The Use of Real World Data as a Bayesian Prior in a Device Clinical Trial

• Activity Number: 575 - Translating Real World Data into Robust Evidence to Inform Decisions on Medical Product Development and Life Cycle Management
• Type: Topic Contributed
• Date/Time: Wednesday, August 1, 2018 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Roseann White*
• Companies: Duke Clinical Research Institute

Abstract

There are numerous registries that collect device performance data in clinical practice, e.g. CathPCI Registry, STS Registry, TVT registry. In some cases, such as the STS database, a model has been develop to estimate the risk of a mortality or morbidity event based on baseline characteristics. Others provide outcome information on the population of interest. This presentation will present an example of using each type as a Bayesian prior. The first example with application of the STS model and a Bayesian prior in a trial for a device to address mitral valve regurgitation. The second example will be use the VQI database as a Bayesian prior for a device to restore patency in the SFA. In both cases, the process described in Haddad, et. al., J Biopharm Stat. 2017; 27(6):1089-1103 when applying the Bayesian prior.