Operational strategies in US cancer centers of excellence that support the successful accrual of racial and ethnic minorities in clinical trials

Abstract

Background: Study populations in clinical research must reflect US changing demographics, especially with the rise of precision medicine. However, racial and ethnic minority groups (REMGs) have low rates of participation in cancer clinical trials. Methods: Criteria were developed to identify cancer centers able to accrue a higher than average proportion of REMGs into clinical trials. Comprehensive interviews were conducted with leaders of these cancer centers to identify operational strategies contributing to enhanced accrual of REMGs. Results: Eight US cancer centers reported a REMG accrual rate range in cancer research between 10 and 50% in a 12-month reporting period and met other criteria for inclusion. Fourteen leaders participated in this assessment. Key findings were that centers: had a metric collection and reporting approach; routinely captured race and ethnicity data within databases accessible to research staff; had operational standards to support access and inclusion; developed practices to facilitate sustained patient participation during clinical trials; had strategies to decrease recruitment time and optimize clinical study design; and identified low-resource strategies for REMG accrual. There was also a clear commitment to establish processes that support the patient's provider as the key influencer of patient recruitment into clinical trials. Conclusion: We have identified operational practices that facilitate increased inclusion of REMGs in cancer trials. In order to establish a sustainable cancer center inclusion research strategy, it is valuable to include an operational framework that is informed by leading US cancer centers of excellence. Keywords: Cancer research, Clinical trials, Operations, Disparities, Diversity and inclusion, Racial and ethnic minority groups