The TSC Alliance has recently contributed data to The Rare Disease Cures Accelerator–Data and Analytics Platform (RDCA-DAP), funded by the U.S. Food and Drug Administration and developed by the Critical Path Institute and the National Organization for Rare Disorders. The RDCA-DAP is a neutral, independent data collaboration providing an integrated database and analytics hub that is designed to be used in building novel tools to accelerate drug development across rare diseases. RDCA-DAP promotes the sharing of existing patient-level data from diverse sources, including clinical trials, longitudinal observational studies, patient registries and real-world data (e.g., electronic health records) across a multitude of rare diseases. Data are, and will continue to be, contributed from different organizations and companies around the world and may include genomic data, imaging data and information about other novel biomarkers and outcome measures as well as clinical data. By integrating available data from our existing Natural History Database, the RDCA-DAP will help to accelerate the understanding of disease progression, clinical outcome measures and biomarkers, and facilitate the development of mathematical models of disease and innovative clinical trial designs across all rare diseases.

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