CHICAGO—Slow recruitment in Alzheimer's disease (AD) trials and a lack of diversity in cohorts prompted officials with the National Institute on Aging (NIA) to discuss a multipronged attack to boost recruitment in studies and the quality of data collected here at the Alzheimer's Association International Conference.
The efforts, outlined in a special session on trial recruitment, include new National Institutes of Health inclusion criteria that is scheduled to go into effect in January 2019, a review of the makeup of cohorts in AD trials historically, identification of hurdles that seem to be impeding recruitment, and an ongoing funding opportunity for research into the science of recruitment itself.
The need for improved recruitment and data collection has never been more urgent, because of the number of trials in the accelerated push for new therapeutics, said Marie Bernard, MD, deputy director of NIA, who helped lead a session here at the Alzheimer's Association International Conference.
"We need to get these things moving," she said. "We need to have data that is representative of a broad variety of individuals so that we can make sure that whatever treatments are put forward are generalizable."
The new NIH inclusion criteria will require anonymized, individual-level data on age, sex/gender, and race/ethnicity.
Researchers with the NIA reviewed data for the 165 trials on AD and AD-related dementias that were listed on the Clinicaltrials.gov. They found that about 68 percent of the participants in the trials were non-Hispanic white, 18 percent African American, and about 8 percent Hispanic, Dr. Bernard said.
"There are opportunities for enhancing the improvement of groups beyond non-Hispanic whites," she said. Researchers also found that more of the subjects were male than female, even though, "that's not the way — in the real world — it works."
"Women live longer and tend to have more problems with Alzheimer's disease," she said.
Trial data also revealed 18 broad exclusion categories, often necessary, including concomitant medications, cardiovascular issues, and renal dysfunction.
Dr. Bernard said the array of exclusion factors are helping to slow recruitment. Recruitment is also hampered by other factors, such as the need for an unimpaired partner, and a lack of awareness of Alzheimer's trials among practitioners and the general public, she said.
The NIA is also working on a national recruitment strategy, which will recommend specific tools researchers and research centers can use to improve "messaging, partnering, building study site capacity and other opportunities."
The agency also emphasized at the AAIC its ongoing funding for researchers working on "innovative participant recruitment and retention methods." Because of recent boosts to the budget, Dr. Bernard said, the NIA is planning to "fully fund all of the projects that we find to be highly meritorious based upon peer review."
She emphasized the need for research centers to think locally in terms of recruitment — what works in one region may not work in another, so local hurdles need to be identified and overcome. For instance, Dr. Bernard recalled her days working in academic research in Oklahoma, where researchers drew subjects from Native American tribes, who had specific viewpoints on what is done with brains and genetic information.
"The way that you might approach people in tribal communities who are involved in an Alzheimer's-type study might be very different from the way that you approach a college professor in Boston," she said.
Jim Hendrix, PhD, director of the global science initiatives at the Alzheimer's Association, said these are important steps.
"We know that, after funding, the biggest challenge for Alzheimer's research is getting people enrolled in clinical trials," he said. "Another big challenge is simply that in Alzheimer's, as in many other diseases, our clinical trial subjects, our clinical trial population, is not as diverse as the American population is: They tend to be overwhelmingly white, middle-class or upper-middle-class, they tend to be more well-educated than the average American. And if we really want to develop new drugs and learn about Alzheimer's disease specifically, we need to have trials that reflect the actual population of the country."
Dr. Hendrix added he hopes that new clinical practice guidelines unveiled at the AAIC, on diagnosis and referral for primary care physicians, will have an effect on trial awareness and enrollment.
"We don't diagnose with specialists, usually," Dr. Hendrix said. "It's usually through a primary care physician, and the primary care physicians are not necessarily tapped in to our clinical trials."
The study was funded by the National Institutes of Health. The sources interviewed reported no disclosures.
LINK UP FOR RELATED INFORMATION:
AAIC Abstract 23461: Bernard MA, et al. New NIH policies on inclusion — Implications for Alzheimer's clinic study recruitment and tools to help.