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DIA/FDA Biostatistics Industry and Regulator Forum

Session 8: Risk-Based Monitoring

    Session Chair(s)
      Nevine  Zariffa

      Nevine Zariffa

      • Vice President and Head Biometrics & Information Sciences
      • Astrazeneca Pharmaceuticals, United States
      Mat  Soukup, PhD

      Mat Soukup, PhD

      • Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER
      • FDA, United States

    The recent ICH E6 now includes explicit recognition that centralized monitoring can/should be part of the quality system for trials with the aim of identifying missing data, inconsistencies, outliers, and a lack of variability. The use of statistics is encouraged to identify trends, looking at the range and consistency of data across sites. The current approach of 100% source data verification would thus be replaced by these newer contemporary techniques.

    While the principles are clear, implementation requires careful consideration and expert trialists have different views. The session will explore some of the key challenges in fully embedding risk based monitoring. Key topics include:

    1. Should we monitor primary endpoints directly, indirectly, or not at all?
    2. Should general rates of AEs by site or country be monitored and evaluated for unusual patterns?
    3. Should we concentrate of operational dashboards for completeness of data, aggregate data at the patient level, or site/regional patterns?
    4. What is the role of statistical pattern detection?
      Kevin J. Anstrom, PhD

      Risk-Based Monitoring – A Local Experience

      Kevin J. Anstrom, PhD

      • Associate Director of Biostatistics
      • Duke Clinical Research Institute, United States
      Martin  Landray, PhD, FRCP


      Martin Landray, PhD, FRCP

      • Professor of Medicine & Epidemiology, Nuffield Department of Population Health
      • University of Oxford, United Kingdom
      Eric  Genevois-Marlin, MSc


      Eric Genevois-Marlin, MSc

      • Vice President, Biostatistics and Programming
      • Sanofi R&D, France
      Timothy E Rolfe


      Timothy E Rolfe

      • Director, Risk Based Monitoring
      • GSK, United Kingdom
      Jennifer  Schumi, PhD, MS


      Jennifer Schumi, PhD, MS

      • Statistical Science Director
      • AstraZeneca Pharmaceuticals LP, United States
      Jean M. Mulinde, MD


      Jean M. Mulinde, MD

      • Senior Policy Advisor, Office of Scientific Investigations, OC, CDER
      • FDA, United States