Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development

    Basic Details
    Date Posted
    Tuesday, December 13, 2022
    Status
    Protocol in preparation
    Description

    Sequential surveillance of therapeutics in electronic health data enables routine monitoring for a statistically significant increased risk of specific adverse events. When performing sequential surveillance of drug safety, a formal study is designed and repeated as data accrues to identify any increased risk for outcomes of interest as quickly as possible. This monitoring is continued until 1) there are findings that indicate that a safety issue may be present and therefore more follow-up or a regulatory action is warranted, or 2) until findings provide assurance that the safety issue of interest does not require further action.


    The Sentinel System has integrated the capability to perform sequential surveillance into its routine analytic tools. The tools have the ability to perform multiple executions of cohort or self-controlled risk interval analyses. This project aims to leverage these capabilities to assist FDA in their response to the COVID-19 pandemic – specifically monitoring safety of new therapeutics. A master protocol will be designed such that it can be leveraged to proactively monitor the safety of these therapeutics as they undergo FDA review and are introduced to the market. 

    Information
    Data Source(s)
    Sentinel Distributed Database
    Workgroup Leader(s)

    John Connolly, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Member(s)

    Sruthi Adimadhyam, PhD, MS; Meredith Epperson, MScPH; Joy Kolonoski, MPH; Judith C. Maro, PhD, MS; Andrew Petrone, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Maya Beganovic, PharmD, MPH, BCIDP; Trish Bright, PhD, MSPH; Sarah Dutcher, PhD, MS; Efe Eworuke, PhD; Jose Hernandez, RPh, MPH, MSc, PhD; Yong Ma, PhD, MS; Sukhminder Sandhu, PhD, MPH, MS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

    James Antoon, MD, PhD, MPH; Department of Pediatrics, Monroe Carell Jr Children's Hospital at Vanderbilt and Vanderbilt University Medical Center, Nashville, Tennessee, USA