| Priority topic | Status | Lead(s) | Download charter |
|---|---|---|---|
| Application of Bayesian methods in drug development | Active | Mike Krams, Nicky Best | X |
| Covariate adjustment | Active | Alex Ocampo | X |
| A framework to appraise statistical methods building on ICH M15 | Completed | Tobias Mielke | X |
| Specific topics related to estimands | To be confirmed | David Wright | X |
| AI | Active | Marc Vandemeulebroecke | X |
Priority topics
Currently, the EFSPI methods leaders are working on five priority topics. These topics are aligned with both EFSPI and EFPIA and input from further stakeholders, e.g. the EFSPI / PSI eSIGs, is sought as well. The idea is to contribute to scientific discussions through publications and presentations and to be prepared for discussions with regulators once there are opportunities, e.g. within EMA multistakeholder workshops.