Real World Evidence Core

Real-World Evidence Core (RWE) - Summary The Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub will serve as a national resource for multidisciplinary expertise and knowledge in maternal and pediatric therapeutics. Women and children were historically excluded from and continue to be under-represented in clinical research studies, leading to a

scarcity of knowledge relating to pharmacokinetics and pharmacodynamics of therapeutic agents in these populations. The IU-OSU MPRINT will identify data relevant to understanding maternal and pediatric physiology, pharmacology, and clinical outcomes from literature, public resources, and MPRINT collaborators,

integrate data into pharmacometrics models to enhance knowledge and understanding of drug disposition and response and support drug development and therapeutics in maternal and pediatric populations. To accomplish this, the Real-World Evidence (RWE) Core brings together experts and resources from the

Regenstrief Institute (Regenstrief), Indiana University, the Indiana Health Information Exchange (IHIE), and Information Technology groups across our partner healthcare systems in collaboration with Nationwide Children’s Hospital and Ohio State University. By leveraging and building upon our team’s expertise and

robust data resources, we will support MPRINT investigators to characterize, study and address research questions on maternal and pediatric physiology, pharmacology, and clinical outcomes, including social and disparities issues, with the ultimate goal of enhancing drug safety and efficacy in maternal and pediatric

patients by understanding inter-and intra-individual sources of variability. This environment is essential to supporting T2 (to patients), T3 (to practice), and T4 (to population) translational research in maternal-pediatric precision therapeutics, particularly in emerging and multidisciplinary scientific areas.

The Specific Aims of the Core are: 1) Create a collaborative consortium of RWE for the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub by providing an effective governance structure and shared infrastructure; 2) Integrate and facilitate secure and efficient access to diverse, high-quality RWE datasets and

informatics solutions to support and accelerate clinical and translational science in pharmacokinetics and pharmacodynamics of therapeutic agents in these populations; and 3) Advance informatics innovation, knowledge, and best practices to accelerate T2 to T4 maternal-pediatric precision in therapeutics.

The Core will bring innovations in many areas in data management and data analytics, technology, clinical and translational informatics. Led by Drs. Mendonça and Lin, the RWE, will support the MPRINT Center cores, and all Center members will be eligible to leverage the data and analytic support afforded by the Core.