Speakers
Gerald Bloomfield, MD, MPH
Associate Professor with Tenure, Medicine
Associate Professor, Global Health
Duke University School of Medicine
Michelle Kelsey, MD
Assistant Professor of Medicine
Duke University School of Medicine
Keywords
Diversity, Inclusion
Key Points
- There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. population at large, which is steadily becoming more diverse.
- The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research. It was held virtually on April 28-29, 2021. Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others.
- Three key themes emerged from the Think Tank discussion: build partnerships with participants and communities; improve accessibility of clinical trials; improve representation among clinical investigators.
- For the theme of building partnerships, community engagement was identified as particularly effective for recruitment of racial and ethnic minority groups. In systematic reviews, community involvement and partnership with community-based organizations are universally cited as key to success. Communities should be involved from the very beginning where both the community and investigators take ownership of the research and are equally involved and interested.
- For the theme of improving the accessibility of clinical trials, the Think Tank identified steps such as decentralizing clinical trials to reduce geographic barriers, using digital tools, and leveraging community infrastructure already in place to improve accessibility to clinical trials.
- For the theme of improving representation and diversity among clinical investigators, having a more representative clinical trial workforce might translate to more diverse participants. We have seen that having a higher proportion of women authors resulted in a higher proportion of women enrolled per trial. To prioritize diversity in the clinical research workforce, institutions should hire individuals from under-represented groups and offer support and mentorship of their research endeavors.
Discussion Themes
-Is there low hanging fruit we should encourage people to focus on? Where to start? This is an issue that a number of institutions have been thinking about for some time. We have made tremendous progress with some of the programs that Michelle alluded to, programs that are developing a pipeline of researchers. In terms of untapped potential, the engagement with the community, taking the time to identify who folks are and speak face to face. Ask questions like here’s what we think are priorities; are we right? Ask and engage community partners.
–How do investigators target rural areas to increase diversity? This is one of the biggest gaps that we do not have a solution for yet in the clinical trial space. NIH has done a lot with epidemiological research to reach, engage, understand rural populations. The face-to-face component, the time in front of individuals is a critical step to being welcomed and to engaging people in rural settings.
Learn more
Read about the DCRI Think Tank results: Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.
Tags
#pctGR, @Collaboratory1