The DRIVE Initiative

D.R.I.V.E. is our strategic framework for promoting representative enrollment in clinical trials. This initiative addresses the inherent safety and efficacy concerns that arise when studies are conducted in populations that do not reflect the different patient groups these treatments are intended to serve. Generalizability, the ability to infer treatment effects for the entire population from a study population, and transportability, the ability to apply treatment effects from one group to another, are critical for ensuring equitable and effective care. To uphold these principles, we define “clinical trial excellence” as studies that successfully meet these diversity and representation benchmarks.

Despite growing awareness of these issues, most clinical trials remain unrepresentative, leading to data gaps that disproportionately impact minoritized populations. Historical migration patterns, systemic inequities, and biological factors such as genetic polymorphisms and microbiome diversity all contribute to varied treatment responses among different racial and ethnic groups. However, current trial designs often fail to account for these differences, resulting in regulatory approvals based on non-generalizable data. The D.R.I.V.E. Initiative 2025 aims to establish measurable standards for representation, advocate for policy changes, and promote inclusive research practices that improve clinical outcomes for all patients, regardless of background.