17 min listen
What We Are Missing by Not Including ”Who?”
What We Are Missing by Not Including ”Who?”
ratings:
Length:
13 minutes
Released:
Jun 30, 2022
Format:
Podcast episode
Description
In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all contributed, but this draft was led by Project Equity from FDA’s Oncology Center of Excellence (OCE). “It is important that we be able to evaluate new therapies in the context of a diverse population that will use these medical products because the diseases for which these products are intended present in variable fashion across the population and because populations respond variably to medical products,” explains OCE Project Equity Lead Lola Fashoyin-Aje. “But we should reconsider the question regarding why diversity in clinical trials is important. Because the question really ought to be: What are we missing when trials are not diverse, when the study population in the clinical trial is not diverse? What are the missed opportunities for advancing science or advancing clinical medicine and, ultimately, for driving improvements in population outcomes?”
Released:
Jun 30, 2022
Format:
Podcast episode
Titles in the series (20)
China Sets New Record for Local Drug Approvals in 2021: DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs an... by DIA: Driving Insights to Action