The Advanced Analytics Research Core of the UR-Udall Center will unite deep biostatistical expertise and PD research experience at the University of Rochester with leading computational science talent from the University of Rochester, Johns Hopkins, Aston University, Sage Bionetworks, and MIT to support the UR-Udall Center’s research projects and to conduct novel cross-project analyses. These projects will rely on large data sets, including the largest repository of PD clinical trial data (Project 1) and enormous data streams from smartphones (Project 3) and novel principally passive sensors (Project 4). The Advanced Analytics Research Core will rely on the talents of the Core’s investigators, the resources of the individual institutions, and the data management expertise of the Center for Health + Technology to conduct its work.
To enable cross-project analyses, we will enroll a group of “Super Users” (50 with PD and 20 without) that will undergo a standardized battery of in-clinic assessments over two yearsin addition to evaluation by at least three of the four sensors that are part of Research Projects 3 and 4, specifically smartphone, wearable sensor, video-based sensor, and radio wave-based sensor. This group will be one of the first to pair traditional clinical PD assessments with evaluations by multiple novel sensors in clinical and real-world settings. This highly characterized group will enable evaluation of the sensors’ relative ability to differentiate those with PD from those without, to detect disease progression, to assess response to current medications, and to produce novel insights into PD that cannot be ascertained currently from in-clinic measurements. Beyond the work of the UR-Udall Center, the Advanced Analytics Research Core will be a resource for the Udall Center network and will also attract, develop, and mentor biostatistical and computational science talent for the greater PD community.
The UR-Udall Center’s Clinical Core has the capability to conduct remote assessments nationally and in person assessmentslocally. For a decade, the Core’s investigators have pioneered the use of video visits to conduct phenotypic assessments of individuals with PD and other neurodegenerative conditions. These efforts have involved novel partners, including 23andMe, pharmaceutical companies, and the Michael J. Fox Foundation. The largest effort connected 166 participants with PD in 39 states all to a single research “site.” The Core will use simple, secure video conference software and inexpensive web cameras to support Project 2 and enable the first virtual, national longitudinal study of LRRK2 carriers with and without PD.
The Clinical Core also has extensive experience conducting in-person assessments to evaluate the relationship between traditional measures and those conducted with novel sensors, including smartphones and wearable sensors that are part of Projects 3 and 4. In addition, the Clinical Core and its outstanding partners can recruit research participants nationally and internationally. In one smartphone study, over 15,000 individuals nationally enrolled in seven months, and in another, we recruited 1600 participants from ~13 countries. The Clinical Core will be led by Dr. Giovanni Schifitto, a NIH-funded investigator who has helped lead multiple large-scale clinical research efforts, and will be supported by a cadre of junior and senior clinical investigators with extensive experience conducting remote and in-person research evaluations. The Core will also include John Wilbanks, the Chief Commons Officer at Sage Bionetworks and one of the country’s leading thinkers and practitioners of informed consent, to help guide the Center’s multiple remote studies. Supported by experts in project and data management, the Clinical Core is poised to be an outstanding resource for the UR-Udall Center, the network of Udall Centers, and the broader PD community.
The Administrative Core at the Udall Center at the University of Rochester will utilize the established resources of the University of Rochester’s Center for Health + Technology (CHeT). Over the past 25 years, CHeT has pioneered multi-center research studies that have enrolled 40,000 individuals in 120 studies that have led to seven FDA-approved therapies, including four for PD. More recently, CHeT has used technology to transform PD research and care.Among these PD initiatives are disease models that have identified novel clinical and genetic markers of disease progression, the first two virtual PD research studies, the two largest smartphone studies in PD, the first longitudinal wearable sensor study for PD, and the only national randomized controlled trial of telemedicine for PD.