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Institutional Oversight Of Clinical Trials And The Drug Approval Process, Paul B. Miller

Osgoode Hall Law Journal

The institutional and federal bodies responsible for regulatory review and oversight of clinical trials in Canada serve distinct yet complementary functions in ensuring that clinical trials provide scientifically rigorous and ethically sound evaluation of new therapeutic products. To date, academics and reformers alike have discussed reform priorities for federal and institutional review in isolation, as if their guiding purposes are distinct. This article identifies the overlapping objectives of federal and institutional review, argues for the importance of coordination of institutional and federal oversight structures, and identifies potential points of coordination.