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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 #300414 Presentation
Title: External Evidence: Latest Developments from the Eponymous Medical Device Innovation Consortium Working Group
Author(s): Theodore Lystig*
Companies: Medtronic
Keywords: real world evidence; hierarchical model; power prior; performance goal; propensity score; modeling and simulation

In the context of a given clinical trial, external evidence refers to information originally generated outside that trial but used in a combined analysis with data generated within the trial. Examples of external evidence include: data from several historical trials used with the current trial in a hierarchical model; data from a disease registry used to construct a performance goal against which results from a one-armed trial are to be compared; or modeling and simulation data used to create an informative power prior for the current trial. The External Evidence working group from the Medical Device Innovation Consortium has two main deliverables: creation of a catalog of (non-exhaustive) case examples detailing endorsed methods for different data types to meet certain objectives, and production of a decision tree outlining key steps for interactions between sponsors and regulators when working with external data. While this work is being driven by the medical device community, it has broad applicability to other areas such as biologics and pharmaceuticals. In this talk I will present the progress to date of the External Evidence team and outline next steps.

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

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