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Project Scope

The scope of this project is to evaluate and recommend approaches for SEND harmonization 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

Snyder, FDA

kevin.snyder@fda.hhs.gov

Mark Carfagna, Eli Lilly

carfagna_mark_a@lilly.com

Lauren White (
Alex Pearce, PHUSE Project
Coordinator)
Assistant
lauren@phuse

Alexandra@phuse.global

Objectives and DeliverablesTimelinesPrioritised list of domains/variables required for harmonisation

Q3 2020 Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ2 2021Poster presentation and update of current Working Group progress at CSSQ3 2021 PHUSE Publication or White PaperQ1 2022


Status
colourBlue
titleCurrent Status

 Q12021

Q4 2023

  • Re-scoping the project to focus on virtual control data


Resources 
Recommendations for Exchanging Vehicle details using SENDIG v3.1 public review completed – Leads updating following the feedback 

Recommendations for Populating Control Type (TCNTRL)

Using

with CDISC SEND Controlled Terminology

– PHUSE internal review 
  • Team to map clinical observation data to RESCAT categories (clinical observation terminology from multiple sources)
    • ResourcesVehicle Components SurveyDraft White Paper SEND Package ASEND Package BSEND Package CSEND Package D

    Supporting the Use of SEND for the Implementation of Virtual Control Groups



    Objectives & DeliverablesTimelines
    Develop plans for a new, re-scoped project that will focus exclusively on applying harmonisation of SEND data to facilitate implementation of virtual control groups in toxicology studiesQ2 2023
    Continued work on consulting with other consortia to understand the critical data needed for virtual controls definingQ3 2023
    Host a workshop at the PHUSE CSSQ3 2023

    Project Members 

    Organisation Bill HouserBMS

    Cheryl Sloan

    BMS

    Deepa Smant

    Comcast

    Erin Mulrooney

    BioCelerate

    Gen Sato

    Eisai Co.

    Joseph Horvath

    BMS

    Michele Dunleavy

    BiocelerateNicolas PhilippePointCrossPatricia BrundageFDARick ThompsonJanssen Research & DevelopmentSteve PolleyGSKSue DehavenSanofiTodd PageEli LillyWang WenxianXybion