Best Practice Subteam

Leader Information

Name Email
Fanni Natanegara
Cory Heilmann

SubTeam Overview

The increase in use and acceptance of Bayesian methodology in clinical trials has led to a need for guidance on how to report and document such methodology. ICH and various regulatory agencies recommend including language regarding the planned analyses for primary and other key analyses in the protocol and in a pre-specified analysis plan. This subteam’s goal is to provide recommendations on the level of detail to include in protocols and analysis plan as well as simulation plan involving Bayesian designs and analyses.

Ongoing Projects

  • TBD