Informatics Core

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PROJECT SUMMARY OF THE INFORMATICS CORE Natural product (NP)-drug interaction (NPDI) research spans several disciplines that include sourcing and characterizing candidate NP materials (Analytical Core), in vitro and clinical assessment of NPDI liability (Pharmacology Core), and data dissemination (Informatics Core). The existing Center of Excellence for NPDI Research (NaPDI Center), currently in its fifth successful year, consists of world-renowned experts in each of these areas and provides leadership for NPDI research. The Informatics Core has created a cloud-based data repository that provides a secure workflow for manual NPDI study data entry and publishing. The repository is a leading example of how to make NPDI data findable, accessible, interoperable, and reusable (FAIR). The long- term sustainability of the data repository is dependent on its usefulness to relevant stakeholders. The Informatics Core component of this renewal application proposes three SPECIFIC AIMS that refine the data repository and expand the informatics power of the NaPDI Center. AIM 1: The Core will add features to the data repository to increase its usefulness for a growing community of NPDI researchers, including companion R21 grantees. Such features include a streamlined external data submission process based on simple-to-use data entry forms and web services that use a common data format. New data summaries and visualizations will provide researchers a complete evidence-based overview of each NP’s potential to precipitate pharmacokinetic NPDIs. AIM 2: The Pharmacology Core previously developed a highly effective and robust method, termed the fulcrum model, for selecting and prioritizing NPs as potential precipitants of NPDIs. Application of this novel model is currently a time-consuming manual task. The Informatics Core will innovate the fulcrum model by developing an informatics- based method to expedite the collection and summarization of data needed to apply the fulcrum model, providing an automated and continual appraisal of high priority NPs to the Center and external NP researchers. The Core will also innovate the identification of NPs by generating pharmacovigilance signal data for NPs using data from poison center reports and two FDA adverse event reporting systems. This new feature will provide researchers with important insight into the types of reported adverse events and concomitant exposures involving NPs. AIM 3: The Informatics Core will broaden the usage and utility of the data repository for both the research community and clinical practice stakeholders. To capture scientists across the spectrum of disciplines in NPDI research, we will expand our marketing strategy. To capture clinical practice stakeholders who consider potential NPDIs during medication ordering and reconciliation activities, we will design NPDI clinical decision support artifacts and services through a user-centered approach inspired by recent advances in decision support for potential drug- drug interactions. Accomplishment of these aims will result in a learning NPDI research system that will improve public health by helping patients avoid NPDIs.