Ensuring diversity in clinical trials is a growing concern in the life sciences space. According to the FDA’s Drug Trials Snapshot, about 75% of participants in studies for new molecular entities and therapeutic biologics approved in 2020 were white.
Meanwhile a study published early last year in JAMA Network Open found 58% of U.S.-based vaccine trials reported race, and only 34% recorded ethnicity information.
Jennifer Jones-McMeans, divisional vice president of global clinical affairs for Abbott’s vascular business, told MobiHealthNews it’s important for doctors to be able to tell their patients that therapies have been tested on them and their population.
“If you consider the diversity of people – not only in the United States but globally – we should be striving that they are represented in the trials that are conducted to provide a sense of assurance that they were considered, that their cultural and gender background was considered, when a therapy was being evaluated,” she said.
Some groups are also more likely to be affected by certain conditions and diseases. Jones-McMeans is leading the LIFE-BTK study, which is evaluating a treatment for critical limb ischemia in people with advanced peripheral artery disease. Black Americans are more likely to be affected by PAD, and they suffer worse outcomes, like amputation.
“I think we have to look at health equity in totality. When you think about disease, and chronic disease specifically, there are populations that are far more burdened than others. And so we have to pay attention to that,” Jones-McMeans said.
But there are barriers to enrolling patients from underrepresented communities in clinical trials. A long history of racism in medicine contributes to a lack of trust in clinical research for some communities. Plus, it can be difficult for some people to commit to the follow-up care needed to participate in a trial.
Jones-McMeans said bringing in physicians who are part of and work with disadvantaged communities can help with trust. It’s also useful to provide support services for trial participants, like reimbursing for food and travel, considering home visits and budgeting for translators so patients who don’t speak English fluently can be included.
Understanding what a clinical trial is, how it works and how you can participate isn’t necessarily mainstream knowledge.
“Education is key, because one thing that all health institutions and companies are fighting against is misinformation. We need to make sure we clear that up, make sure that somewhere there’s a single source where patients can get reliable information,” Jones-McMeans said.
Though these changes can help, the entire healthcare system will need to contribute to push for increased diversity in clinical trials.
“[We] actually need to invest in a system that will support diversity from a grassroots effort of educating young physicians, and researchers, and healthcare providers that can be trained to provide the support to patients that’s needed,” she said. “So this is a long game, and it’s a marathon that we’re going to have to continue to invest in and work on to impart change.”
The HIMSS22 session “Diversity & Inclusion in Clinical Trials” will take place on Wednesday, March 16, from 1:00 p.m. to 2:00 p.m. in Orange County Convention Center W303A.