Neuroscience-Estimands European SIG

Purpose

This SIG will have two connected topics:

  1. General biostatistics Neuroscience community
  2. Working groups on estimands in neuroscience and other topics in neuroscience

 

Publications and slide decks

The group did work on the impact of Covid-19 pandemic on clinical trials in Neuroscience and provides recommendations. This is thought to be a living document with regular updates.

The impact of Covid-19 on clinical trials in NS V1.0 final

 

Objectives

Biostatistics Neuroscience community:

  • To support/strengthen the role o biostatistics in the edvelopment of new medicine for Neuroscience
  • To identify areas where collaboration between companies makes sense

Working group on estimands:

  • Potential overview on how to formulate estimands in different CNS indications
  • Link the estimand question to statistical analyses in general
  • Define situations in which MMRM can still be used even when theoretically addressing a treatment policy estimand
  • Alternative methods to MMRM for treatment policy estimands
  • Sensitivity analyses
  • 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
  • If needed potential consultation with HAs to get agreement on new standard method replacing MMRM and/or agreement on continued use of MMRM under certain conditions

Note:

The working group on AD under ASA includes a substream on estimands in AD and possible replacements for MMRM. This work will however, unlikely cover all work needed for Neuroscience in general, as there are specific differences in AD versus overall Neuroscience.

Certain areas of high unmet medical need and restricted development options like rare diseases in Neuroscience would not be addressed by the AD working group.

 

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 pharmaceutical industry
  • Exchange methodological information
  • Do not exchange molecule/project specific information
  • Can initiate working groups for working on CNS specific methodological issues together where it makes sense to do it together

Working group on estimands

  • Every company interested can join and add statisticians to the group
  • Monthly TC to organise work would seem meaningful

 

Organisation

  1. Membership (see table below)
  2. Information sharing: via the EFSPI and PSI websites, EFSPI and PSI Newsletters, webinars, presentations at conferences, publications in mainstream journals.

Membership

Name Company/Institution
Andrew HartleyPPDI
Akiko OkamotoJ&J
Charlie CaoBiogen
Christopher MillerAsztrazeneca
Christopher CoffeyUniversity of Iowa
William S ClarkLilly
David S KellerPfizer
Fabian ModelHoffmann-La Roche
Georg KralidisIpsen
Ih ChangBiogen
John O'GormanBiogen
Khadija RantellMHRA
Klaus Groes LarsenLundbeck
Hong Liu-SeifertLilly
Markus AbtHoffmann-La Roche
Marisa BacchiJ&J
Mette Krog JosiassenLundbeck
Sofia MosesovaDenali
Nikolaos SfikasNovartis
Peter QuargNovartis
Ulrich FreudensprungBiogen
Veronique RobertServier
Weining (Winnie) RobiesonAbbvie
Hans Ulrich BurgerHoffmann-La Roche

 


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