Charter for EFSPI/PSI Special Interest Group (SIG) on Neuroscience biostatistics community

Background
This SIG will have two connected groups:
  • Biostatistics Neuroscience community
  • Working groups on Neuroscience biostats topics, with initial focus on estimands in neuroscience

Goals/Objectives/Scope
Biostatistics Neuroscience community
  • To support/strengthen the role of biostatistics in drug development through contributions to innovative methodology and study designs, leading to optimization of development of new medicine for Neuroscience
  • To identify areas where collaboration between companies and academia is possible and can add substantial value to drug development. 
Working group on estimands
  • Potential overview on how to formulate estimands in different Neuroscience indications
  • Link the estimand question to statistical analyses in general
  • Support development of common definitions for estimands of interest in estimand working groups for individual indications based on precise understanding of the treatment effect relevant in the individual indications
  • Investigate which methods provide valid estimation for the estimand/effect of interest
  • Investigate which methods provide valid estimation specifically for treatment policy estimands
  • Investigate which Sensitivity analyses are possible aligned to different estimands 
  • Out of scope:
  • Specific estimands for AD (separate working group under ASA)
  • Future use of MMRM in AD (separate working group under ASA)
Outcome:
  • White paper and/or publication on estimand proposals for different Neuroscience indications
  • Aim to publish estimands for a variety of different diseases and considering different strategies for intercurrent events
  • If needed potential consultation with HAs to get agreement on future standard method and/or agreement on continued use of current standard methods under certain conditions
  • Where possible, seek perspectives from regulatory and HTA agencies on estimand proposals
Note:
The working group on AD under ASA includes a substream on estimands in AD and possible replacements for MMRM. However it is unlikely that this work will cover all work needed for Neuroscience in general as there are specific differences in AD versus overall Neuroscience. Different types of estimands might be relevant/required for certain Neuroscience diseases, therefore requiring a different Estimand working group to be formed. 

Principles:
Biostatistics Neuroscience community
  • Meets regularly ~4 times a year via TC
  • Arrange f2f meetings at conferences if possible
  • Only few representatives from each company to participate 
  • Transparent to the outside world
  • Open to large and small companies in the pharmaceutical industry and academic institutions
  • Exchange methodological information 
  • Do not exchange confidential molecule/project specific information
  • Can initiate working groups on Neuroscience specific methodological issues together where collaboration is possible and can add substantial value
Working group on estimands
  • Every company and academic institution interested can join and add statisticians to the group
  • Monthly TC to organize work 
  • Important that meeting participants make efforts to contribute to working groups and working groups initiatives and discussions
Organization
  1. Membership click here
  2. Information sharing: Via the EFSPI and PSI websites, EFSPI and PSI Newsletters, webinars, presentations at conferences, publications in mainstream journals.