Insufficient diversity in clinical trials and other research cohorts is widely recognized as one of American health care’s greatest problems and one that continues to skew scientific data and conclusions in ways that disadvantage enormous numbers of people.
It’s a problem that has been the subject of endless national discussions, debate, investigations, analysis, and general wheel-spinning throughout the highest levels of the health care policy community.
A March 2022 article in Health Affairs detailed a postmortem on a five-year-long Food and Drug Administration (FDA) “action program” aimed at improving diversity and transparency in clinical trials for new drugs. The authors reported that they “failed to find evidence that the FDA action plan improved representation of Black trial participants.”
It is against this general background that in 2021, two closely affiliated University of Pennsylvania research centers—the Palliative and Advanced Illness Research Center (PAIR) and the Center for Health Incentives and Behavioral Economics (CHIBE)—launched their own effort to find ways to increase diversity within their organizations’ clinical trials and other research studies.
“Many events in 2020 and 2021 galvanized renewed energy within our organization around long-standing social injustices,” says PAIR director and LDI senior fellow Scott Halpern. “Many of our researchers and staff were actively looking for ways to respond and recognized the need for greater emphasis on justice and inclusion in our own research processes. We quickly realized that charging a group to lead the way in producing guidance for equitable research practices would enable us all to learn from them, and best accomplish our shared goals.”
This resulted in the creation of the Joint Research Practices (JRP) Working Group.
“The goal of the JRP was to identify best practices and produce guidelines for the incorporation of equity, inclusion, and access across the arc of the research process,” says Rachel Kohn, co-lead of the JRP and LDI senior fellow. “Initially, we reached out to peer institutions to see if anyone was working on something similar. But we found that even in places where there was a lot of work being done surrounding health equity and social justice, there was no group working on identifying the fundamental methodology and practices that could be used for making specific parts of the research process more diversified, equitable, and accessible by underrepresented populations.”
The JRP guidelines and best practices documents focus on the major obstacles that make the recruitment and retention of subjects from underrepresented communities so difficult—language barriers, social disadvantage, money, and the personal trust that evolves out of eliminating these barriers effectively. The guidelines cover participant payment and incentive, language interpretation and translation, plain language in research communications, readability of study materials, and inclusive language for scientific communications.
Read more at Penn LDI.
