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Bethesda North Marriott Hotel and Conference Center

23 abr 2018 1:00 p.m. - 25 abr 2018 4:15 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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 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:

  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?

Speaker(s)

Kevin J. Anstrom, PhD

Risk-Based Monitoring – A Local Experience

Kevin J. Anstrom, PhD

Duke Clinical Research Institute, United States

Associate Director of Biostatistics

Martin  Landray, PhD, FRCP

Speaker

Martin Landray, PhD, FRCP

Protas, United Kingdom

Chief Executive

Eric  Genevois-Marlin, MSc

Panelist

Eric Genevois-Marlin, MSc

Sanofi R&D, France

Vice President, Biostatistics and Programming

Timothy E Rolfe

Panelist

Timothy E Rolfe

GSK, United Kingdom

Director, Risk Based Monitoring

Jennifer  Schumi, PhD, MS

Panelist

Jennifer Schumi, PhD, MS

Teva Pharmaceuticals, United States

Global Statistics TA Head, Immunology/Biosimilars

Jean M. Mulinde, MD

Panelist

Jean M. Mulinde, MD

FDA, United States

Associate Director, Division of Clinical Compliance Evaluation, OSI

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