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.
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- A recent draft guidance of FDA on Risk-Based Approach to Monitoring states: “FDA encourages greater reliance on centralized monitoring practices than has been the case historically,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:
