The Representative Studies Rubric: A Tool for Diversity in Clinical Trials.

Abstract

When clinical trials fail to enroll diverse study populations, a multitude of consequences can occur, including compromised validity and generalizability, safety and efficacy uncertainties, regulatory limitations, widened disparities, distrust in science and medicine, and undermined efforts to address urgent health needs. We developed the Representative Studies Rubric (RSR), a questionnaire that evaluates the extent to which clinical trials are designed to enroll representative study populations with a focus on age, ethnicity, drug use, gender, pregnancy, race, and sex assigned at birth. We used the RSR to conduct an analysis of all active studies in the NIH-funded HIV/AIDS Clinical Trials Networks (Networks) and identified patterns of research practices that may limit the participation of underrepresented populations, with ethical implications. The Networks subsequently formalized the RSR as a required protocol development tool for all future studies to correct exclusionary research practices with the goal to achieve more representative study populations.