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Activity Number:
370 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Tuesday, July 31, 2018 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330530
Title: Bayesian Methods in Real-World Evidence for Medicinal Product Development: Can Prior Distributions Provide a Platform for Creating Real-World Evidence?
Author(s): John Loewy*
Companies: Dataforethought
Keywords: Bayesian Methods; Real World Evidence; Meta-Analysis; 21st Century Cures Act; Drug Development; adaptive designs

The "21st Century Cures Act" (T21CCA) was signed into law in November of 2016. The ideas expressed under Subtitle C-Modern Trial Design and Evidence Development are at the forefront to motivate transforming real world data (RWD) into Real World Evidence (RWE) for medicinal product development. To that end Bayesian statistical methods (BSM) are well suited to the RWE paradigm envisioned in T21CCA. Clinical trial designs using BSM already use information derived from RWD or data from previous randomized clinical trials (RCTs) to determine whether a new product being tested is safe and efficacious. Innovation leading to potential breakthrough medicinal products will continue to occur. BSM are the lynchpin capable of combining prior knowledge (data from RWD or previous RCT) with new product data captured to examine the merits of transforming the results obtained into RWE. When implemented with scientific rigor, can such a Bayesian design establish decision criteria to inform us more quickly with less subjects studied whether the clinical evaluation goals of the study have been met? Real-world examples will be presented to motivate discussion.

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

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