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Abbott's takeaways on boosting clinical trial diversity

ORLANDO, Fla. – While technology continues to propel clinical trials, research in the U.S. still lacks accurate representation of the country. 

“What we know is that race and ethnicity are social constructs and are not dependent on our genes,” Jennifer Jones-McMeans, divisional vice president of global clinical affairs for Abbott’s vascular business, said during a HIMSS22 session. “When we look at diseases and specific conditions in cardiovascular health … what we do know is that these diseases’ prevalence [is] much higher in people of color. So, if it’s not biological, then what is it? We can look at social determinants of health.”

Jones explained that income, education, access to food, a person’s community and social context, and access to healthcare can also make up a person’s social determinants of health. 

Currently, people of color are under-represented in clinical trials. Harvard Business Review reports that people of color make up about 2%-16% of patients in clinical trials but 39% of the U.S. population. Race and ethnicity data are also often missing from study data. According to a JAMA study published in 2021, only about half of studies reported race data. 

Working with clinicians that are representative of the community you are looking to serve is key, she noted. Jones gave the example of a recent Abbott study called LIFE-BTK, which is focused on treating critical limb ischemia in people with advanced peripheral artery disease. In this study, Abbott teamed up with community partners and helped train new clinicians on conducting clinical trials. 

“We’ve been trying to get a strategy of making sure our trial messengers are more representative of what these patients look like,” she said. 

To help expand this physician group, Jones-McMeans said that Abbott is investing in historically Black colleges and universities’ medical schools, as well as investing in training more physicians to conduct clinical trials. 

To help break down barriers to participation, the study also provided reimbursement for transportation, as well as food and housing to patients who had to travel from long distances. The study also provided home visits for participants. 

Researchers got feedback from the clinical staff that patients need a single source of information about their disease and clinical trials. 

“We were seeing patients going in [to the doctors, and] let’s say that the physician would sit down with them for consent. Patient might say, ‘Ok. I’m going to take it back [to my family].’ Then, the family says, ‘You’re not going to be in an experiment,'” Jones-McMeans said. “So that killed it right then.”

To remedy this, Abbott created a patient-facing platform, where participants and their families could access additional information about the clinical trial and their condition. 

“We couldn’t make it a website of jargon; [it] had to be patient-facing and friendly,” Jones-McMeans said. “One of our videos is a patient video that is planted on the webpage that walks them through what a clinical trial is. Some of the first language is about their disease. We want them to understand their disease as a patient, and then let me explain to you why we are doing this clinical trial.”

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