Guidance Document Includes Tips for Making Clinical Research More Inclusive

By Jonathan Springston, Editor, Relias Media

The Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women’s Hospital and Harvard has released a detailed document that includes education on making clinical trial research more diverse, inclusive, and equitable.

Achieving Diversity, Inclusion, and Equity in Clinical Research defines these concepts, explains the importance of these goals, identifies the barriers, and includes tips for how to achieve diversity in participant populations.

“Clinical research, and the lack of appropriate representation, is an integral component of the problem. Change and corrective action are challenging and will only occur with the commitment of the entire clinical research enterprise,” Barbara Bierer, MD, faculty director of the MRCT Center, said in a statement. “This work is necessary, but not easy, and will take time to achieve meaningful change. We appreciate that the guidance is a living document, one that will grow as experience and considered analyses inform successful approaches.”

The August issue of IRB Advisor contains three articles on the topic of diversity in clinical research. The cover story is about the lack of minority inclusion in trials, along with information on why this is a problem and barriers to overcome. Contributing factors to the disparity include diseases that affect African Americans disproportionately, such as hypertension, kidney disease, heart disease, and diabetes. Other factors relate to disparities in income, employment, housing, educational opportunities, transportation, and incarceration.

“COVID-19 disproportionately affects people of color in the United States. Can we use the awareness of the disproportionate impact of COVID-19 and the need for research representation to bring awareness to the larger issue of ensuring diversity in all clinical research,” asked Edith Mitchell, MD, director of the Center to Eliminate Cancer Disparities.

Importantly, as noted in this August IRB Advisor article, diversity and inclusion go beyond race and ethnicity. For instance, researchers found poor representation among those with inadequate access to medical care, with an annual household income below 200% of the federal poverty line, who live in rural or nonmetropolitan areas, with less than a high school education or equivalent, with cognitive or physical disabilities, and who are intersex or identify as a sexual minority.

Finally, as explained in this article, The Children’s Oncology Group, which represents more than 200 institutions worldwide, has helped enroll thousands of children, adolescents, and young adults in a single trial at a variety of sites. The idea is that if the barrier is a simple lack of institutional resources, then perhaps several facilities in one area could pool their resources to help not only grow the size of a clinical trial population, but also make it more diverse and inclusive.