Eli Lilly is recruiting black sufferers for Alzheimer’s trials as drugmakers search range in medical trials

Sharon Kimbrough went to Atlanta’s Black Women’s Expo to sell her memoir. Getting tested for Alzheimer’s was the furthest thing on her mind, but off as nurses Eli Lilli When she approached her about the company’s new process, she decided to have blood drawn.

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

Eli Lilli drove two mobile labs to the black women’s meeting to recruit older black women for a new trial. The drugmaker developed the labs on wheels in 2020 to keep its clinical trials going during the first year of the Covid pandemic.

“We had to get really creative with how we could reach the community,” said Lashan Neville, Eli Lilly senior director of core clinical services.

What started out of necessity has now become a means to drive diversity in the drugmaker’s trials and build trust in communities of color that have traditionally been underrepresented in clinical research.

Tuskegee heritage

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

Some of the distrust may stem from the legacy of the 20th-century Tuskegee Syphilis Experiment, in which government researchers withheld treatment from black participants, but not from their white counterparts, to study the progression of the disease.

Eli Lilly researchers say using the mobile research units to meet patients at community events helped recruit more diverse study participants, particularly in the black community.

“We’re educating people about clinical research … how to participate, how to use the research as a way, a different way, to access healthcare,” Neville said.

Decentralized Studies

Finding and enrolling patients can be one of the most costly and time-consuming parts of clinical trials. The National Bureau of Economic Research estimates the median price at $19 million. Traditionally, clinical trials have been centered in academic medical centers, but facilities are often too remote for patients who do not live in large metropolitan areas.

retailers CVS Health, Walgreens And Hook have announced new initiatives to provide registration for clinical trials and follow-up services at their pharmacies, which could help researchers reach patients in their communities closer to where they live.

Drug manufacturers are increasingly adopting a more direct approach to patient engagement to speed up the enrollment process through social media.

Amyloid plaques accumulate outside of neurons. Amyloid plaques are hallmarks of Alzheimer’s disease. They lead to degeneration of the affected nerve cells.

Getty Images

According to a survey by the Center for Information & Study on Clinical Research, the top three ways most patients found out about trials before the pandemic were through traditional advertising, their doctors, and research centers. Social media didn’t even make the top ten. By 2021, while advertising remained the primary source, social media replaced physicians as the second most likely way study participants learned about clinical trials.

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

“We’re going with social media in addition to all the other actions we’re taking to target audiences that are … underrepresented in clinical trials,” Bourla told CNBC. “We’re doing this because not only does it increase their representation, but we generally increase the speed at which we can recruit patients into the study.”

FDA pushes for diversity

The Food and Drug Administration has encouraged drug manufacturers to broaden the criteria for enrolling study participants to generally increase diversity and include racial, geographic, and age differences. Blacks are 1.5 to 2 times more likely to get Alzheimer’s than whites. However, a scientific review of dementia research prior to the pandemic found that only 4% of participants in studies that reported race and ethnicity were black or Hispanic.

FDA representative Dr. Robert Califf applauds efforts to decentralize testing sites and the use of technology and mobile labs to make testing more accessible to more Americans. However, he says there are limits.

“In some cases it’s not the right thing to do. For example, if you’re investigating a new drug that hasn’t been tested on many people, you may need to be in a very intensive environment and academic medical center,” said Dr. Califf to CNBC. “It’s absolutely right for other types of studies.”

Sharon Kimbrough is willing to do her part to strengthen representation but is hoping she doesn’t qualify for the Lilly process. The blood sample she gave to the mobile lab is analyzed for elevated levels of the protein tau, which has been linked to Alzheimer’s disease.

“I hope I find out that I don’t have the protein, which means I probably have Alzheimer’s,” she said, adding, “That would be the joy of the whole thing.”

She is still awaiting the result of the blood test, but in her memoir Kimbrough writes about the faith that helps her overcome life’s personal struggles. A positive result would open a whole new chapter.