Bayesian Gets A Boost With Guidance, But Technique Still Not For Everyone
This article was originally published in The Gray Sheet
The complex calculations of Bayesian statistics are not likely to become standard for FDA device submissions anytime soon, but they could help streamline clinical trials in many more instances, CDRH's top statistics official says
You may also be interested in...
Adaptive device clinical trials, where study is designed in anticipation of midstream changes, are the focus on a new FDA draft guidance. Adaptive trials can reduce the duration and cost of a study without undermining its integrity, but the practice should be applied with caution, FDA says.
More collaboration between device companies and with FDA will be needed to employ sophisticated "virtual patient" computer models to reduce the number of patients needed in clinical trials, says Medtronic statistician Tarek Haddad.
FDA's device center issued draft guidance on leveraging existing adult – and some pediatric – clinical data for extrapolation to pediatric uses of devices. It provides a decision tree for device sponsors to help determine if available data is suitable to demonstrate safety and effectiveness in a younger population.