Priority topics

Currently, the EFSPI methods leaders are working on five priority topics. These are aligned with overall EFSPI priorities.

Application of Bayesian methods in drug development.

Covariate adjustment.

A framework to appraise statistical methods building on ICH M15.

Specific topics related to estimands.

These topics are aligned with both EFSPI and EFPIA and input from further stakeholders, e.g. the EFSPI / PSI SIGs, is sought as well. The idea is to be prepared for discussions with regulators once there are opportunities, e.g. within EMA multistakeholder workshops.

AI