EMA Hosts Workshop on Subgroup Analysis

The conclusions of the workshop will be considered when drafting the proposed EMA guideline on subgroup analysis.

The European Medicines Agency recently assembled for the first time some 50 experts in subgroup analysis from Europe and the U.S., in a one-day scientific workshop.

Subgroup analyses are an important tool in the assessment of confirmatory trials in marketing authorisation applications, and appropriate statistical methods are key for a sound clinical interpretation of subgroup results.

The Committee for Medicinal Products for Human Use (CHMP) is currently preparing an EMA guideline with important methodological considerations, assessment strategies and some example datasets. The aim of the workshop was to present the scope and content of the proposed guideline to internal and external experts, and to receive feedback f