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Project Scope 

The goals of this project is to obtain broad industry and CRO feedback on the current publicly available OCE/OOD standard safety data request (found at: https://www.fda.gov/media/133252/download) and assist with the development of resources to assist Sponsors with implementation of these data specifications.

There is tremendous variability and inconsistency in the use of the CDISC ADaM data standard in safety datasets for oncology NDA/BLA applications submitted to FDA. This variability leads to inefficiency in review for the FDA and multiple information requests to applicants during the course of the review to resolve inconsistencies in analyses between FDA and applicants. The Oncology Centre of Excellence (OCE)/Office of Oncologic Diseases (OOD) has developed a pilot standard safety data request for datasets submitted with NDA/BLA applications and instructions for conducting select safety analyses to create a common set of data elements with common use of these variables for safety analyses. The Stakeholders include FDA reviewers and analysts, industry, CROs, and software developers.



  • Gained feedback on the OCE/OOD Standard Safety Request v1.3 using Hoylu, an interactive board for collecting comments from participants at the PHUSE CSS 2021. 
  • Consolidated feedback on the use of the dataset specifications at the PHUSE CSS 2021

    Status
    colourBlue
    titleCurrent Status
    Q3/42021

    Q1 2022

    • This project is currently on hold, the team will reach out for volunteers for the kick off of phase 2



    Project LeadsEmail
    Abhilasha Nairabhilasha.nair@fda.hhs.gov
    Chris Pricechris.price@phuse.global 
    Peter Schotland

    peter.schotland@fda.hhs.gov

    Katie Warren

    (PHUSE Project Assistant)

    katie@phuse.global


    DeliverablesTimelines
    Feedback on publicly available OCE/OOD safety data request.Q22021
    Development of basic resources for sponsors to assist implementation (e.g. CRF design to collect relevant data and linkages for adverse events and dataset preparation for laboratory analyses or other resources requested or found to be needed during the feedback process).Q22021



    Project MembersOrganisation
    Abhinav SrivastvaExelixis
    Bhupendra MistryRoche
    Bohdan WolosiukPfizer 
    Cathy BezekAstellas
    Cindy MarabottiSanofi
    Diane WoldCDISC
    Gopi VegesnaAstellas
    Greg Ball Merck
    Gregory PurnsleyPfizer
    Hitesh ThackerLabcorp
    Hong QiMerck
    Joy GeMerck
    Karen YingGSK
    Ken MaahsJanssen Research & Development
    Kim MusgraveAmgen
    Lihui Deng Bristol Myers Squibb
    Lindsay McLeanPHASTAR
    Marleen NijsJanssen Research & Development



    Project MembersOrganisation
    Matt SmithPfizer

    Maxime Rouch 

    Sanofi
    Paul FrostGEM Programming
    Pavan KumarGSK
    Peter Bonata BayerBayer
    Sasabindu TripathyTakeda
    Srinivas KolamuriNovartis
    Suriaya WalshAstraZeneca
    Suwen LiRoche

    Tatiana Sotingco

    Janssen Research & Development
    Tim YoungGSK
    Venkata Rajesh DatlaGenmab
    Vishnu DabbiruGSK
    Wenyun JiAbbVie
    Whitney BoeckelGSK
    William PaloAbbVie