Central Statistical Monitoring of Clinical Trials

April 19, 2012

IDDI organized a webinar on Statistical Approach to Central Monitoring of Clinical Trials

This webinar presented the underlying principles of a statistical approach to central monitoring.
The speakers  illustrated typical findings obtained with this approach in actual trials from different therapeutic areas. They also briefly discussed alternatives, such as the use of key‑risk indicators.

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Central Statistical Monitoring of Clinical Trials

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Contents:

  • A recent draft guidance of FDA on Risk-Based Approach to Monitoring states: “FDA encourages greater reliance on centralized monitoring practices than has been the case historically, with correspondingly less emphasis on on-site monitoring”. This webinar presented the underlying principles of a statistical approach to central monitoring.
    The speakers  illustrated typical findings obtained with this approach in actual trials from different therapeutic areas. They also briefly discussed alternatives, such as the use of key‑risk indicators.

Speakers:

  • Prof Tomasz Burzykowski, VP of Research at IDDI since 2009. Tomasz is Research Professor of Biostatistics/Bioinformatics at the Center for Statistics of Hasselt University since 2002 and serves as Associate Editor for Biometrics.
  • Yves Tellier, Head Clinical Data Management, GSK Biologicals. Yves has been working for 15 years in GlaxoSmithKline Biologicals (vaccine division of GSK) in the area of Clinical Data Management and heading the team for 13 years. He is a regular speaker at DIA Meetings to present technology breakthroughs related to EDC, safety data collection, globalisation, off-shoring,…

 

Presentation of the Webinar : Central Statistical Monitoring of Clinical Trials

To access the presentation of this on-demand webinar, please fill out this form.

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