BIO Submits Comments on FDA's Action Plan for Collection, Analysis, and Availability of Subgroup Data

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.

BIO member companies strive to conduct efficient, informative clinical trials to define the safety and efficacy of investigational therapies for all relevant populations. Sponsors are prioritizing the enrollment and analysis of relevant subpopulations in their clinical development programs and take seriously their obligations outlined in the Code of Federal Regulations to present safety and effectiveness data “by gender, age, and racial subgroups,” as well as for “other subgroups of the population of patients treated.”1 In addition to these regulatory requirements, BIO member companies have developed and employed proactive strategies to promote enrollment from relevant subpopulations that are traditionally under-represented in clinical trials.