FDA clinical trial inclusivity guidelines will be back As I’ve seen firsthand in my work with the agency, they are necessary

https://www.statnews.com/2025/02/06/fda-diversity-action-plan-guidelines-clinical-trials-inclusivity-rules/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9-bzTLjnVb_AcY9EKdBmT1AicTwyUZGDDTSBExKBXELoZP6Z-j9J2mmwhJNsy0gNMYYZaEFJb-Anc1CMHrdtCWzF5Cyg&_hsmi=346170968&utm_content=346170968&utm_source=hs_email First Opinion: Inclusive clinical trials are imperative If you tried to click on the main website for the Food and Drug Administration’s Diversity Action Plan guidelines in the past few weeks, you’d hit this: “Page Not Found.” It’s just one of many government sites that have gone down in recent days, some because of a Trump Executive Order banning diversity, equity and inclusion efforts. The guidelines were set forth in 2022, and enacted by Congress in recognition of the need to improve diversity in clinical trials. And, in a First Opinion essay, former FDA collaborator Suzanne B. Robotti predicts the plan will come back to life — out of necessity. “The trials we looked at were overwhelmingly populated by white men,” writes Robotti, who has been on over 20 FDA drug advisory committees and other panels. When they’re not inclusive, trials become less useful, because medications may fail to address the unique needs of all patient subgroups.