Furthering work started last year, Daniel L. Gillen, professor and chair of the Department of Statistics, is continuing to collaborate on Alzheimer’s disease (AD) research with Joshua D. Grill, associate professor of psychiatry and human behavior in the UCI School of Medicine and director of the UCI Institute for Memory Impairments and Neurological Disorders (MIND). With their new four-year $1.2 million National Institutes of Health (NIH) grant, “Effects of Alzheimer’s Disease Clinical Trial Study Partners,” Gillen and Grill aim to help researchers better understand how study partners for AD patients affect clinical trial data. This builds on earlier work by Gillen and Grill related to the study partner requirement for AD patients.
Clinical trials are essential to finding new therapies for AD patients, but the cognitive status of such patients requires them to enroll with a study partner. As Gillen and Grill note in their grant proposal, “the quality of AD trial data is inherently tied to the study partner’s ability to provide complete, accurate and consistent assessments of patient outcomes.” To test their hypothesis that study partner characteristics are associated with variance and bias in trials, they are examining data from AD and mild cognitive impairment (MCI) trials. “Specifically, we will examine whether study partner characteristics are associated with trial recruitment, retention and data integrity outcomes.”
Performing modeling experiments, they will investigate how altering trial enrollment patterns and protocol decisions affect trial data precision and accuracy. Then, they will develop software that incorporates their results to help trialists better plan their studies. The newly generated software will be incorporated into Gillen’s existing R software package, RCTdesign, a comprehensive package for designing, monitoring and analyzing group sequential and adaptive clinical trials. As explained in the proposal, “this project will yield a greater understanding of study partner impact on trial data integrity and will enable improved design and conduct to reduce missing data and increase statistical power and data validity.”
— Shani Murray