Online Program

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Wednesday, September 25
Wed, Sep 25, 1:15 PM - 2:30 PM
Historical Data Borrowing in Clinical Trial Design and Analysis

Borrowing Strength from Historical Data in Clinical Trials: A Thirteen-Year Review (300994)

*David Ohlssen, Novartis 

Keywords: Bayesian methods, historical data, meta-analytics predictive prior

My first experience in the pharmaceutical industry was on a meeting to discuss a Bayesian approach that would allow historical data to be used as a prior in clinical trial analysis. Using this as a starting point, a review of the progress on the use of historical data in clinical trials within a large pharmaceutical company will be presented. In particular, I will look at how this was brought into practice through methods developed, training and software. Several examples will be reviewed, including use within early phase proof of concept studies and pediatrics. Finally, we will report back on a recent experience in the confirmatory setting with the FDA complex innovative design (CID) pilot.