TY - JOUR
T1 - Diversity of enrollment in prostate cancer clinical trials
T2 - current status and future directions
AU - Rencsok, Emily M.
AU - Bazzi, Latifa A.
AU - McKay, Rana R.
AU - Huang, Franklin W.
AU - Friedant, Adam
AU - Vinson, Jake
AU - Peisch, Samuel
AU - Zarif, Jelani C.
AU - Simmons, Stacey
AU - Hawthorne, Kelly
AU - Villanti, Paul
AU - Kantoff, Philip W.
AU - Heath, Elisabeth
AU - George, Daniel J.
AU - Mucci, Lorelei A.
N1 - Funding Information:
E.M. Rencsok was supported by T32CA009001. R.R. McKay, F.W. Huang, J.C. Zarif, and L.A. Mucci are Young Investigators of the Prostate Cancer Foundation. The authors additionally acknowledge all clinical trial authors for their correspondence regarding race/ethnicity data that have not been published. This project was supported in part by the Movember Foundation and T32CA009001.
Publisher Copyright:
© 2020 American Association for Cancer Research.
PY - 2020/7
Y1 - 2020/7
N2 - Background: Although there are considerable racial and ethnic disparities in prostate cancer incidence and mortality in the United States and globally, clinical trials often do not reflect disease incidence across racial and ethnic subgroups. This study aims to comprehensively review the reporting of race and ethnicity data and the representation of race and ethnicity across prostate cancer treatment-, prevention-, and screening-based clinical trials. Methods: Seventy-two global phase III and IV prevention, screening, and treatment prostate cancer clinical trials with enrollment start dates between 1987 and 2016 were analyzed in this study, representing a total of 893,378 individual trial participants. Availability and representation of race and ethnicity data by trial funding type, temporal changes in the racial/ethnic diversity of participants, and geographic representation of countries were assessed. Results: Of the 72 trials analyzed, 59 (81.9%) had available race data, and 11 (15.3%) of these trials additionally reported ethnicity. Of the trials reporting data, participants were overwhelmingly white men (with the highest proportion in U.S. nonpublicly funded trials), comprising over 96% of the study population. The proportion of white participants in prostate cancer clinical trials has remained at over 80% since 1990. Geographically, Africa and the Caribbean were particularly underrepresented with only 3% of countries included. Conclusions: Trial participants continue to be majority white despite the known racial disparities in prostate cancer clinical outcomes. Impact: Current and future trials must use novel recruitment strategies to ensure enrollment of underrepresented men. Targeting the inclusion of African and Caribbean medical centers is crucial to achieve equity in representation.
AB - Background: Although there are considerable racial and ethnic disparities in prostate cancer incidence and mortality in the United States and globally, clinical trials often do not reflect disease incidence across racial and ethnic subgroups. This study aims to comprehensively review the reporting of race and ethnicity data and the representation of race and ethnicity across prostate cancer treatment-, prevention-, and screening-based clinical trials. Methods: Seventy-two global phase III and IV prevention, screening, and treatment prostate cancer clinical trials with enrollment start dates between 1987 and 2016 were analyzed in this study, representing a total of 893,378 individual trial participants. Availability and representation of race and ethnicity data by trial funding type, temporal changes in the racial/ethnic diversity of participants, and geographic representation of countries were assessed. Results: Of the 72 trials analyzed, 59 (81.9%) had available race data, and 11 (15.3%) of these trials additionally reported ethnicity. Of the trials reporting data, participants were overwhelmingly white men (with the highest proportion in U.S. nonpublicly funded trials), comprising over 96% of the study population. The proportion of white participants in prostate cancer clinical trials has remained at over 80% since 1990. Geographically, Africa and the Caribbean were particularly underrepresented with only 3% of countries included. Conclusions: Trial participants continue to be majority white despite the known racial disparities in prostate cancer clinical outcomes. Impact: Current and future trials must use novel recruitment strategies to ensure enrollment of underrepresented men. Targeting the inclusion of African and Caribbean medical centers is crucial to achieve equity in representation.
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U2 - 10.1158/1055-9965.EPI-19-1616
DO - 10.1158/1055-9965.EPI-19-1616
M3 - Article
C2 - 32503813
AN - SCOPUS:85087530437
SN - 1055-9965
VL - 29
SP - 1374
EP - 1380
JO - Cancer Epidemiology Biomarkers and Prevention
JF - Cancer Epidemiology Biomarkers and Prevention
IS - 7
ER -