FDA vows more sex & other subgroup diversity
This article was originally published in Scrip
Executive Summary
In response to a congressional mandate – and years of criticism – the FDA on 20 August committed to taking 27 actions aimed at improving the completeness and quality of demographic subgroup data collected, reported and analyzed by drug makers; identifying barriers for enrolling diverse populations in clinical trials and employing strategies to encourage greater participation; and making subgroup data more transparent and available to the public.