What is the best way to recruit participants to join a clinical studies registry, and can such registries help better diversify clinical research samples? These are two critical questions that UCI researchers are tackling with a new National Institutes of Health (NIH) grant, “Recruiting and Retaining Participants from Disadvantaged Neighborhoods in Registries.” The work will be led by Joshua Grill, professor of psychiatry and human behavior in UCI’s School of Medicine (SOM) and of neurobiology and behavior in UCI’s School of Biological Sciences (Bio Sci), and by Daniel Gillen, Chancellor’s Professor and chair of the Statistics Department in the Donald Bren School of Information and Computer Sciences (ICS).
The multidisciplinary team will focus in particular on participant recruitment and retainment for Alzheimer’s disease and related disorders (ADRD) research. More than 6 million Americans are living with Alzheimer’s, and one in three seniors dies with Alzheimer’s or another dementia. Yet ADRD clinical research faces delays and risks to validity when populations at increased risk for disease are excluded from studies. Grill and Gillen will examine what role recruitment registries for ADRD research can play in overcoming exclusions to improve research outcomes.
As noted in the grant abstract, recruitment registries can help accelerate participant accrual in ADRD research. These repositories store the names of potentially eligible individuals who have already consented to being contacted about studies, but little research has been done surrounding registry design, conduct and effectiveness in aiding ADRD research recruitment.
“We’re particularly excited about the team science approach in this grant, which includes experts in statistical methods, Alzheimer’s disease and related dementias, and social determinants of health and health disparities,” says Grill, who serves as director of UCI’s Institute for Memory Impairments and Neurological Disorders (UCI MIND). Grill established the UCI Consent-to-Contact (C2C) registry, which matches adults in Orange County with clinical research studies at UCI.
“There is increased recognition of the need for a ‘science of recruitment and retention,’” says Grill. “This new award from the NIH National Institute on Aging will allow us to accelerate this science through innovative but rigorous studies of means to get people from diverse neighborhoods into our local C2C registry and keep them in it until they can be enrolled in a study.”
Novel Statistical Methods
Part of this effort to increase diversity in clinical ADRD trial participation will be the development of novel statistical methods to implement and estimate the effects of new targeted recruitment strategies. This is where Gillen and his Ph.D. students in ICS come into play.
“We have the opportunity to identify novel strategies for increasing diversity in research participation while developing state-of-the-art statistical methods that are necessary to validly assess our approaches,” explains Gillen, who directs the Data Management and Statistics Core at the UCI Alzheimer’s Research Disease Center (ADRC). “Successful achievement of our study goals requires the development of novel statistical methodology that builds on our group’s past accomplishments in interrupted time series models and corrections for non-random sampling designs.”
With $3.7 million in funding over the next five years, this research aims to quantify the bias associated with these recruitment tools and develop methodology for addressing such bias. “This work represents the best of collaborative research for me,” says Gillen. “Motivated by important research questions in recruitment science, we will be able to extrapolate the results from our local C2C registry to the broader U.S. population.”
— Shani Murray