Monitoring Adap-ve Clinical Trials a Case Study

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The VALOR Trial for AML• Vosaroxin and Cytarabine combina-on evalua-ng Overall Survival in relapsed/refractory Acute MyeloidLeukemia (AML) • Phase 3, double-‐blind, placebo-‐controlled, mul-na-onal trial • Design for 90% power at 5% significance level ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 4
Sponsor’s Dilemma• Based on phase 2 data (N=69): – Assume 5/7 month median on Ctrl/Trtm (HR=0.71) – Require 375 events and 450 subjects @ 19/month • But phase 2 es-mates are subject to uncertainty: – What if 5/6.5 month median on Ctrl/Trtm (HR=0.77)? – HR = 0.77 is s-ll clinically meaningful – Require 616 events and 732 subjects @ 31/month – Not a feasible op-on for sponsor ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 5
Page 1 and 2: Monitoring Adap-ve Clinical Trial
Page 3: Presentation Contents• Study Des
Page 7 and 8: The Promising Zone Design• Par--o
Page 9 and 10: Data Monitoring Committee• DMC r
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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