Eli Lilly recruits black patients for Alzheimer’s trial as drugmaker seeks diversity in clinical studies

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Sharon Kimbrough went to the Black Women’s Expo in Atlanta to sell her memoir. Getting tested for Alzheimer’s was the furthest thing from her mind, but when the nurses Eli Lilly company contacted them about the new test, they decided to let them draw their blood.

“I had two family members who had Alzheimer’s,” said Kimbrough, a retired advertising executive. “Sometimes I have memory problems and some of it is old age. But it could be something else.”

Eli Lilly The House of Black Women ran two mobile labs to recruit older Black women for the new test. The drugmaker developed Labs on Wheels in 2020 to continue with its clinical trials in the first year of the COVID pandemic.

“We had to get really creative about how we were able to reach out to the community,” explained Lashan Neville, Eli Lilly’s senior director for central clinical services.

What started out of necessity has now become a vehicle for diversifying the drugmaker’s trials and building trust in communities of color, which have traditionally been underrepresented in clinical research.

Tuskegee Heritage

Black patients have generally shown greater reluctance to participate in clinical trials than whites. A study by the Alzheimer’s Association found that 62% of African Americans think clinical research is biased against people of color.

Part of the mistrust may stem from the legacy of the 20th-century Tuskegee syphilis experiment, in which government researchers withheld treatment from black participants to study disease progression, but not from their white counterparts.

Eli Lilly researchers say that leveraging mobile research units to meet patients at community events has helped recruit more diverse trial participants, especially those in the black community.

“We’re educating people about clinical research … how to be a part of it, how they can use the research, in a way, a different way for them to access health care,” Neville said. “

decentralized testing

Finding and enrolling patients can be the most expensive and time-consuming part of clinical trials. The National Bureau of Economic Research estimates the average value at $19 million. Traditionally, clinical trials have been centered around academic medical centers, but facilities are often too far to travel for patients who do not live in large metropolitan areas.

Retailers cvs health, Walgreens And Kroger announced new initiatives to provide clinical trial enrollment and follow-up services in their pharmacy clinics, which could help researchers reach patients closer to home in their communities.

Increasingly, drug manufacturers are taking a more direct route to patient access through social media to speed up the enrollment process.

Amyloid plaques accumulate on the outside of neurons. Amyloid plaques are characteristic of Alzheimer’s disease. They lead to degeneration of the affected neurons.

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According to a survey by the Center for Information and Study on Clinical Research, before the pandemic, the top three ways most patients learned about the test were through traditional advertising, their doctors and research centers. Social media did not even find a place in the top ten. By 2021, while advertising remained the top source, social media replaced doctors as the second most likely way trial participants learned about clinical studies.

pfizer CEO Albert Bourla says that social media has become a useful way to recruit participants.

“We go with social media, in addition to all the measures that we take, to target populations … that are underrepresented in clinical trials,” Bourla told CNBC. “We do this because not only will their representation be increased but we are also in general increasing the speed with which we can enroll patients into the study.”

FDA pushes for diversity

The Food and Drug Administration has encouraged drug manufacturers to broaden the criteria for enrolling trial participants to include racial, geographic and age differences in order to increase diversity in general. Blacks are 1.5 to 2 times more likely to develop Alzheimer’s disease than whites. Yet, an academic review of pre-pandemic dementia research found only 4% of participants in trials who reported race and ethnicity were black or Hispanic.

FDA Commissioner Dr. Robert Calif applauds efforts to decentralize testing sites, using technology and mobile labs to make tests more accessible to a more diverse range of Americans. However, he says, there are limits.

“In some cases, it’s not the right thing to do. For example, if you’re studying, a new drug that hasn’t been tested in many people, you need to be in a very intense environment and an academic medical center.” Could be.” Dr. Calif told CNBC. “For other types of tests, it does the job perfectly.”

Sharon Kimbrough is willing to do her part to help promote representation, but she hopes that Lily will not qualify for the trial. The blood sample she gave at the mobile lab is being analyzed for high tau protein levels, which is associated with Alzheimer’s disease.

“I hope I find out that I don’t have a protein that means I have Alzheimer’s,” she said. “It will be everyone’s joy.”

She’s still waiting for blood test results, but in her memoir, Kimbrough writes about finding faith in overcoming life’s personal struggles. A positive result will open a new chapter.

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