Monitoring Adap-ve Clinical Trials a Case Study

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Adaptive Decision RuleInterim analysisat ~187 events:Interim AnalysisPlanned EndC effY%EfficacyFavorablePromising Zone (add 225 patients)X%C futUnfavorableFutilityCPCP = Conditional powerThe probability of success (statistical significance) at the end of the trial given current data trendInterim outcome par--oned into unfavorable, promising, and favorable zones ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 8
Data Monitoring Committee• DMC responsible for monitoring both, safety and efficacy • DMC may call for sample size increase only if interim result falls into Promising Zone ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 9
Page 1 and 2: Monitoring Adap-ve Clinical Trial
Page 3 and 4: Presentation Contents• Study Des
Page 5 and 6: Sponsor’s Dilemma• Based on p
Page 7: The Promising Zone Design• Par--o
Page 11 and 12: Avoidance of Operational Bias• Mu
Page 13 and 14: Traditional ProcessSponsor Create D
Page 15 and 16: Summary: Design• The adap-ve de
Page 17: Summary: Process• Integrated Sys

Monitoring Adap-ve Clinical Trials a Case Study

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