EFSPI statistical methodology leaders

Introduction

In September 2023 EFSPI founded a new group EFSPI statistical methodology leaders, bringing together methodology leaders to work on topics of common interest.

Find more context in this linkedin post and this slidedeck.

Members

A list of current members is available here.

Previous events

Materials from events the methods leaders contributed to are available here.

Priority topics

In Q1 2025, four priority topics have been defined by the methods leaders:

1. Application of Bayesian methods in drug development.
2. Covariate adjustment.
3. A framework to appraise statistical methods building on ICH M15.
4. 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.

Newsletters

3rd March 2025

Feedback

For feedback and questions send an email to efspieurope@gmail.com.