14 Tactics to Improve Clinical Trial DiversityWe did 100 hours of stakeholder interviews so you don't have to
100+Hours of interviews
14,000+Clinical Trials
100+Literature Reviews
Quita Beeler Highsmith, M.B.A. preview

Quita Beeler Highsmith, M.B.A.

Chief Diversity Officer at Genentech

Rodrigo Garcia, M.D., M.S.H.S. preview

Rodrigo Garcia, M.D., M.S.H.S.

Vice President of Sites and Patient Center of Excellence at PPD

Lloryn Hubbard preview

Lloryn Hubbard

Director of Patient Diversity at PPD

Kenneth Mahaffey, M.D. preview

Kenneth Mahaffey, M.D.

Professor and Vice Chair of Clinical Research, Stanford University

WHY NOW?

Currently, non-white groups comprise 36% of the total US population but only 15-20% of clinical trial participants collectively. Across research, racial and ethnic minorities are <2x underrepresented. The vast majority of literature quantifies the depth of the problem and its root causes, without much discussion of how individual players can change the status quo.
We noticed an opportunity to go beyond the analysis and collect the tactical solutions that are being implemented today. Individual companies, sites, and researchers are making progress on an independent scale – the next step is to spread those efforts across the industry.

THE WHITE PAPER

We split the tactics into 5 lenses, grouped by granularity, from individual site-level opportunities to industry-wide topics. For each lens, we break down historic structural barriers and propose tactical solutions with real examples being implemented by researchers today.
Here are the 5 lenses:
1. Recruitment strategies and participant outreach. How we find and engage representative participants around existing sites.
2. Site personnel and operations. How we hire and train site staff to lead the charge on diverse recruitment.
3. Site selection. How we find, select, and manage research sites to support diverse participants.
4. Trial protocol design. How we identify historically exclusionary criteria and make protocol amendments to improve accessibility.
5. Regulation and economic incentives. How industry-wide incentive structures can influence change at scale.

WHO IS THIS WHITE PAPER FOR?

If you work in or around clinical research and strive to improve representation in trials, this White Paper is for you. Strategies and solutions encompass every level of trial rollout, from protocol design to site operations and recruitment.