Monitoring Adap-ve Clinical Trials a Case Study

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Avoidance of Operational Bias• Guidance documents by FDA and EMA for DMC and Adap-ve Trial Design: – Reference the importance of confiden-ality of interim results – Require that well-‐trusted firewalls are established for trial conduct to provide assurance that opera-onal biases have not been introduced. – Requests an accurate recording of trial conduct and documenta-on – who saw what and when ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 10
Avoidance of Operational Bias• Must provide auditable evidence that GSD/SSR was strictly followed and based only on the pre-‐specified decision rule • Ensure that firewalls were in place to protect unblinded analyses • Show evidence that Sponsor was not involved in ISC and DMC interac-ons and was not exposed to unblinded IA results ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 11
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 and 8: The Promising Zone Design• Par--o
Page 9: Data Monitoring Committee• DMC r
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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