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Abstract:
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Virtually all scientists would agree that, everything else being equal, randomized study designs have stronger internal validity than comparable observational study designs. But in what situations can observational studies provide reliable evidence for guiding treatment decisions and policy choices? The reliability of evidence from observational studies has received national attention as a result of recent legislation mandating that the FDA develop a framework for including Real World Evidence (RWE) in safety surveillance, as well as in approving new indications for previously approved products. This talk will examine historical perspectives on the reliability of evidence from observational studies and describe an exciting new OptumLabs research collaboration that could break new ground in studying the replicability of clinical trials.
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