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 nurses from Eli Lilly approached her in regards to the company’s recent trial, she decided to allow them to draw her blood.
“I had two relations that had Alzheimer’s,” said Kimbrough, a retired promoting executive. “Sometimes I even have memory issues and a few of it in older age happens. But it surely may very well be something else.”
Eli Lilly drove two mobile labs to the Black women’s gathering, to recruit older Black women for a recent trial. The drugmaker developed the labs on wheels in 2020, to maintain its clinical trials moving into the primary yr of the Covid pandemic.
“We needed to get really creative about how we were in a position to have outreach locally,” said Lashan Neville, Eli Lilly’s senior director for central clinical services.
What began out of necessity has now turn out to be a vehicle for driving diversity within the drugmaker’s trials and constructing trust in communities of color, which have traditionally been underrepresented in clinical research.
Tuskegee legacy
Black patients have generally shown more hesitancy to take part in clinical trials than white patients. A study by the Alzheimer’s Association found that 62% of African Americans think clinical research is biased against people of color.
A part of the mistrust may stem from the legacy of the twentieth century Tuskegee syphilis experiment, through which government researchers withheld treatment from Black participants, but not their white counterparts, as a way to study the progression of the disease.
Eli Lilly researchers say leveraging the mobile research units to fulfill patients at community events has helped recruit more diverse trial participants, especially within the Black community.
“We’re educating people about clinical research … be a component of it, how they’ll use research, as a way, a special way for them to get access to health care,” Neville said.
Decentralized trials
Finding and enrolling patients could be amongst the costliest and time-consuming a part of clinical trials. The National Bureau of Economic Research estimates the median price at $19 million. Traditionally, clinical trials have centered around academic medical centers, however the facilities are sometimes too far to travel for patients not living in large metropolitan areas.
Retailers CVS Health, Walgreens and Kroger have announced initiatives to supply clinical trial enrollment and follow-up services of their pharmacy clinics, which could help researchers reach patients of their communities, closer to home.
Increasingly, drugmakers are taking a more direct path to patient outreach to hurry up the enrollment process, through social media.
Amyloid plaques accumulate outside neurons. Amyloid plaques are characteristic features of Alzheimer’s disease. They result in a degeneration of the affected neurons.
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Before the pandemic, the highest 3 ways most patients learned about trials were through traditional promoting, their doctors and research centers, in keeping with a survey by the Center for Information and Study on Clinical Research Participation. Social media didn’t even rank in the highest 10. By 2021, while promoting remained the highest source, social media replaced doctors because the second-most likely way trial participants learned about clinical studies.
Pfizer CEO Albert Bourla says social media has turn out to be a useful strategy to recruit participants.
“We go together with social media along with all the opposite measures that we take to targeting populations that … are underrepresented in clinical trials,” Bourla told CNBC. “We do this because not only will that increase the representation of them but additionally we’re increasing, on the whole, the speed with which we are able to recruit patients within the study.”
FDA push for diversity
The Food and Drug Administration has encouraged drugmakers to broaden criteria for enrolling trial participants to extend diversity on the whole, to encompass racial, geographic and age differences. Black individuals are 1.5 to 2 times as likely as white people to develop Alzheimer’s disease. Yet, one academic review of pre-pandemic dementia research found just 4% of participants in trials that reported race and ethnicity were Black or Hispanic.
FDA Commissioner Dr. Robert Califf applauds efforts to decentralize trial sites and using technology and mobile labs to make trials more accessible to a more diverse swath of Americans. There are limits, though, he said.
“In some cases, it isn’t the suitable thing to do. For those who’re studying, for instance, a recent drug that hasn’t been tested in many individuals, it’s possible you’ll have to be in a really intense environment and a tutorial medical center,” Califf told CNBC. “For other forms of trials, it’s absolutely the suitable thing to do.”
Kimbrough, on the Black Women’s Expo, is willing to do her part to assist boost representation, but she’s hoping she won’t qualify for the Lilly trial. The blood sample she gave within the mobile lab is being analyzed for elevated Tau protein levels, which has been related to Alzheimer’s disease.
“I hope I discover I do not have the protein which means I likely have Alzheimer’s,” she said, adding “that may be the enjoyment of all of it.”
She’s still awaiting the blood test consequence, but in her memoir Kimbrough writes about faith helping her overcome life’s personal struggles. A positive result would usher in a complete recent chapter.
Correction: This text has been revised to reflect the right name of the Center for Information and Study on Clinical Research Participation.