CDISC/TransCelerate Collaboration and TransCelerate work streams. -Clinical Data Standards -Common Protocol Template -esource

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1 CDISC/TransCelerate Collaboration and TransCelerate work streams -Clinical Data Standards -Common Protocol Template -esource July 2016

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12 TransCelerate Clinical Data Standards Project Opportunity Description Long Term Vision: Support the creation of common Clinical Data Standards (therapeutic area specific data in addition to existing foundational 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, NCI-EVS 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 facilitate 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 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 CDISC

13 Initiative Overview What Is Clinical Data Standards (CDS)? Collaborate with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI-EVS (National Cancer Institute Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies) initiative to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, improving efficiency and scientific knowledge. What Is The Vision? What s the Approach? Develop industry-wide standards that will allow for increased efficiency in research and development. Work in partnership with CDISC, FDA, NCI-EVS and C-Path. Utilize an open and transparent process with a well-defined standards governance function. For Internal Use Only 2014 TransCelerate BioPharma, Inc. Ensure engagement and input of clinical and medical professional societies, as well as government agencies. 13

14 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, ADaM) Support integration of clinical data from disparate sources as a foundation for end-to-end data flow 14 Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 14

15 Therapeutic Area Standards Governance CFAST SAC Scientific Advisory Committee Provides Scientific Advice to TAPSC Identifies Risks and Opportunities Identifies/Engages Relevant Partners CFAST TAPSC Therapeutic Area Program Steering Committee Prioritizes/Approves Proposals Approves Projects & Charters Resources & Oversees Projects Ongoing Maintenance & Enhancement of Foundational CDISC Standards CDISC TA Standards Project Teams Project Leader + Clinical leads (SMEs), BRIDG Modeler, Concept Creators, Terminologists, Metadata Analysts, Stats Consultants, Writers, Communications Research Community Research Community Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 15

16 Project Organization CDISC Standards Review Council CDISC VP, Standards, Terminology and Technical Services Barrie Nelson CFAST (TAPSC) Therapeutic Standards Steering Committee CFAST (SAC) Scientific Advisory Committee CDASH Team Project Manager Program Manager Rhonda Facile SDS Team TA Clinical Experts Process Expert Questionnaires Team ADaM Team Terminology Teams Other CDISC Teams Collaborat es Metadata Developers Statistical Analysis Experts CDISC Team Liaisons Medical Writer SDTM Expert Terminology Expert BRIDG Expert Technical Writer CFAST Governance CDISC Teams Program Resource Project Resource Review Community: CDISC, C-Path, FDA, Transcelerate, Key Opinion Leaders, Medical Associations, U.S. National Institutes of Health, PMDA, EMA, Innovative Medicines Initiative. CDISC Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 16

17 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 1 7 CDISC

18 Vision and 2016 Objectives Clinical Data Standards Vision Develop industry-wide therapeutic area data standards that will allow for increased efficiency in research and development Support CFAST efforts to Publish 8 or more Therapeutic Area (TA) User Guides Leverage Prostate Cancer project to advance next level of SHARE capabilities and synergies within TA development in oncology Facilitate member company adoption of CDISC data standards Collaborate with CPT workstream to support addition of 4-6 new TA libraries Support CDISC to implement SHARE API and RDF Export Share information & Harmonize processes Enables operational efficiencies in data management and analysis, facilitates demonstrating traceability of data and increases efficiency in conducting trials. Enables interoperability across companies, foundations, health authorities Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 18

19 Vision and 2016 Objectives Common Protocol Template (CPT) Vision Develop a model clinical trial protocol, including format and core content, to ease interpretation and enable down-stream automation of many clinical processes. Enable automated disclosure for trial registration Complete proof of concept on the ability to automate ecrf production; if successful run a simulation to quantify the benefit and develop plan to scale up Issue at least one public template update and add 4-6 new TA libraries Share information & Harmonize processes CPT enables protocol information to be presented in the same place, meaning the same thing, across multiple sponsors and protocols. The ability to export key protocol terms from the Technology Enabled Edition of the CPT facilitates sharing of information and harmonizing content across study documents. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 19

20 esource Vision and 2016 Objectives Vision Moving the industry to optimize the use of electronic data sources to improve global clinical science and global clinical trial execution for patients, sites and sponsors. Develop Landscape Assessment (current state, gaps, obstacles) Develop Framework to enable uptake of esource and define esource alternatives(use Cases, Core Principles, Common Terminology, Roles/Responsibilities) Develop Metrics/KPIs Data Collection: study level implementation for demonstration projects Develop Stakeholder Strategy (Health Authorities, Vendors & Vendor Associations, Sites/Patients) Provides unified voice of TransCelerate to Health Authorities to overcome perceived concerns, move faster to steady state, opportunity to influence and shape the environment Enhance Sponsor Efficiencies Supports efficiencies in reducing data transcription, providing traceable end to end data flow Facilitates improves data availability (provides real time data /metadata availability) Provides sponsors with proof of concept to demonstrate viability of using esource tools for regulated trials (e.g. wearables) Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 20

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