cdisc send update - 2016 · highest being usage of outsourced conversion services or development of...

© CDISC 2016

Presented by Lou Ann Kramer,CDISC / SEND Team Lead

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CDISC SEND Update - 2016

© CDISC 2016

Agenda• Current SEND Development Roadmap• Questions generated by implementation experience• 2016 Workstreams*• SEND team collaborations• PhUSE survey on industry implementation progress• New errata posting process

* A SEND Workstream is a work effort with a defined start and end (vs. a SEND subteamthat manages long-term subject areas)

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© CDISC 2016

SEND Standard Development RoadmapNow (SEND IG V3.0)• CDISC Foundational Standard • FDA Accepts in mid-2011, requires starting

December 17, 20161

• Single and Repeat Dose General Toxicology studies

• Carcinogenicity studies

2016SEND IG 3.1

Safety Pharm Cardiovascular and RespiratoryUpdated domain: Microscopic ObservationsImprovements to representation of timingCorrections and clarifications

SEND IG - DART (Developmental and Reproductive Toxicology) v1.0

SEND for Embryo-Fetal Development studies

FutureDevelopment resources in place• Ocular

• Dermal

• Genetic Tox

• Safety Pharm: CNS

• DART: Multi-generational and fertility studies

Work yet to be defined and prioritized (no resources in place)• Biomarkers?

• Pharmacokinetic studies?

• Pharmacology?

1 For NDAs, ANDAs, and certain BLAs. See section II.A of the Providing Regulatory Submissions In Electronic Format —Standardized Study Data guidance document Also : http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

© CDISC 2016

Standardized data is creating great opportunity for us all, but…

• How do you decide what data types to submit for a study type?

• When would you submit data that is not modeled yet in SEND? Is there value in mapping Antibody-Drug Conjugate (ADC) now?

• How do we know what regulators can use? (Fit for Use/Purpose)

• How can we minimize complexity if different regulatory authorities define requirements differently?

• Is the pace of standards development too fast? What are the most important activities for CDISC SEND now (near/after the mandate)?

• Is different governance needed now to control changes across multiple standards? the rolling nature of standards? the creation of supplements, user guides, or examples?

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© CDISC 2016

2016 SEND Workstreams*Workstreams initiated:1. SEND Model Limits – describe which data is modeled, which is not2. Fit for Use Workstream – better understand useability of SEND V3.0

Workstreams to be prioritized:1. Protocol Amendments – certain amendment scenarios2. Multiple Codelist – when multiple CT codelists apply to one variable3. ORRES – content and usage issues with ORRES and ORRESU4. Domain Improvements for EX, CL, PP, PC, Post-mortem domains5. SEND Conformance Rules – define minimum conformance to the

standard, difference from FDA rules6. IG Versioning – define processes to manage new versions of IGs

and effectively adding or changing domains.

*

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© CDISC 2016

Call for participation yielded good response ( )Watch the public wiki for future updates. (Read the charter there )

Fit for Use Workstream

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• Increase SEND test submissions to CDER by August, 2016• Provide additional feedback to participating submitters (beyond validator reports)• Provide SEND V3.0 usability information to public

http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home

© CDISC 2016

CDISC / SEND team collaboration

• CJUG-SEND team• FDA • PhUSE (nonclinical working group)• IQ Consortium

• Workshop led by Drusafe (noncling IQ), in collaboration with CDISC and PhUSE. Sponsored by American College of Toxicology (ACT)

• Society of Quality Assurance (SQA) / SEND Subteam• Survey

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© CDISC 2016

PhUSE/SQA Survey on Industry SEND Implementation Progress

Full survey and all results are available at:http://www.phusewiki.org/wiki/index.php?title=Industry_SEND_Progress_Survey

• Stage: 55% are implementing a solution, 32% have not started

• Systems: Most companies are using commercially available systems/products, with next highest being usage of outsourced conversion services or development of an in-house system

• Internal Usage: 10% will use SEND datasets toward SD interpretation of study

• QC: 46% will QC to Study reports, 28% to LIMS

• QA: 26% said SEND files will not be reviewed by QA

• Demographics: ~ 50% respondents were sponsor companies, 33% CRO, 6% SEND service providers, 11% other

• We have varied states of implementation and varied approaches

• Questions remain about internal use of SEND datasets and required oversight

• The PhUSE survey team has started meeting to deliver the next annual survey

© CDISC 2016

New Errata page (in development now)

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http://wiki.cdisc.org/display/PUB/Errata

© CDISC 2016

PhUSE Nonclinical Working Group• Focus is SEND Implementation (vs. standards development)• Deliverables include: White Papers, Posters, Input to CDISC SEND Team

2015 Projects continuing into 2016:1. Nonclinical SDRG2. SEND Implementation User Group (and wiki)

(http://www.phusewiki.org/wiki/index.php?title=SEND_Implementation_Wiki)3. Application of SEND Data for Analysis4. Investigating Endpoint Modeling – Biomarkers, ADA data and Immunophenotyping5. Visualization of Group-Related Differences in Histopathology Data6. Industry SEND Progress Survey

New 2016 Projects approved: 1. Test Submission Forum Group2. Nonclinical Script Assessment Project3. Data Consistency: SEND Datasets and the Study Report

For project details: http://www.phusewiki.org/wiki/index.php?title=Non-Clinical_Road-map_and_Impacts_on_Implementation

© CDISC 2016

US FDA Status

• SEND Currently Requested by US FDA CDER§ US FDA Center for Drug Evaluation and Research (CDER)

is receiving SEND submissions now

• Food and Drug Administration Safety and Innovation Act (FDASIA) signed July 9, 2012

• New Guidance Issued 17 December 2014§ Guidance – Submissions Under Section 745A(a) of the

FD&C Act§ eStudy Data Guidance § Study Data Technical Conformance Guide

• FDA Study Data Standards page:http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

cdisc send update - 2016 · highest being usage of outsourced conversion services or development of...

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