Project Scope 

Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:

  • Data Collect Design/CDASH
  • SDTM
  • ADaM (including handling of intercurrent events, missing data imputation) – Analysis Displays
  • cSDRG and ADRG

Development of new standards is not in scope, and any impact findings that may necessitate new standard development will be shared with CDISC for their consideration. Examples may be created on how to implement the framework by using permitted extensions to the existing data standards.

Project LeadsEmail
Chris Price (Roche) 

chris.price.cp1@roche.com

Lori VanMeter (Johnson & Johnson)lvanmet@ITS.JNJ.com
Katie Warren (PHUSE Project Assistant)

katie@phuse.global

Objectives & DeliverablesTimelines

Review current company practices 

Q1 2022

Develop conference abstract 

Q2 2022

Draft paper

Q3 2022 

Conference slides 

Q4 2022

Final White Paper ready for Public Review

Q4 2022

Publish White Paper 

Q1 2023

CURRENT STATUSQ3/4 2022

  • Meeting on a regular basis to gather information for the White Paper
  • Sub-teams have been formed 
  • Initiate drafting of white paper based on finalisation of discussions in both collection and analysis sub-teams  
  • Review of proposals by CDISC 
Project MembersOrganisation 
Ashik Chowdhury Cytel 
Alexandra CochinaireJohnson & Johnson
Ann M Pennington Pfizer 
Arman SabbaghiPurdue University
Armin SchuelerMerckgroup 
Banoo Madhanagopal Bayer 

Benoît Sansas

Pierre Fabre
Bess LeroyCDISC
Brent Burger Jazz Pharma
Cedric Davister Merck
Dan Checketts Jazz Pharmaceuticals
Dong Xi Gilead 
Edwin van SteinGSK
Elena PolverejanJanssen Research & Development 
Elisa GomezEli Lilly and Company 
Emilea Norris CDISC
Fatma ZohraTigermed
Federica BruneroPPD
Helle LynggaardNovo Nordisk 
Irfan AliTigermed
Jennifer, BrittGilead
John ScottFDA
Jonathan Siegel Bayer 
Jozef AertsXML4Pharma
Junxiang LuoModerna 
Kevin LiuPfizer 
Kirti BhattTigermed
Kim Musgrave Amgen
Project MembersOrganisation 
Lauren ShinaberryAbbvie
Liping SunFDA
Lisa LinFDA
Marc Walton Janssen Research & Development 
Matt Baldwin Amgen
Mindy Mo Bayer
Munish MehraTigermed
Naga DontamsettyTakeda 
Nikhil SudarshanJazz Pharmaceuticals
Nilani Liyanage Jansen Research & Development 
Oliver Wirtz Bayer 
Rama Empati AstraZeneca
Randi Mcfarland Ephicacy
Rhian Jacob- Moffatt Roche
Robin WhiteEli Lilly and Company
Rosanne LaneJanssen Research & Development 
Samson GhebremariamNovartis 
Santosh K Lingala Gilead 
Shahida Tamboli Labcorp 
Stephen Ruberg Analytix Thinking
Steve Gilbert Pfizer 
Steve WilsonFDA
Sonali AmbureTigermed
Sudhakar BollineniTigermed 

Sujitha Susan John

Novo Nordsik 
Venkat GajjiTigermed
Vidya Jayapalan Takeda
Xiaohan ZouBristol Myers Squibb
Yongming QuEli Lilly and Company 
Yun Peng Bristol Myers Squibb
Zongjun Zhang Eli Lilly and Company 
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