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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

nicky@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 review

Q4 2022

Final paper published

Q1 2023

Status
colourBlue
titleCURRENT STATUS

Project approved

Q1

2022Project MembersOrganisation Ann M Pennington Pfizer Arman SabbaghiPurdue UniversityArmin SchuelerMerckgroup Bess LeroyCDISCCedric Davister MerckDong Xi Gilead Elena PolverejanJanssen Research & Development Jennifer, BrittGileadJohn ScottFDAJonathan Siegel Bayer Junxiang LuoModerna Kevin LiuPfizer Kim Musgrave AmgenLiping SunFDALisa LinFDANilani Liyanage Jansen Research & Development Marc Walton Janssen Research & Development Rama Empati AstraZenecaRobin WhiteEli Lilly and CompanyRosanne LaneJanssen Research & Development Santosh K Lingala Gilead Shahida Tamboli Labcorp Stephen Ruberg Analytix ThinkingSteve Gilbert Pfizer Steve WilsonFDAVidya Jayapalan TakedaXiaohan ZouBristol Myers SquibbYongming QuEli Lilly 

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