FDA addresses health disparities in final guidance on clinical trial diversity 

FDA released on Monday its final guidance on enhancing diversity in clinical trials with recommendations to reduce underrepresentation including adaptive study designs, targeted population enrollment and broadened inclusion criteria.

Though the guidance has been in the works for a while, the final version comes at a time when biopharma companies are more aware than ever of the need to create greater diversity in clinical trials, in the wake of COVID-19 data showing grossly disproportionate outcomes among Black and other minority ethnic groups. But the disparities extend to many other disease areas...