A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.
Cancer clinical trials are critical for testing new treatments, yet less than 5% of patients with cancer enroll in these trials. Minority groups, elderly individuals, and rural populations are particularly underrepresented in cancer treatment trials. Strategies for advancing equity in cancer clinical trials for these populations include (1) optimizing clinical trial matching by broadening eligibility criteria, screening all patients for trial eligibility, expanding the number of trials against which patients are screened, and following up on all patient matches with an enrollment invitation; (2) conducting site self-assessments to identify clinical-, patient-, provider-, and system-level barriers that contribute to low rates of clinical trial screening and enrollment; (3) creating a quality improvement plan that addresses the barriers to enrollment and incorporates the use of tools and strategies such as clinical trial checklists; workforce development and trainings to improve cultural competence and reduce unconscious bias; guides to promote community education, outreach and engagement with cancer clinical trials; screening and accrual logs designed to measure participation by demographics; models of informed consent that improve understanding; clinical trial designs that reduce accessibility barriers; use of cancer clinical trial patient navigators; and programs to eliminate barriers to participation and out-of-pocket expenses; and (4) working with stakeholders to develop both protocols that are inclusive of diverse populations’ geographic locations, and strategies to access those trials. These actions will support greater access for populations that have remained underrepresented in cancer clinical trials and thereby increase the generalizability and efficiency of cancer research.
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