Under 2022’s Food and Drug Omnibus Reform Act, clinical trial sponsors are required to submit diversity action plans with pivotal drug studies such as Phase III trials. The requirement codifies the U.S. Food and Drug Administration’s ongoing effort to encourage clinical trial recruitment strategies that improve participation from communities of color and other underrepresented populations.
The FDA released a guidance document for trial sponsors in April 2022 that emphasized improving enrollment of participants from underrepresented racial and ethnic populations in clinical trials. While that’s an important step in recruitment, it can’t happen unless trial sponsors have built trusting relationships with the communities they hope to enroll. That takes time – and it’s more about boots on the ground than plans in a binder.
Joanice Thompson is Acclinate’s Adviser for Community Engagement and Partnership Building. In this post, she reflects on the most common barriers to achieving diversity in recruitment, what it takes to enhance clinical trial diversity, and how trial sponsors should build and maintain community partnerships.
Thompson spent 35 years at the University of Alabama at Birmingham (UAB). She started in a research interviewer role and retired as the Director of Community Engagement for the UAB Division of Preventive Medicine. After retirement, she continued her work as a consultant for UAB’s Minority Health & Health Disparities Research Center.
Thompson names two important barriers to clinical trial participation in communities of color: trust and education.
The Birmingham area, with a nearly 70% Black population, is roughly a two hour’s drive from Tuskegee. Half a century later, the memory of the Tuskegee study still sits with the community. Use the word “research,” Thompson said, and people get defensive. Instead of avoiding the subject, though, it’s important to talk about what made it so bad and why today’s clinical trials are different.
That points to the value of education in combatting the consequence of a lack of diversity in clinical trials. Before jumping into recruitment, trial sponsors need to address basic health and the role of tested, approved therapies in improving health. Again, it helps if this conversation is honest. Does someone know someone who “met an untimely death” – or was it a lack of access to medical care or medication that could have prolonged their life?
Talking about the clinical trial comes next. However, the focus should be on what a trial does and why it’s important to test medications so that they achieve desired outcomes for everyone. This step is critical in communities of color: A 2023 EY survey found roughly 30% of Black and Hispanic individuals were unaware of clinical trial opportunities, compared to 14% among White individuals.
Only after building trust and providing education, Thompson said, can a sponsor effectively start to ask if individuals want to enroll in a trial.
In a 2021 report, Deloitte and PhRMA highlighted the growing role of community relationships in health equity initiatives. Thompson referred to this as “boots on the ground.”
Thompson has seen how effective this approach is firsthand. She says that trial sponsors need to be prepared to go anywhere in the community where people gather. That could be the church, the school, the choir, the senior center, the VFW, and so on. Beyond speaking to members of community groups, sponsors need to build rapport with community leaders – and, if necessary, obtain signed letters of support from them, Thompson explains.
Once trial sponsors build rapport and establish relationships, Thompson said, they have “anchor organizations” who endorse their work. If the sponsor knows an organization is hosting a community event, for example, they can plan to be present and provide educational resources suitable for the population that will be attending.
Anchor organizations may prove valuable in additional ways. One is helping trial sponsors identify potential barriers to clinical trial participation in the community. Will waiting rooms need extra accommodation for family members? Is a potential site served by mass transit? Can a site schedule visits at convenient times for patients such as shift workers or stay-at-home parents? Answering these questions is key to successful health equity initiatives, as it removes obstacles that may turn away members of the community otherwise interested in participating in a trial.
Trial sponsors can further engage with anchor organizations to connect them to influential members of the community with a knack for communicating and building an audience both in person and online. This is especially valuable for trials leveraging access to communities of color through platforms such as NOWINCLUDED, the community engagement arm of Acclinate. Through NOWINCLUDED, people of color interact and build relationships with supportive communities while also learning about the clinical trials and health resources available to them through both in-person events and digital avenues.
As communities of color are historically underrepresented in clinical trials, the clear short-term goal for a sponsor’s clinical trial recruitment strategies is participation more in line with the general population. (The United States population as a whole is 19% Hispanic and 14% Black.)
The more important goal, according to Thompson, is establishing a presence in the community. The effort that goes into breaking barriers, building trust, and educating individuals has a long-term payoff of helping people see the value of clinical trial participation for themselves and their community. Over time, that effort makes it easier to recruit – and to demonstrate that trials are making a difference.
Boost inclusivity in trials faster and for the long term by zeroing in on the populations you lack. Acclinate gives you access to communities of color, facilitates engagement around your trials, then analyzes the data generated to predict and plan where and when your next effort should happen to create the ongoing representation you need. To learn more, schedule a 1:1 Meeting.