Pediatrics | 2021
Advocating for Minority Inclusion in Clinical Trials: A Call for Representation and Justice
Abstract
Off-label prescribing of medications has been a long-standing practice in pediatric medicine because, in the types of studies regarding safety, efficacy, and pharmacokinetics needed for labeling, researchers often only enroll adult subjects. The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act have significantly increased the number of pediatric trials submitted to the US Food and Drug Administration for drug labeling in the past 10 years. Prioritizing minority enrollment in BPCA-funded clinical trials will increase the generalizability of scientific findings within the broader pediatric population.