Topic

primary-endpoints

Primary endpoint definition and decision consequences.

Endpoint Strategy

FDA Surrogate Endpoint Table: How to Use It Without Assuming Qualification

How clinical development teams can evaluate FDA's surrogate endpoint table across indication, mechanism, and approval pathway without conflating listing with formal qualification.

Sep 1418 minBy Ran Chen

Estimands & Statistics

Multiple Endpoints in Clinical Trials: Hierarchy, Co-Primaries, and Error Control

A rigorous analysis of multiplicity management in clinical trials, comparing FDA's 2022 final guidance and EMA's 2002 Points to consider across co-primaries, hierarchies, and gatekeeping.

Aug 279 minBy Ran Chen