Print      
Researchers seek clinical trial diversity
By Max Blau
STAT

ATLANTA — Faced with an urgent need to recruit more patients of color into clinical trials, researchers are trying a flurry of new ideas — including training black pastors in Chicago to serve as recruiters and sending a bus outfitted with exam rooms throughout rural Georgia.

The outreach comes from medical schools, pharma companies, tech entrepreneurs, and even the federal government, which aims to recruit a million volunteers willing to share their genetic and health data with the Precision Medicine Initiative.

Members of minority populations have long been underrepresented in clinical trials. Hispanics make up one-sixth of the US population but only 1 percent of clinical trial participants, according to the Food and Drug Administration. African-Americans, meanwhile, accounted for 7 percent of trial participants even though they make up 13 percent of the US population.

Now a small army of drug makers, health care researchers, and community organizers nationwide are working to rebuild trust that was broken in past medical scandals. Those leading the charge believe doing so benefits communities and companies alike in a country that is on track to become majority-minority by 2060. They also hope it can save billions of dollars lost each year to health disparities.

“[Minorities] have not yet quite figured out how, or when, they should trust that their health info will be protected, or that their information won’t later be used against them,’’ said Dr. Elizabeth Ofili, a cardiologist and director of Morehouse School of Medicine’s Clinical Research Center.

This gap — which has led to costly delays of drug trials — has prompted some pharmaceutical giants to embark on major diversity initiatives. Lilly, for example, has boosted minority patient populations to over 25 percent at more than 400 clinical trial sites.

Among the new tools: reaching out to patients through firms like ePatientFinder. CEO Tom Dorsett’s company works with doctors to analyze electronic health records and connect patients with researchers. In some cases, ePatientFinder has hired bilingual patient coordinators to connect Spanish-speaking patients to researchers behind drug trials.

“There’s some promise with online portals,’’ said Thomas Concannon, associate professor at Tufts University School of Medicine and senior policy researcher at the RAND Corp. “When [patients are] done with a doctor, [they] can go to patient portal, and in that process, there are some experiments happening where patients are introduced to clinical trial information.’’

Obstacles, though, still remain, even when those connections happen. Fred Rachman, CEO of the community health collaborative AllianceChicago, said that “smart, well-intentioned researchers’’ often present fleshed-out ideas that “reinforce in the minds of the disenfranchised that someone is doing something to them.’’ Instead, he said, researchers hoping to conduct clinical trials need to involve communities in the entire research process.

Morehouse has worked to include minority residents by creating a community advisory board, offering drug trial times outside traditional work hours, and driving its mobile clinical research unit throughout the state of Georgia. They have also hired a patient research advocate whose job is to ensure study participants are aware of information about trials, from data protection to the final findings.

“They trust us — but trust isn’t unlimited,’’ Ofili said. “When we work with them, we follow up with them and tell them what we found, and make sure they get access to the drug.’’

In places lacking a trusted institution like Morehouse, a historically black college based in Atlanta, grass-roots organizers have stepped up to bridge the gap. Regina Greer-Smith, a former hospital administrator, has recently trained African-American pastors on Chicago’s South Side to get churchgoers “research-ready’’ — demonstrating how proper clinical trials work and explaining the benefits of participation.

“Until we learn how to engage and build trust, we can’t even talk about enrollment in trials,’’ Greer-Smith said.

Down the road, Greer-Smith said that training could connect drug companies with a pipeline of clinical trial participants — provided that disenfranchised communities see the benefit, too.

Those benefits can include discoveries that can save lives. Research uncovered, for example, the fatal side effect of an antiseizure drug for people of Asian descent. At Morehouse, researchers found that tPA, a popular stroke treatment, benefited white patients more than black patients. “And if you’re an African-American woman,’’ said Dr. Roger Simon, a neurology professor who was part of the research team, “you might not see any effect — and it’s worse than that because there are side effects like deep, big brain hemorrhages.’’

Such examples show the value — for pharma companies, researchers, and patients alike — of confronting diversity gaps in clinical trials.

“We’re all in the same boat,’’ Greer-Smith said. “We all want the same things.’’

Max Blau can be reached at max.blau@statnews.com. Follow Max on Twitter @maxblau.