US Cancer Centers of Excellence Coordination of Operational Strategies Contribute to Enhanced Accrual of Racial and Ethnic Minorities in Clinical Trials
Regnante JM, Richie NA, Fashoyin-Aje L, Lee Hall L, Highsmith Q, Louis JA, Turner K, Hoover SC, Lee SC, Williams EL, Adams H, Obasaju C, Sargeant I, Geday M, Gandee M, Watson R, and Chen MS. US Cancer Centers of Excellence Coordination of Operational Strategies Contribute to Enhanced Accrual of Racial and Ethnic Minorities in Clinical Trials. Cancer Res 2019; 79(13).
Background: Racial and ethnic minority groups (REMGs) have low rates of inclusion in cancer trials. With the rise of precision medicine, it is critical that study populations in clinical research reflect the changing US demographics. 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 identified cancer centers to ascertain operational strategies contributing to enhanced accrual of REMGs. Results: Eight representative centers reported a REMG accrual rate range in cancer research between 10-50% in a 12-month reporting period and met other criteria for inclusion, and 14 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 improving accrual. There was also a commitment to establish processes that support the patient's provider as the key influencer of patient recruitment into clinical trials. Conclusion: Conduct of cancer research requires coordination of an operational framework governed by metrics in order to achieve high accrual of diverse populations in clinical trials. Leading US cancer centers have established key Operational Excellence practices and other notable practices which are critical for optimizing sustained inclusion of diverse populations in cancer clinical research.