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Scope

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 (
Nicola Newton, PHUSE Project Assistant
)

katie@phuse.global.

nicky@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

Status
colourBlue
titleCURRENT STATUS

Q2/3 2022
  • Meeting on a regular basis to gather information for the White Paper
  • Sub-teams have been formed 
Project MembersOrganisation Alexandra CochinaireJohnson & JohnsonAnn M Pennington Pfizer Arman SabbaghiPurdue UniversityArmin SchuelerMerckgroup Banoo Madhanagopal Bayer 

Benoît Sansas

Pierre FabreBess LeroyCDISCBrent Burger Jazz PharmaCedric Davister MerckDan Checketts Jazz PharmaceuticalsDong Xi Gilead Edwin van SteinGSKElena PolverejanJanssen Research & Development Elisa GomezEli Lilly and Company Emilea Norris CDISCFatma ZohraTigermedFederica BruneroPPDHelle LynggaardNovo Nordisk Irfan AliTigermedJennifer, BrittGileadJohn ScottFDAJonathan Siegel Bayer Jozef AertsXML4PharmaJunxiang LuoModerna Kevin LiuPfizer Kirti BhattTigermedKim Musgrave AmgenProject MembersOrganisation Liping SunFDALisa LinFDAMarc Walton Janssen Research & Development Matt Baldwin AmgenMindy Mo BayerMunish MehraTigermedNikhil SudarshanJazz PharmaceuticalsNilani Liyanage Jansen Research & Development Oliver Wirtz Bayer Rama Empati AstraZenecaRhian Jacob- Moffatt RocheRobin WhiteEli Lilly and CompanyRosanne LaneJanssen Research & Development Samson GhebremariamNovartis Santosh K Lingala Gilead Shahida Tamboli Labcorp Stephen Ruberg Analytix ThinkingSteve Gilbert Pfizer Steve WilsonFDASonali AmbureTigermedSudhakar BollineniTigermed Sujitha Susan JohnNovo Nordsik 

Q1 2024

  • Completed public review of White Paper
  • Great interest in paper as received over 400 public comments
  • Collaborating with EIWG statisticians to align white paper recommendations
  • Poster session at the US Connect and presentation at International Society for Biopharmaceutical Statistics (ISBS) 2024




Objectives & DeliverablesTimelines

Submit abstracts for multiple conferences 

Q2 2023

Develop draft White Paper for internal project review prior to PHUSE Working Group Review and Public Review

Q3 2023

 Final White Paper

Q1 2024
Venkat GajjiTigermedVidya Jayapalan TakedaXiaohan ZouBristol Myers SquibbYongming QuEli Lilly and Company Yun Peng Bristol Myers SquibbZongjun Zhang Eli Lilly and Company