Monitoring Adap-ve Clinical Trials a Case Study

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Access Control Execution System(ACES)• ACES is a secure, web-‐based system used during the interim analysis to: – Centrally store interim analysis reports, mee-ng agendas and minutes, and DMC recommenda-ons – Assign team members to specific roles and grant explicit privileges to securely access data and informa-on ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 12
Traditional ProcessSponsor Create Documents (Protocol, SAP, DMC Charter) Store/Archi<strong>ve</strong> Documents Enroll Subjects & Collect Responses Send Response Data to ISC ISC Request additionalinformationSend Analysis to DMC Perform Analysis and Create Reports Create and Test Analysis Programs DMC Send Recommenda-on to Sponsor/ Steering Commitee Make Recommenda-on Steering Commitee Make Decision About Trial Ager decision… 1. DMC no-fied 2. Drug Supply no-fied 3. IVRS no-fied ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 13
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 and 10: Data Monitoring Committee• DMC r
Page 11: Avoidance of Operational Bias• Mu
Page 15 and 16: Summary: Design• The adap-ve de
Page 17: Summary: Process• Integrated Sys

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