1 Leads

Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche, both located in Basel, Switzerland. Their email addresses are generic .

2 Task forces and members

After a first phase where five subteams have written several publications (see below) the working group now operates within seven task forces. Objectives and member rosters of these task forces are available here.

3 Activities

Beyond work in the task forces, the aim of the working group is to provide answers to the above questions through a variety of activities. These will include:

  • Collaborating with experts to refine and possibly extend available methods.
  • Publishing reviews of the available methods, case studies, and white papers with recommendations, for statisticians and non-statisticians.
  • Interacting with regulators and the broader clinical community to obtain a better understanding of their requirements. Work with them to agree on common definitions of estimands in oncology.
  • Providing trainings, workshops and talks.
  • Promoting good practice through templates for study protocols and statistical analysis plans.

4 Collaborations

The working group closely collaborates with the EFSPI/EFPIA Estimands Implementation WG (EIWG) to implement estimands in drug development by collaborating with non-statistical partner functions. Stefan Englert is a member of both working groups and leads that collaboration.