Monitoring Adap-ve Clinical Trials a Case Study

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Summary: Process• Use of technology to control flow of informa-on between sponsor, independent sta-s-cal center and DMC – DMC portal for storage of sensi-ve documents – Interim analysis report generated and stored in DMC portal without possibility of external interven-on – Audit trail of access to all reports stored in the DMC portal to track ”who saw what and when” ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 16
Summary: Process• Integrated Systems can increase efficiency in the flow of data and informa-on, and how groups communicate • Opera-onal Bias is greatly reduced by using secure systems, and by limi-ng access to unblinded data • Trial Integrity is protected by documen-ng the conduct, logis-cs, and opera-on of the trial through security and audit trails • Regulatory Confidence in the consistent execu-on of adap-ve trials by implemen-ng systems that enforce ‘best prac-ce’ processes ©2012 Cytel Inc. JSM 2012; July 28 -‐ August 2, 2012 17
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 and 12: Avoidance of Operational Bias• Mu
Page 13 and 14: Traditional ProcessSponsor Create D
Page 15: Summary: Design• The adap-ve de

Monitoring Adap-ve Clinical Trials a Case Study

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