Impact of Global Enrollment on Race, Ethnicity, and Age Representation in Pivotal Gynecologic Cancer Trials Leading to US Food and Drug Administration Drug Approvals

Impact of Global Enrollment on Race, Ethnicity, and Age Representation in Pivotal Gynecologic Cancer Trials Leading to US Food and Drug Administration Drug Approvals

PURPOSETo evaluate the impact of international enrollment in landmark gynecologic cancer (Gyn-Ca) trials that supported the US Food and Drug Administration (FDA) drug approvals.METHODSWe examined the FDA drug approval database for approved Gyn-Ca agents between January 2014 and June 2024. We then ex...

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Main Authors: Maheen H. Khan, Kristen R. Ibanez, Courtney Bowen, Duncan Donohue, Ann Oluloro, Elizabeth M. Swisher, Jung-Min Lee
Format: Article
Language:English
Published: American Society of Clinical Oncology 2025-05-01
Series:JCO Global Oncology
Online Access:https://ascopubs.org/doi/10.1200/GO-24-00636
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