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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

    Basic Details

    Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines.


    Sebastian Schneeweiss MD, ScD, Hans Georg Eichler MD, MSc, Anna Garcia-Altes, Chris Chinn, Anne-Virginie Eggimann, Sarah E. Garner, W. Goettsch, Robyn R. Lim, W. Löbker, David Martin MD, MPH, T. Müller, B.J. Park, Richard Platt MD, MSc, Sarah A. Priddy, Michael Ruhl, Almoth Spooner, B Vannieuwenhuyse, Richard J Willke

    Corresponding Author

    S. Schneeweiss, Division of Pharmacoepidemiology (DoPE), Department of Medicine, Brigham & Women's Hospital, Boston, Massachusetts, USA. Email: