The US Food and Drug Administration (FDA) has released updated draft guidance aimed at enhancing diversity in clinical trials. This comprehensive diversity guidance is expected to improve clinical trial results, yield a better understanding of treatment effects, and increase trust and participation among underrepresented groups. The guidance suggests that sponsors may need to overenroll key groups to ensure diverse representation. The FDA's medical policy chief emphasized the importance of decentralized trials and improving diversity. The initiative is part of a broader effort to enhance clinical trials through stakeholder collaboration, focusing on efficiency, diversity, and regulatory frameworks. Additionally, the National Institutes of Health (NIH) has launched the CARE for Health program, further supporting these efforts. The US_FDA Diversity action plan document is now live.
Below is from Janet Woodcock's (FDA Principal Deputy Commissioner at the time) presentation at USCF/Stanford summit in '21 lamenting poorly designed clinical trials. cc @llborio https://t.co/mmAhe74wkg
FDA publishes updated draft guidance on #clinicaltrialdiversity https://t.co/otlY7vil4d Too many approved to products don't work for some of the groups that are most disadvantaged in the health care system. #patientsfirst @BiotechCH @IAmBiotech
(1/2) Our 2-story package on the clinical trial diversity plan guidance. Story 1 is on the plan requirements @PinkSheetSutter ... @PharmaPinkSheet #pinksheet #pharma: Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says https://t.co/Y8qkSzUiwP
Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups https://t.co/yVGh0Fse6O #PinkSheet
Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups :: Pink Sheet https://t.co/5x2anSbOxe
An interesting First Opinion on FDA's diversity guidance plan. In reporting on this, i've found that science is still grappling with even defining diversity. Getting all the parts, from cultural competence to trust building, is difficult https://t.co/WsRkyeJwn2 via @statnews
Enhancing Clinical Trials: A Collaborative Approach for Better Patient Outcomes Enhancing clinical trials through stakeholder collaboration, focusing on improving efficiency, diversity, and regulatory frameworks. This initiative aims to advance the speed and quality of… https://t.co/cLp4wVWOuJ
Huge annoucements at @WHOSTP #clinicaltrialsforum w/@NIHDirector @FDACommissioner and patient advocate #sandrabishop - Clinical trials ARE the standard of care for many cancers. - @US_FDA Diversity action plan doc is LIVE -@NIH CARE for Health has been launched https://t.co/gSvicxhlSU https://t.co/9KM1DuPlYl
Comprehensive diversity guidance will improve clinical trial results, yield a better understanding of treatment effects, and increase trust and participation among underrepresented groups. https://t.co/Isw9Rhjkq3
Q&A: FDA medical policy chief talks decentralized trial guidance, improving diversity https://t.co/umgZXQp1aq #biotech #news