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

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

SUBMITTER: Lythgoe MP 

PROVIDER: S-EPMC8616766 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature