Diversity in Clinical Trials Starts with Diversifying Research Staff

A key topic at many clinical research and scientific conferences is the need to increase diversity and inclusion among clinical trial participants. Indeed, the FDA issued draft guidance earlier this year to help increase enrollment of patients from underrepresented racial and ethnic communities.

Increasingly, there is a recognition that diversity and inclusion efforts must also include attention on staffing, from research coordinators to principal investigators.

Diversity among research staff has implications for diversity in research. UCSF’s professor of bioengineering Esteban Burchard, MD, MPH, notes that it was only when more women became involved in cardiovascular research that the medical community become aware that their biology is different from men, and you could not generalize study results in men to women. Women needed a different approach to treatment of cardiovascular disease.

In a recent article in Nature, UCSF health equity researcher Tung Nguyen outlined steps that his institution has taken to diversify biomedical research. Prof. Nguyen, associate vice-chancellor for research inclusion, diversity, equity and anti-racism at University of California, San Francisco (UCSF), outlines the work his task force has done to ensure that study subject recruitment is inclusive.  One area they are addressing is how to proactively diversify clinical research staff.

The Tufts Center for the Study of Drug Development at Tufts University School of Medicine reported that a key factor in enrolling diverse patients is having diverse staff working at the investigative site. Their research shows that sites with higher racial and ethnic diversity tended to have higher diversity among patients enrolled in clinical trials.

According to Kenneth Getz, director of the center and a research professor at the Tufts School of Medicine, who led the study, said, “The results of this robust study unequivocally show a very strong correlation.”

Several research institutions are examining ways to develop and support diversity among researchers and staff. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard has published a downloadable document entitled “Achieving Inclusion, Diversity and Equity in Clinical Research.” Among the recommendations are workforce development, including efforts to diversify the workforce, as well as training in implicit bias and cultural competence of the current workforce.

“A clinical research workforce that is diverse itself is better able to prioritize, connect, care for, and successfully recruit a diverse participant population in research,” according to the document’s authors.

Have an honest look

Diversity researchers encourage leaders to audit their own organizational cultures. Ask yourself who holds the power and who does not, and what the impact may be. Identifying internal inequities is the start of honest conversations.

Support mentorship initiatives

Earlier this year, Mayo Clinic awarded their “Diversity in Clinical Trials Career Development Award” to six researchers and physicians. According to Mayo Clinic, “the two-year program aims to train, develop and mentor diverse and community-oriented researchers and physicians to help increase the diversity of patients enrolled in clinical trials, and ultimately to enhance the development of therapeutics for all populations.”

Engage local organizations and institutions

To build trust and rapport with diverse communities, institutions must understand their backgrounds and cultures. Partnering with community groups can be an effective strategy in building these important relationships. For example, UCSF recruited trainees from San Francisco State University, known for its active engagement in the Hispanic community.

Reach beyond hiring exclusively based on experience

Relying exclusively on traditional experience-based indicators runs the risk of overlooking candidates who have skills to do the job even if they lack hands-on experience.

Online learning opportunities for professionals, such as clinical research coordinators, gives new hires foundational knowledge of regulatory requirements, ethics, and human subject protection.

Promote transparency

Various guidance documents recommend that institutions make public statements regarding their commitment to inclusion and diversity. UCSF publishes regular reports and dashboards about its diversity and inclusion efforts and results.

Employing research staff who share demographic and cultural characteristics with the study population may add acceptability and relevance to the research and to the community.

The NIH has a downloadable “Scientific Workforce Diversity Toolkit,” and evidence-based tool to address workforce diversity and inclusion, focusing not only on hiring a diverse workforce but also supporting individuals who are currently in the workforce. The NIH Toolkit includes a recruitment tool that institutions can use to expand their candidate pool to include more diverse talent, address bias in the search process, and provide guidance on and methods for outreach, networking, and mentoring relationships.