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Activity Number: 111 - Evidence Beyond Traditional Clinical Trials
Type: Invited
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #300422
Title: Recent Statistical Developments in Considering Real World Evidence for Regulatory Decisioin Making
Author(s): Martin Ho* and Weili He
Companies: FDA and AbbVie
Keywords: real-word evidence; FDA; real-world data; RWE; RWD

Increasing number of real-world data (RWD) sources (e.g., EHRs, claims data, registries) have become readily available. Although experts from multiple disciplines have been actively exploring and developing ways to utilize Real-World Evidence (RWE) to fill the gaps in current clinical trial enterprise, the statistical community has yet to reach consensus on how to measure the potential bias and level of uncertainty of the new class of synthesized evidence. In 2018, the ASA BIOP Section RWE Scientific Working Group (SWG) was chartered to explore using statistics to transform RWD into RWE to inform regulatory decisions of medical products. The SWG has 2 work streams and they have been focusing on using RWE: (a) to modify existing labels of medical products and (b) to inform better clinical study designs. In this presentation, early study results of the SWG will be presented. First, the current statistical landscapes will be described, followed by discussion of some examples. The presentation will be concluded with some identified topics where the SWG can make most substantial impacts and future research agendas.

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

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