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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
(Janssen Research & Development)
, Johnson & Johnsonlvanmet@ITS.JNJ.com
Katie Warren (
Nicola Newton, PHUSE Project Assistant
)

katie@phuse.global

nicky@phuse.global


Status
colourBlue
titleCURRENT STATUS
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

Status
colourBlue
titleCURRENT STATUS
Q1 2023

Working on a White Paper

Project MembersOrganisation Ashik Chowdhury Cytel Alexandra CochinaireJohnson & JohnsonArman 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 BruneroPPDIrfan AliTigermedJennifer, BrittGileadJohn ScottFDAJonathan Siegel Bayer Jozef AertsXML4PharmaJunxiang LuoModerna Kevin LiuPfizer Kirti BhattTigermedKim Musgrave AmgenProject MembersOrganisation Lauren ShinaberryAbbvieLiping SunFDALisa LinFDAMarc Walton Janssen Research & Development Marian MitroiuBiogenMatt Baldwin AmgenMindy Mo BayerMunish MehraTigermedNaga DontamsettyTakeda Nikhil SudarshanJazz PharmaceuticalsNilani Liyanage Jansen Research & Development Oliver Wirtz Bayer Rama Empati AstraZenecaRama KalyanammaICONRhian 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 

 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