Monitoring Adap-ve Clinical Trials a Case Study
Monitoring Adappve Clinical Trials; a Case Study - Cytel
Monitoring Adappve Clinical Trials; a Case Study - Cytel
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Summary: Design• The adap-<strong>ve</strong> design mi-gates risk of ini-al o<strong>ve</strong>r-‐in<strong>ve</strong>stment, and risk of failing to detect a relevant survival benefit • Sta-s-cal rigor: theore-cal and simula-on-‐based guarantee that Type-‐I Error is controlled • DMC may call for sample size increase only if interim result falls into Promising Zone • <strong>Study</strong> design pre<strong>ve</strong>nts from back-‐calcula-on of treatment effect • This design sa-sfies both sta-s-cal and opera-onal requirements s-pulated in FDA Drag Guidance and in EMA Reflec-on Paper on <strong>Adap</strong>-<strong>ve</strong> Design <strong>Clinical</strong> <strong>Trials</strong> ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 15
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