TransCelerate BioPharma, Inc. Clinical Data Standards Project. Dave Jordan Data Standards Project Leader

Transcription

1 TransCelerate BioPharma, Inc. Clinical Data Standards Project Dave Jordan Data Standards Project Leader 1

2 Outline TransCelerate Overview CFAST Overview Therapeutic Area Standards Project CDISC SHARE Q & A 2

3 Charter Members of TransCelerate BioPharma Member Representatives John Leonard (Board Member) SVP Chief Scientific Officer Briggs Morrison (Board Member) EVP, Global Medicines Development Paul Stoffels (Board Member) Worldwide Chairman of the Pharma Group Martin Fitchet (Treasurer) SVP Projects, Clinical Platforms & Sciences Jan Lundberg (Board Member) EVP of Science and Technology Klaus Dugi (Board Member) Corporate SVP, Medicines Mikael Dolsten (Board Member) President of Worldwide R&D John Hubbard (Alternate Board Member) SVP Development Operations Brian Daniels (Board Member) SVP Global Development & Medical Affairs Corsee Sanders (Board Member) Global Head of Development Innov. & Clin Ops Patrick Vallance (Board Member) President, Pharmaceuticals R&D Lynn Marks (Alternate Board Member) SVP, Clinical Platforms & Sciences Elias Zerhouni (Board Member) President of Global R&D 3

4 New Members of TransCelerate BioPharma Member Representatives Sef Kurstjens (Board Member) CMO & President Pharma Global Development Alfred Sandrock (Board Member) SVP, Head of Development Sciences& CMO Garry Neal (Board Member) Head of R&D Marco Taglietti (Board Member) President, Forest Research Institiute & CMO Annalisa Jenkins (Board Member) Head of Global Development & Medical Pablo Cagnoni (Board Member) EVP, Global Head of R&D 4

5 The intent is not to re-create, but rather partner with existing collaborations which closely align with project activities Engagement with the Larger Ecosystem Outside organizations, including regulatory, public, government and industry-based entities, are being engaged. Industry Initiatives Health Advocacy TransCelerate BioPharma Inc. Regulatory Bodies Research and CRO Community 5

6 TransCelerate Clinical Data Standards Project Opportunity Description Long Term Vision: Create common Clinical Data Standards (therapeutic area in addition to existing safety domains) and metadata standards for integrating clinical data from disparate sources as a foundation for end-to-end data flow Goals: Dedicate effort and investments to assist [partner with] CDISC, C-Path and FDA to complete CFAST Therapeutic Area [TA] data standards projects more rapidly Roll-out new TA data standards every few months as particular disease areas are completed Also drive adoption to realize benefits and enable interoperability across companies, foundations, health authorities Standards are the key foundation for achieving vision for the semantic interoperability described in recent FDA draft Guidance for providing regulatory submissions in electronic format (standardized study data) ADaM = Analysis Data Model CDASH = Clinical Data Acquisition Standards Harmonization SDTM = Study Data Tabulation Model 6

7 Coalition For Accelerating Standards & Therapies CFAST - an initiative to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health Objective - Identify common standards for representing clinical data for studies of drug products in specific, prioritized therapeutic areas [TA] To be implemented using CDISC structures (CDASH, SDTM) Support integration of clinical data from disparate sources as a foundation for end-to-end data flow 7

8 Therapeutic Area Standards Governance Model CFAST Steering Committee CFAST Scientific Advisory Comm. CDISC Leadership FDA CDISC C-Path TransCelerate BioPharma CFAST Program Manager(s) TA Project Core Teams Project Manager Terminology Lead Clinical Lead BRIDG Modeler Data Standards Lead Data Analyst Statistics Consultant Technical Writer C CFAST Support: IT Admin Communications CDISC Foundational Standards Teams Community and Process 8

9 CFAST TA Data Standards Development 2013 Plan cfast _planv1.pdf 9

10 Diabetes Project Organization CFAST Steering Committee Project Leader CDISC CTO Process Consultants Project Tracking & Reporting Technical Writer Scoping & Input Team Terminology Team Concept Creators Metadata Analysts TA Clinical Experts CDISC CT Team BRIDG Consultant Works with SDS and CDASH liaisons Statistics/Analysis Experts Questionnaire Team Review Communities (CDISC, NCI, Diabetes Medical Associations, NIH, FDA, etc..) 10

11 TA Standards Development Initiative Core principles: 1. Use an open and transparent process 2. Adopt or adapt existing standards [data elements and terminologies], where possible 3. Ensure engagement and input of clinical and medical professional societies, as well as government agencies 4. Utilize a well-defined data standards governance function 5. Scope projects to develop standards incrementally 11

12 Definition of Requirements Documenting efficacy data requirements for individual TAs Primary and secondary outcome measures Key exploratory endpoints (including new biomarkers) Covariates Collect preliminary requirements from identified sources Drug development guidances for the identified TAs Public clinical trial information sources Submission documents (CRFs, clinical study reports, agency reviews) CDISC standards (e.g. SDTM IG) 12

13 Therapeutic Area Standards: Baseline Content Mindmap/model of disease area clinical concepts Essential core data elements with definitions, data types (simple & ISO 21090), BRIDG and SDTM mappings SDTM domains and examples Minimum value sets (code lists) with definitions and c- codes User/Implementation Guide with permissions statement Standard CDASH CRFs with SDTM annotations, as appropriate Ideally, ADaM Analysis model examples Possibly study design models 13

14 Single, trusted, authoritative source for CDISC data standards Concepts, metadata, collections, relationships, value sets across the full spectrum of CDISC content Links research to healthcare concepts to support interoperability Aligned with NCI Semantic Systems BRIDG, ISO21090 b. Gov c workflows a. Change control c. Impact Analysis & Inheritance Protocol, CDASH SDTM, ADaM a b c SHARE Facilitates Data Exchange Access to data standards Source to target mapping & traceability Transformation logic Terminologies Adapted from Source by Sue Dubman, Sanofi-Aventis

15 Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. Margaret Mead Questions? 15