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Project Scope

The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data.


Project Leads

Email

Kevin Synder

kevin.snyder@fda.hhs.gov

Mark Carfagna

carfagna_mark_a@lilly.com

Paula Rowley (PHUSE Project Assistant)

paula@phuse.global 



Objectives and DeliverablesTimelines
Prioritised list of domains/variables required for harmonisationQ3 2020 
Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ2 2021
Poster presentation and update of current Working Group progress at CSSQ3 2021 
PHUSE Publication or White PaperQ1 2022


Status
colourBlue
titleCurrent Status
 Q22021 Q3/42021

Control Type White Paper: Addressed public reviewers’ comments and resubmitted for final publication. The scope has been broadened to include all control types.​

Formed working groups to progress the facility/animal supplier name and location, and RESCAT projects. 




Project Members 

Organisation 
Annika KreuchwigBayer
Bill HouserBristol Myers Squibb

Cheryl Sloan

Bristol Myers Squibb

Deepa Smant

Comcast

Gen Sato

Eisai 

Joseph Horvath

Bristol Myers Squibb
Matthew CrawleyBiocelerate

Michele Dunleavy

Biocelerate
Nicolas PhilippePointCross Life Sciences 
Patricia BrundageFDA
Rick ThompsonJanssen Research & Development
Steve PolleyGSK
Sue DehavenSanofi
Todd PageEli Lilly
Wang WenxianBristol Myers Squibb