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Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data

    Basic Details

    This article describes challenges in conducting sequentially monitored medical product safety surveillance evaluations using observational electronic data captured during routine care. The paper reviews existing sequential approaches for potential use in this setting.


    Jennifer C. Nelson PhD; Andrea J. Cook PhD; Onchee Yu MS; Clara Dominguez; Shanshan Zhao; Sharon K. Greene PhD, MPH; Bruce H. Fireman MA; Steven J. Jacobsen; Eric S. Weintraub; Lisa A. Jackson MD, MPH

    Corresponding Author

    J. C. Nelson, Biostatistics Unit, Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA. E-mail: