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Minority recruitment trends in phase III prostate cancer clinical trials (2003-2014): progress and critical areas for improvement.

Journal of Urology 2018 September 13
PURPOSE: U.S. minority groups have been historically underrepresented in phase III prostate cancer clinical trials despite often having higher risk disease. This study analyzes enrollment trends of major U.S. racial/ethnic groups in phase III prostate cancer trials between 2003-2014 compared to Surveillance, Epidemiology, and End Results (SEER) incidence data.

MATERIALS AND METHODS: Phase III prostate cancer trials primarily enrolling patients from the U.S. were identified in the ClinicalTrials.gov database. Enrollment trends were analyzed for major racial/ethnic groups. Prostate cancer incidence data from the SEER registry was used to identify enrollment targets. The enrollment difference was determined by calculating the absolute difference between the percentage of a racial/ethnic subgroup in the SEER registry population and the percentage of that subgroup in the phase III prostate cancer trial population.

RESULTS: Among 39 studies identified, African American enrollment in therapeutic trials increased across the study period (p<0.001). The enrollment difference for African Americans was -9.0% (95% CI, -7.6 to -10.5; p<0.001) in 2003-05 and 1.4% (95% CI, 0.2 to 2.6; p = 0.020) in 2012-14. However, African American men were under-enrolled in metastatic disease trials (enrollment difference = -5.8%; 95% CI, -4.8 to -6.8; p<0.001). Latino and Asian American men were consistently under-enrolled in all trial types.

CONCLUSIONS: U.S. minority groups were largely under-enrolled in phase III prostate cancer trials between 2003-2014. While recruitment efforts may have had an impact, as demonstrated by increased enrollment of African American men, there remains a need to expand recruitment efforts to achieve diversity in trials.

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