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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

Kick off

Q1 2022

Review current company practices 

Q1 2022

Develop conference abstract 

Q2 2022

Draft paper

Q3 2022 

Conference slides 

Q4 2022

Final paper for public reviewWhite Paper ready for Public Review

Q4 2022

Final paper publishedPublish White Paper 

Q1 2023


Status
colourBlue
titleCURRENT STATUS

Project approved Q1 2022

Q2/3 2022

  • Meeting on a regular basis to gather information for the White Paper
  • Sub-teams have been formed 


Project MembersOrganisation 
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
Helle LynggaardNovo Nordisk 
Jennifer, BrittGilead
John ScottFDA
Jonathan Siegel Bayer 
Jozef AertsXML4Pharma
Junxiang LuoModerna 
Kevin LiuPfizer 
Kim Musgrave Amgen



Project MembersOrganisation 
Liping SunFDA
Lisa LinFDA
Marc Walton Janssen Research & Development 
Matt Baldwin Amgen
Mindy Mo Bayer
Munish MehraTigermed
Nikhil SudarshanJazz Pharmaceuticals
Nilani Liyanage Jansen Research & Development Marc Walton 
Janssen Research & Development Oliver Wirtz Bayer 
Rama Empati AstraZeneca
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

Sujitha Susan John

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