Health Affairs March 26, 2020
Christopher J. Morten, Amy Kapczynski, Harlan M. Krumholz, Joseph S. Ross

To address the COVID-19 pandemic that is bearing down on the United States, the public urgently needs new diagnostics, treatments, and vaccines. However, to be confident that any new technologies are safe and effective, we need public access to clinical research data and other information on these technologies. As President Trump, Congress, the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the National Institutes of Health (NIH), and other parts of government move quickly to fight COVID-19, they should make clinical research data transparency a high-level priority and commit to data sharing as a condition of clinical research funding and product clearance and approval. Medical journals should help by mandating data sharing associated with publications on therapeutics,...

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Topics: Biotechnology, FDA, Govt Agencies, HIE (Interoperability), Patient / Consumer, Pharma, Technology
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