Pacific C
Industry experience in applying the discount power prior (306638)
*Theodore Lystig, MedtronicKeywords: real world data, 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; real world 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 is working to develop methods and align upon processes for incorporating external evidence into medical device submissions (and evaluation of such submissions). 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 industry experience in developing and applying the discount power prior in regulatory settings, using real examples.