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Activity Number: 108 - New Era for Safety Evaluation
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #328478 Presentation
Title: Propensity-Score-Based Controls: Its Use in Establishing Benefit/Risk of Medicines for Unmet Medical Need
Author(s): Junjing Lin* and Margaret Gamalo-Siebers and Ram Tiwari
Companies: AbbVie and Eli Lilly & Co and Center for Devices and Radiologica Health, FDA
Keywords: Bayesian augmented control; exchangeability; propensity score; historical control

In drug development, the control of type-I error is important as the consequence of approving a drug that is not efficacious can potentially cause public harm. Generally, control of type-I error is translated to being able to estimate the effects of treatments accurately in a randomized controlled trial (RCT). The concept of an informative data-based prior then are sometimes at odds with the rigor instituted by RCTs. To mitigate this problem apart from just using objective priors, the concept of exchangeability needs to be considered, i.e., the trial can be assumed to be exchangeable with other previous trials when the previous trials are considered to be good prior information. What this concept also implies is that the choice of the prior necessitates a sound exploration and synthesis of information from multiple sources at various stages. In this talk, we use the propensity scoring technique and explore strategies how historical data can be used effectively to form a basis for drug approval.

Authors who are presenting talks have a * after their name.

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