Abstract:
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The NIH continues to expand the number of their clinical trials networks (CTNs). This is due to the successful and efficient clinical trials conducted by the networks, and more importantly, the recognition of the numerous innovations in clinical trials design, conduct and analysis developed in such settings. CTNs commonly consist of a clinical coordinating center (CCC), a data coordinating center (DCC) and several recruitment centers, all set within academic medical institutions. The DCCs provide a comprehensive statistical and data management infrastructure for conducting high quality research that will improve outcomes for patients. This infrastructure allows not only for the rapid conduct of rigorous clinical trials, but also for development and implementation of novel study designs, including studies for discovering and validation of biomarkers, master protocols and platform trials. Statisticians face exciting methodological challenges that have deep implications for shaping the future of medical research. In this roundtable discussion, seasoned statisticians will share stories about their professional growth and personal achievements resulting from their involvement in DCCs.
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