Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement

Abstract

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.

Development and evaluation of a novel training program to build study staff skills in equitable and inclusive engagement, recruitment, and retention of clinical research participants

“…While this program iteration focused on staff development, as a next step we see value in using the ER&R program resources to design workshops for investigators to help them identify and mitigate these barriers before study protocols and budgets are finalized. The Just Ask content itself is a component of the recently released joint recommendations by the American Society of Clinical Oncology and Association of Community Cancer Centers for increasing racial and ethnic EDI in cancer clinical trials [30,31]. The Just Ask Training Program has already been widely adopted and used for 75 cancer clinical research sites nationally, including academic centers and community clinics, and was found effective in building awareness and skills toward addressing inequities in clinical research participation [30,31].…”

“…The Just Ask content itself is a component of the recently released joint recommendations by the American Society of Clinical Oncology and Association of Community Cancer Centers for increasing racial and ethnic EDI in cancer clinical trials [30,31]. The Just Ask Training Program has already been widely adopted and used for 75 cancer clinical research sites nationally, including academic centers and community clinics, and was found effective in building awareness and skills toward addressing inequities in clinical research participation [30,31]. Additionally, sponsors and agencies such as the NIH and FDA are taking crucial steps toward addressing barriers through policy and guidance for clinical studies conducted in partnership with, or funded by, them [32,33].…”

What proportion of patients with stage 3 ovarian cancer are potentially cured following intraperitoneal chemotherapy? Analysis of the long term (≥10 years) survivors in NRG/GOG randomized clinical trials of intraperitoneal and intravenous chemotherapy in stage III ovarian cancer

“…There was also no association with race, however, it should be noted that these studies included predominantly white patients (77.5%). Lack of racial and ethnic diversity has been recognised as a deficiency of cancer clinical trials [12]. LTDFS≥10 years represents the proportion of patients who are likely cured and had an exceptional response to first line treatment in a relatively favorable subset of patients with Stage III ovarian cancer who had optimal debulking (based on definitions of optimal cytoreduction at the time of the trials) and met the eligibility criteria for inclusion in IP vs IV chemotherapy clinical trials.…”

Advancing Equity in Cancer Clinical Trials: Lessons From the Evidence

“…4 In response, ASCO-Association of Community Cancer Centers recently published a joint research statement outlining recommendations for achieving equity, diversity, and inclusion (EDI) in CCTs. 5 The multifaceted nature of the recommendations addresses the complexity of the problem. These recommendations include education and training of the research teams to help them develop cross-cultural competencies, effective communication, and trustworthiness; routine evaluation of the site's performance and impact of the EDI goals; investment and engagement in programs, policies, and procedures that promote EDI and incorporate accountability mechanisms; inclusion of patients and communities as partners in the research process; investment in the hiring and development of a diverse workforce and programs that build capacity for supporting the enrollment of diverse populations in clinical trial research (such as navigators, ambassadors, and other clinical trial advocates); and finally, collection and sharing of EDI evidence and best practices.…”