of Clinical Trial Research Coordinating Staff at a Cancer Center.
Sumbul Yousafi, Pavani Rangachari, Margaret L Holland
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引用次数: 0
Abstract
Background: Although US research agencies have instituted peer review processes to require participant diversity in clinical trials before funding decisions are made, the underrepresentation of certain populations (eg, racial and ethnic minorities) in clinical trials remains a persistent challenge in biomedical research. This issue has the potential to affect the generalizability of findings and impede efforts to ensure the provision of high-quality healthcare across all populations. In this study, we examined barriers to the recruitment and retention of underrepresented populations in cancer clinical trials from the perspective of research coordinating staff.
Methods: Semi-structured interviews were conducted at a US-based academic cancer center and included 6 patient-facing staff (clinical research coordinators) and 6 non-patient-facing staff (regulatory and financial specialists). Interview data were subjected to thematic analysis. To provide additional organizational context, descriptive data were obtained on the characteristics of clinical trials undertaken at the cancer center.
Results: The following themes emerged from the staff interviews: 1) absence of a consistent structure for decision-making and problem-solving related to recruitment and retention, 2) staff shortages, 3) administrative burden, and 4) lack of resources. In addition, descriptive data revealed that nearly half the trials, 64/134 (48%), offered informed consent only in English, and only 3/134 (2%) offered participant incentives or reimbursement (eg, for transportation). These interrelated organizational issues were indicative of inadequate systems for ensuring diverse and equitable representation in cancer clinical trials.
Conclusion: Results indicate that overcoming barriers to underrepresentation may require dedicated support from sponsoring agencies in the form of evidence-based guidelines, learning collaboratives to facilitate implementation, technical support, resources, and oversight. For progress to be made therefore, both sponsors and cancer centers may need to assume joint responsibility for the implementation of effective systems for ensuring diverse and equitable representation in cancer clinical trials.
期刊介绍:
Efficient and successful modern healthcare depends on a growing group of professionals working together as an interdisciplinary team. However, many forces shape the delivery of healthcare; changes are being driven by the markets, transformations in concepts of health and wellbeing, technology and research and discovery. Dynamic leadership will guide these necessary transformations. The Journal of Healthcare Leadership is an international, peer-reviewed, open access journal focusing on leadership for the healthcare professions. The publication strives to amalgamate current and future healthcare professionals and managers by providing key insights into leadership progress and challenges to improve patient care. The journal aspires to inform key decision makers and those professionals with ambitions of leadership and management; it seeks to connect professionals who are engaged in similar endeavours and to provide wisdom from those working in other industries. Senior and trainee doctors, nurses and allied healthcare professionals, medical students, healthcare managers and allied leaders are invited to contribute to this publication