by Lisa Green
Broader inclusion of diverse populations in clinical trials has been a topic of conversation for several years, as there are significant disparities in representation of age, race, socio-economic status and gender in historical clinical trial design. Now, the COVID pandemic has put an even greater public lens on how clinical trials are run and what populations are represented. There is increased urgency to conduct trials in more realistic participant pools, especially for conditions that disproportionately affect different populations.
In the ‘Perspectives on Clinical Trial Diversity’ session at SXSW 2021, the panelists argued that the reasons for lack of diversity can be due to many factors. Mistrust of the medical establishment among many portions of society, not just in minority populations, is a key barrier to diversity in clinical trials, and many populations lack education on the trial process or awareness on particular studies. Participant burden due to logistical requirements of trials for monitoring and follow-up can also limit clinical trial diversity. Historically, medical school training has a bias regarding gender; women have been under-represented in trials due to concerns around experimental agents and fetal-embryo harm, or potential complication of results due to women’s hormonal cycles. Results seen in men were extrapolated to women, but this does not reflect accurate assessment of how interventions can specifically affect functions of female biology.
There are several innovative approaches that Institutions and pharmaceutical companies can employ to increase clinical trial diversity. Community-based partnerships with local health providers or women’s health centers can help build trust. Creating stakeholder engagement early on to raise awareness is also effective, as is including trial investigators from multiple backgrounds. Electronic health systems or patient portals— e.g., My Chart—can be used for direct outreach to potential participants. And importantly, transparency and honesty about past failings, lessons learned and how these experiences are being used to broaden clinical trial diversity are key.
- Aisha Langford · NYU Grossman School of Medicine
- Maya Dusenbery · Self Employed, author of “Doing Harm”
- Richard Campbell · Bristol Myers Squibb