Increasing Diversity in Clinical Trials: Overcoming Critical Barriers

Luther T. Clark, Laurence Watkins, Ileana L. Piña, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, Cassandra McCullough, Christine Pierre, Adam B. Polis, Gary Puckrein, Jeanne M. Regnante

Research output: Contribution to journalReview articlepeer-review

307 Scopus citations


Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients’ willingness to participate in trials and—based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators—formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.

Original languageEnglish (US)
Pages (from-to)148-172
Number of pages25
JournalCurrent Problems in Cardiology
Issue number5
StatePublished - May 2019

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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