Diversity of Enrollment in Prostate Cancer Clinical Trials: Current Status and Future Directions.


Journal

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
ISSN: 1538-7755
Titre abrégé: Cancer Epidemiol Biomarkers Prev
Pays: United States
ID NLM: 9200608

Informations de publication

Date de publication:
07 2020
Historique:
received: 29 12 2019
revised: 03 03 2020
accepted: 07 04 2020
pubmed: 7 6 2020
medline: 16 9 2021
entrez: 7 6 2020
Statut: ppublish

Résumé

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. 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. 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. Trial participants continue to be majority white despite the known racial disparities in prostate cancer clinical outcomes. 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.

Sections du résumé

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.

Identifiants

pubmed: 32503813
pii: 1055-9965.EPI-19-1616
doi: 10.1158/1055-9965.EPI-19-1616
pmc: PMC7334076
mid: NIHMS1584946
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1374-1380

Subventions

Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NCI NIH HHS
ID : T32 CA009001
Pays : United States

Informations de copyright

©2020 American Association for Cancer Research.

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Auteurs

Emily M Rencsok (EM)

Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. emily_rencsok@hms.harvard.edu.
Harvard-MIT Division of Health Sciences and Technology, Harvard Medical School, Boston, Massachusetts.

Latifa A Bazzi (LA)

Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.

Rana R McKay (RR)

Department of Oncology, University of California San Diego Moores Cancer Center, La Jolla, California.

Franklin W Huang (FW)

Department of Hematology and Oncology, University of California San Francisco, San Francisco, California.

Adam Friedant (A)

Prostate Cancer Clinical Trials Consortium, New York, New York.

Jake Vinson (J)

Prostate Cancer Clinical Trials Consortium, New York, New York.

Samuel Peisch (S)

Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

Jelani C Zarif (JC)

Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Stacey Simmons (S)

Bayer Oncology, Whippany, New Jersey.

Kelly Hawthorne (K)

Movember Foundation, East Melbourne, Australia.

Paul Villanti (P)

Movember Foundation, East Melbourne, Australia.

Philip W Kantoff (PW)

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Elisabeth Heath (E)

Department of Oncology, Wayne State University Karmanos Cancer Institute, Detroit, Michigan.

Daniel J George (DJ)

Duke Cancer Institute, Durham, North Carolina.

Lorelei A Mucci (LA)

Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

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