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Emerging Issues in Risk Based Monitoring
Session Chair(s)
Andrew Thomson, PhD, MA, MS
Statistician, Methodology Taskforce
European Medicines Agency, Netherlands
Conducting a clinical trial is a risky business. Risk based monitoring is a phrase that can mean different things to different people. The session will focus on two different but important areas. Firstly, how clinical trials can be monitored in a proportional fashion, how risk-based approaches might be adopted, and how new legislation facilitates that. Secondly, how clinical trials can and should be monitored so that risks to the integrity of the trial are picked up, and crucially how statisticians should be involved in the process. The session will conclude with a round table discussion to discuss the issues raised with the wider audience.
Speaker(s)
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
Funnels Plots as a Risk Based Monitoring Tool
John D Davies
GlaxoSmithKline Inc., United Kingdom
Records Manager
Martin Landray, PhD, FRCP
Protas, United Kingdom
Chief Executive
Marc E. Buyse, DrSc
IDDI, United States
Chief Scientific Officer
Challenges with Statistical Validation of Metrics for Risk-Based Monitoring: Reflections on a pilot study
Erika Daly
ICON Clinical Research, Ireland
Manager Biostatistics & Programming
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