Innovative Solutions for Improving Diversity in Clinical Trials

USC has received $5.8 million from Gates Ventures and the American Heart Association to launch a lab aimed at diversifying clinical trials.

The program, which will target Alzheimer’s disease initially, will test ways to accelerate clinical trial development and increase participation from underserved groups in studies of new therapies and potential cures. The San Diego USC Alzheimer's Therapeutic Research Institute (ATRI) and USC Schaeffer Center for Health Policy & Economics in Los Angeles will spearhead the new Clinical Trial Recruitment Lab (CTRL).

“CTRL will improve multiple aspects of the trial screening process, moving us toward representative populations for the rigorous evaluation of new therapies.  This work will be enhanced  by bringing together an interdisciplinary group of stakeholders from the public and private sectors,” said Paul Aisen, director of the ATRI.

The Clinical Trial Recruitment Lab, or CTRL, will be led by Aisen and Dana Goldman, dean of the USC Price School of Public Policy and co-director of the Schaeffer Center; and Rema Raman, ATRI director of biostatistics and the co-lead of the Recruitment Unit for the Alzheimer’s Clinical Trials Consortium (ACTC).

CTRL will launch pilot studies to test innovative, scalable strategies that minimize barriers which prevent patients from accessing clinical trials. For example, one pilot study will work with Quest Diagnostics and other labs that have locations throughout the U.S. Trial volunteers will be able to receive testing for blood-based markers of Alzheimer’s locally instead of having to travel to a clinical trial site.

A key feature of the project will be a fellowship program in partnership with Howard University’s Department of Economics aimed at training a new generation of clinical trial experts. The project also will look for strategies to minimize barriers that prevent patients from accessing clinical trials, and creatively disseminate findings and best practices among stakeholders from industry, research and philanthropy.

“We suffer from two interconnected issues: the slow pace of trials and a lack of diversity,” said Goldman. “The Clinical Trial Recruitment Lab will address both these issues and potentially transform pharmaceutical and medical device development.”

Added Raman: “Including diverse participants in clinical trials will result in findings that can be more accurately generalized to reflect the overall Alzheimer’s patient population at risk.”

By 2050, the number of Americans over age 65 with AD is projected to increase to 13.8 million, more than double the population today. Currently, just 1% of eligible patients are enrolled in clinical trials for potential AD therapies. Targeted outreach is especially crucial, as Black and Hispanic populations have higher rates of dementia than whites but are frequently underrepresented in trial populations. 

The Lab will bring together an interdisciplinary team of researchers to lead and advise the pilot projects including Jevay Grooms of Howard University and the USC Price School of Public Policy; Jessica Ho and Mireille Jacobson of the USC Leonard Davis School of Gerontology and the Schaeffer Center; Cecily Jenkins and Doris P. Molina-Henry of the Keck School of Medicine of USC; Thomas Obisesan of Howard University; Sarah Walter of USC ATRI; and Julie Zissimopoulos of the Price School of Public Policy and the Schaeffer Center.