FDA to discuss demographic data

FDA will hold a public meeting on April 1 to obtain stakeholder input on the issues and challenges with collecting, analyzing and making available demographic subgroup data in applications for FDA approval of medical products. The agency is seeking input on topics including enrolling subgroup populations proportionate to disease prevalence; statistical challenges when analyzing trial data for subgroup differences; and what demographic information is helpful to researchers, patients and doctors. FDA plans to incorporate stakeholder input into an action plan the agency is developing. The agency is accepting comments until May 16. ...