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Session 8: Risk-Based Monitoring
Session Chair(s)
Nevine Zariffa
Vice President and Head Biometrics & Information Sciences
Astrazeneca Pharmaceuticals, United States
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, 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:
- Should we monitor primary endpoints directly, indirectly, or not at all?
- Should general rates of AEs by site or country be monitored and evaluated for unusual patterns?
- Should we concentrate of operational dashboards for completeness of data, aggregate data at the patient level, or site/regional patterns?
- What is the role of statistical pattern detection?
Speaker(s)
Risk-Based Monitoring – A Local Experience
Kevin J. Anstrom, PhD
Duke Clinical Research Institute, United States
Associate Director of Biostatistics
Speaker
Martin Landray, PhD, FRCP
Protas, United Kingdom
Chief Executive
Panelist
Eric Genevois-Marlin, MSc
Sanofi R&D, France
Vice President, Biostatistics and Programming
Panelist
Timothy E Rolfe
GSK, United Kingdom
Director, Risk Based Monitoring
Panelist
Jennifer Schumi, PhD, MS
Teva Pharmaceuticals, United States
Global Statistics TA Head, Immunology/Biosimilars
Panelist
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI