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PSI Conference 2018: A Bayesian Approach to Augment Active Comparator Efficacy Information with Historic Randomized Clinical Trial Data in a Non-Inferiority Trial

05 June 2018

In the Phase 3 development of a 3-DAA (direct-acting antiviral) combination for treatment of chronic hepatitis C, an innovative Bayesian design was proposed for establishing non-inferiority to standard of care (SOC). Combining direct evidence from the data in the current trial, with indirect information that is borrowed from historic data, allows to design more cost effective and efficient clinical studies. The augmentation of the SOC arm with historic efficacy information from publicly available clinical trials was proposed to efficiently use the available data for the SOC, as well as the information from treated patients in the new trial. Challenges were the selection of historical clinical trials, the proportion of borrowed data and the decision rule to declare non-inferiority that ensures type 1 error control. In the current trial, simulations were an integral part of the design development and justification to regulators. Positive feedback was received from the FDA.

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