Robert H. Goldstein, M.D., Ph.D., and Rochelle P. Walensky, M.D., M.P.H. explain what happened with the Gilead Sciences DISCOVER trial and why it failed cisgender women and people everywhere.
From the article:
"Two months after its approval for treatment, F/TAF’s manufacturer, Gilead Sciences, moved forward with an effort to expand the drug’s indications to include prevention of HIV infection. To do so, they collaborated with researchers, community members, and the FDA to develop a new preexposure prophylaxis trial protocol — the DISCOVER trial — and to work toward a supplemental new drug application for F/TAF.
The trial specifically excluded cisgender women because of perceived challenges in enrollment and concern about reaching a meaningful end point. DISCOVER was registered with and posted to ClinicalTrials.gov (NCT02842086. opens in new tab) in June 2016.
Clinical trial design requires diverse voices and intentional inclusion criteria. It is up to human-subjects committees to maintain vigilant oversight of study protocols with these FDA standards in mind, regardless of whether the studies in question are industry-sponsored. And when the FDA is presented with data that exclude half the world’s population, it can use the tools at its disposal to address the violation."