Abbott will spearhead an initiative to help increase diversity in clinical trials through boosting access, funding scholarships and uniting leaders on an advisory board, the company announced today.
When Abbott kicked off its current LIFE-BTK study, which is examining a therapy to treat peripheral artery disease (PAD), it became clear that the company would need to do more to invest in trial diversity. Not only are certain communities of color, particularly Black people, disproportionately affected by PAD, but they often do not receive the same quality treatment as their white counterparts.
Boosting access to the LIFE-BTK trial among Black people, then, was seen as an essential step toward bridging that disparity, according to Jennifer Jones McMeans, divisional VP of global clinical affairs for Abbott’s vascular business.
“We knew that in our development of this therapy, it was important that we were as inclusive as possible to make sure those burdened by the disease would be part of the evaluation of it,” McMeans said. “Abbott decided to say, ‘This is an evolving point for us – that across our portfolio of clinical trials, we can create an environment of inclusivity and increase the number of women and people of color in all of our clinical trials.’”
Even though people of color make up about a quarter of the U.S. population, a significantly smaller percentage participate in clinical trial research. A 2018 study out of the Johns Hopkins Bloomberg School of Public Health, for instance, found that fewer than 5% of breast cancer studies were stratified by race and socioeconomic factors. Not surprisingly, lack of trust and access have been cited among the barriers to participation in research.
Abbott plans to invest in four main areas. It will provide funding and scholarships for future trial leaders, with $5 million earmarked for nearly 300 scholarships across the next five years. Those funds will be concentrated at HBCU (historically Black colleges and university) medical schools, such as the Howard University College of Medicine, Meharry Medical College and the Morehouse School of Medicine.
Abbott will also create a diversity and research medical advisory board consisting of doctors, trial organizers and health advocates. It is designed to counsel the company on eliminating barriers to clinical trial access among underrepresented populations.
Internal funding will go toward training diverse investigators, providing new sources of accessibility for patients who want to participate in clinical trials (such as transportation or home visits) and language and translation services for non-English speaking communities.
Finally, Abbott hopes to “convene the industry for change,” as McMeans put it, by working with patient advocates, industry experts and physician leaders to publish an open-source perspective on boosting clinical trial diversity.
McMeans said Abbott hopes to address the lack of trust that contributes to low research participation by people of color. To do so, the company plans to train physicians who work in underrepresented communities and advocate for them to run clinical trial sites.
“We’re trying to bring in new physicians who may not necessarily have had a background in clinical trial work, but who serve the community that looks like them,” McMeans explained.
Abbott is already up and running in San Antonio. Dr. Lyssa Ochoa, a vascular surgeon based in the city, established the SAVE clinic for vascular and endovascular care in zip codes where people of color – specifically the Latino population – are medically underserved. The company has partnered with Ochoa to run a LIFE-BTK clinical trial site.
“Here you have a physician who’s dedicated to treating that community of patients who are diabetic and with severe forms of PAD, and she’s now able to provide an option for these patients to potentially receive a new therapy that’s under investigation in concert with the FDA,” McMeans said.
McMeans believes the Abbott initiative will help chip away at some of these health disparities by providing underserved populations with more access to potentially life-saving treatments. Removing the stigma that clinical trials are “experiments” is a huge part of that effort.
“It’s very important that companies like Abbott and other sponsors do the work to make sure evaluations of these therapeutics include patients who are very much in need of new treatments,” McMeans said. “What helps is when a physician can say, ‘This therapy I’m treating you with has been evaluated in populations such as yours – women, Black, Latino, Native Americans.’ When patients can say, ‘I was included in the evaluation of this product,’ that gives them a different level of trust of whether or not they should be treated with it.”