TL08: Real-World Data and Historical Control to Augment Medical Devices Clinical Trials

Music City Center 

Leveraging Real World Data (RWD) in the development plan of medical devices is a highly desirable proposition to augment a prospectively designed clinical trials. Another area related to the us of external data is the opportunity to use historical control data to increase efficiencies both in terms of sample size and costs reduction. Proper statistical methods need to be applied to reduce bias and properly estimate the device benefit/risk depending on the sources of data to be integrated. Such method include for example propensity scores, meta-analyses weighting approach, and Bayesian power priors. This roundtable aims to share experiences and discuss some approaches with concrete implementation examples.

Medical devices

Real World Data

historical control

propensity scores

meta-analysis

Bayesian priors 

Section on Medical Devices and Diagnostics