The Past Is Prologue: The Use of Prior Information and Bayesian Methodologies in Designing Medical Device Regulatory Approval Trial

• Activity Number: 382 - Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments
• Type: Invited
• Date/Time: Tuesday, August 1, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Roseann White*
• Companies: Pragmatic clinical trial Statistics, Duke Clinical Research Institute

Abstract

There have been many paper on the advantages and disadvantages of the Bayesian power prior in clinical trials. However, there have been several roadblocks to the acceptance of this methodology when planning medical device feasibility and approval clinical trials that are required regulatory approval in key geographies. Some of the challenges that MDIC has trying to address are the following:

1. Clarifying for the clinical community does it mean to design a clinical trial where one can combine the prior information about the device with the current trial data to improve the precison in the outcome estimates or potentially reduce the sample as compared to a frequentist approach 2. Clarifying what is expected by CDRH when putting together a protocol so that the review and approval process goes smoothly 3. Developing a transparent process that allows one to pre-specify how the prior information will be weighted based on type I error, assuring that the bias that will be introduced by the prior is clinically acceptable and the probability of success of the trial given the assumed true outcome is acceptable (the loss function).