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Scope 

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.



Q12021

Status
colourBlue
titleCurrent Status

Q3/4 2022

This project

kicked off in March and is working through the OCE/OOD standard safety data request. The first round has completed and the FDA are currently reviewing. The team will take a short break whilst the review is underway and then reconvene for Phase II.

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

Paula Rowleypaula@phuse

Katie Warren

(PHUSE Project Assistant)

katie@phuse.global
 








DeliverablesTimelines
Feedback on publicly available OCE/OOD safety data request.
Q22021
Q2 2021
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).
Q22021Project MembersOrganisationBhupendra MistryRocheCathy BezekAstellasCindy MarabottiSanofiDiane WoldCDISCGopi VegesnaAstellasGreg Ball MerckGregory PurnsleyPfizerHitesh ThackerCovanceHong QiMerckJoy GeMerckKaren YingGSKKen MaahsJanssen Research & DevelopmentKim MusgraveAmgenLihui Deng BMS Lindsay McLeanPHASTARMarleen NijsJanssen Research & DevelopmentProject MembersOrganisationMatt SmithPfizer

Maxime Rouch 

SanofiPaul FrostGEM ProgrammingPavan KumarGSKPeter Bonata BayerBayerSasabindu TripathyTakedaSrinivas KolamuriNovartisSuriaya WalshAstraZenecaSuwen LiRoche

Tatiana Sotingco

Janssen Research & DevelopmentTim YoungGSKVenkata Rajesh DatlaGenmabVishnu DabbiruGSKWenyun JiAbbVieWhitney BoeckelGSKWilliam PaloAbbVie
Q2 2021