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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 (FDA)

kevin.snyder@fda.hhs.gov

Mark Carfagna (Eli Lilly)

carfagna_mark_a@lilly.com

Katie Warren (PHUSE Project Assistant)

katie@phuse.global



Objectives & DeliverablesTimelines
Prioritised list of domains/variables required for harmonisationQ3 2020 Q32020 
Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ2 2021Q22021
Poster presentation and update of current Working Group progress at CSSQ3 2021 Q32021 
PHUSE Publication or of White PaperQ2 2022Q22022


Status
colourBlue
titleCurrent Status
Q12022

Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology White Paper sent out for public review​




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