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Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006-2020.

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Title: Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006-2020.
Authors: Lythgoe, MP
Krell, J
Savage, P
Prasad, V
Item Type: Journal Article
Abstract: BACKGROUND: There is significant racial disparity in prostate cancer (PCa) in terms of incidence, treatment, and outcomes. Racial diversity and compliance with FDA race reporting guidelines in PCa drug registration trials are unknown. We analyzed racial diversity and race reporting in drug licensing trials for PCa. METHODS: New drug authorizations for PCa from 2006 to 2020 were identified. The corresponding licensing trial publications were analyzed to check compliance with current FDA recommendations for race reporting. If race was unreported, the clinical trial report was analyzed to determine participant recruitment by race and lead the recruiting country. RESULTS: During the study period, 17 new drug registrations for the management of PCa involving ten unique drugs were identified. In total, 18,455 participants were included in FDA registration trials, of which 76.3% were white or Caucasian, 7.9% Asian, 2.9% Black or African American, 0.5% American Indian or Alaskan Native, 0.1% Native Hawaiian or other Pacific Islander, 1.8% other or multiple races and 10.5% unknown. 53% of trials reported race in the licensing publication, however of this only 55% met current FDA recommendations. When the race was unreported in the licensing publication, 88% of studies had further information in the clinical study report. CONCLUSION: We found a significant under-representation of non-white participants in FDA drug registration trials for PCa. Race reporting in licensing publication is inconsistent and both FDA and International Committee of Medical Journal Editors guidelines are not being universally followed. Given the disproportionality of the disease burden of PCa, recruitment of Black and other minority participants to trials should be a research priority.
Issue Date: 15-Apr-2021
Date of Acceptance: 23-Mar-2021
URI: http://hdl.handle.net/10044/1/88116
DOI: 10.1038/s41391-021-00361-0
ISSN: 1365-7852
Publisher: Springer Nature [academic journals on nature.com]
Start Page: 1208
End Page: 1211
Journal / Book Title: Prostate Cancer and Prostatic Diseases
Volume: 24
Copyright Statement: © The Author(s) 2021. This article is published with open access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Sponsor/Funder: Ovarian Cancer Action
Funder's Grant Number: n/a
Keywords: Science & Technology
Life Sciences & Biomedicine
Oncology
Urology & Nephrology
1112 Oncology and Carcinogenesis
Urology & Nephrology
Publication Status: Published
Conference Place: England
Open Access location: https://www.nature.com/articles/s41391-021-00361-0
Online Publication Date: 2021-04-15
Appears in Collections:Department of Surgery and Cancer
Faculty of Medicine



This item is licensed under a Creative Commons License Creative Commons