The CFAST Approach: Developing TA Standards Efficiently and Collaboratively. Rhonda Facile, BA, MS Vice President, Standards Development

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2 The CFAST Approach: Developing TA Standards Efficiently and Collaboratively Rhonda Facile, BA, MS Vice President, Standards Development 2

3 Agenda CDISC The CFAST Initiative TA Development Process CDISC SHARE FDA Specifications TA User Guide Orientation Year 3 Lessons learned How to get involved CDISC Fellows Program 3

4 Acknowledgements Thanks to Wayne Kubick, Rebecca Kush, Diane Wold and Rachael Zirkle for their contributions to this presentation. 4

CDISC has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical research data and metadata to improve data quality and

5 CDISC has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical research data and metadata to improve data quality and streamline medical and biopharmaceutical product development and research processes Consensus-based development Standards are freely available at IP Policy ensures open standards

6 CDISC CDISC Board of Directors CDISC Coordinating Committees CDISC Advisory Council CDISC Operations CDISC Teams CDISC User Networks Members, Supporters, Volunteers, Stakeholders, Adopters CDISC 2014

7 Disclaimer CDISC Standards specify how to structure the data to support efficient data sharing for regulated clinical trials CDISC Standards Do Not specify what data should be collected or how to conduct clinical trial protocols, assessments or endpoints. 7

8 It s about Patients! CDISC

9 CFAST is an initiative of CDISC and the Critical Path Institute to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health.

TAPSC Identifies Risks and Opportunities

10 Collaborations & Governance CFAST SAC Scientific Advisory Committee CFAST TAPSC Therapeutic Area Program Steering Committee Provides Scientific Advice to TAPSC Identifies Risks and Opportunities Identifies/Engages Relevant Partners Prioritizes/Approves Proposals Approves Projects & Charters Resources & Oversees Projects CDISC

Project Organization & Roles CDISC Standards Review Council CFAST TA Steering Committee (TAPSC) CFAST Scientific Advisory Committee (SAC) SDS Team Project Manager Program Manager CDASH Team TA

11 Project Organization & Roles CDISC Standards Review Council CFAST TA Steering Committee (TAPSC) CFAST Scientific Advisory Committee (SAC) SDS Team Project Manager Program Manager CDASH Team TA Clinical Experts Modeling Expert CDISC Governance ADaM Team TA Statistics Experts Terminology/Q RS Experts CFAST Governance Terminology/Q RS Teams Metadata Developers Technical Writers CDISC Team Representatives Medical Writer Review Community CDISC, C-Path, FDA, PMDA, Transcelerate BioPharma, Inc., Key Opinion Leaders, Medical Associations, U.S. National Institutes of Health, Innovative Medicines Initiative, others Collaboration and Feedback 11

12 CFAST Program Launched in 2012 by partners CDISC and C-Path SAC initiated in 2013 Asthma Pilot completed November 2013 included: Enhanced development process* Introduced new roles* TA User Guide content & layout* Concept modeling using concept maps* Metadata displays* SDTM Goal is to expand content to developing concept level Beginning to End Biomedical Concepts (* new aspects) 12

13 Working Principles Focus on Core concepts that apply to all phases of clinical trials in a specific TA Minimal Valuable Product (MVP) for 1 st versions Minimize text, where possible Focus on explaining concept maps, metadata and examples Use SHARE eco-system tools, where possible As tools become available, use them to develop concept metadata Reuse content to assemble TA packages 13

14 Published Standards Standards Available for Download! 14

15 Program Overview November 2015 Therapeutic Area Project Project Manager Stage 0 Charter Approval Stage 1 Check of Concepts Completed Stage 3a Posted for Internal Review Stage 3b Posted for Public Review Stage 3c Projected Standards Publicatio n Notes Traumatic Brain Injury v1 Amy Palmer Oct 13 Sep 14 Mar Jul Q415 SRC Review for Pub: Nov 2 Breast Cancer v1 John Owen Oct 14 Oct 14 Mar Nov Q116 PR: Nov Upcoming Publications 4Q15/1Q16: Traumatic Brain Injury (Just Published!) Diabetes ADaM Supplement COPD Breast Cancer Diabetic Kidney Disease Tuberculosis v2 COPD v1 Sherwood Barbee Sep 14 Dec 14 Jul Nov Q415 PR: Nov 4 Dec7 ADaM Supp to Diabetes v1 Rachael Zirkle NA NA Mar Jul Q415 SRC Review for Pub: Nov 23 Diabetic Kidney Disease v1 Rachael Zirkle May Aug Nov Jan 16 Q116 Tuberculosis v2 Laura Butte Apr Apr Sep Oct Q116 PR: Oct 28 Nov 30 Rheumatoid Arthritis v1 Trisha Simpson Jun Oct Dec Jan 16 Q216 CV Imaging v1 Amy Palmer May Jul Nov Jan 16 Q216 SRC Review for PR: Nov 23 Prostate Cancer v1 John Owen Nov Q316 MDD v1 Amy Palmer Nov Q316 GAD v1 Amy Palmer Triple- Scope Q316 Bi-polar Disease v1 Amy Palmer Triple- Scope Q316 Solid Organ (Kidney) Transplant Laura Butte Jan 16 Q316 Stage 0 Scoping, Stage 1 Concept Modeling, Stage 2 Standards Development, Stage 3a Internal Review, Stage 3b Public Review, Stage 3c Publication November 3, 2015 Key Stage completed Stage ongoing All months reflect when stage is, or is projected to be, completed.

16 CFAST Pipeline 16

17 CDISC TA Standards Development Process 17

18 CDISC

19 Process for developing content Set scope Enough to be useful Not too much to achieve in months Identify regulatory and clinical guidelines Involve clinicians Start with system-independent concept maps Where does the data come from? What are the data items and what do they mean? How are the data items related? Stage 1 Scoping

20 Process for developing content Stage 2 Concept Modeling Develop biomedical concept metadata Based on the BRIDG model to provide underlying consistency Includes CDASH and SDTM metadata Includes controlled terminology values and subsets of values Develop implementation examples Create TA User Guide Modules CDISC review process Internal cross-team review Public Review Stage 3 Develop Standards Stage 3a Internal Review Stage 3b Public Review

21 Beginning to End Coverage The first CDISC TA standard (TB, 2012) was a supplement to the SDTMIG Organized by SDTM domain No mention of any other standard CFAST TA projects expanded to other standards Asthma: SDTM, prototype biomedical concept metadata Diabetes: added CDASH examples QT Studies: included ADaM examples Schizophrenia: includes trial design examples

22 Growing Content Piloted ADaM supplement coming Q4 TAUG Components Some CDASH under consideration CDASH, ADaM - TBD Terminology SDTM CDASH ADaM 22

23 Adding depth Biomedical concept metadata: a small package of relevant variables and terminology for a particular research concept (e.g., a particular test) CDASH prompt/question text SDTM domain, test/test code Applicable variables Computational method, if applicable (e.g., BMI) Subset of relevant controlled terminology To be curated in SHARE metadata repository

24 CDISC SHARE

25 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

26 SHARE SHARE is CDISC s metadata repository along with supporting tools The first priority for SHARE was loading existing standards CDISC development teams are benefitting from SHARE Consistency checking, version comparisons Cataloging domains, supplemental qualifiers, examples Will be the repository for biomedical concept metadata

27 Biomedical Concept Metadata Concrete, machine readable value level metadata Implementation use cases: Building protocol schedule of events Automating CRF creation Automating database creation Automating tabulation (SDTM) creation Tabulation validation Metadata-driven analysis

28 Impact on implementers Today Extrapolate for data not in implementation guides Connect up separate standards Figure out how to pull together the right structural and terminology elements Future Standards cover more content TA user guides and biomedical concept metadata integrate across standards Download machinereadable, immediately useable standards

29 SHARE Video VdvgVpY8&feature=youtu.be

30 30

31 FDA TA Standards Acceptance Project 31

32 TA Standards Specification for FDA & User Guides Modularized Content Normative TA Specifications For the FDA data standards catalogue Includes: New domains/variables specifications Domain tables New variables» Standard and Non- Standard SDTM Rules Controlled Terminology Known issues Evolve to Biomedical Concept Metadata tables over time Non-Normative TA User Guides For data managers, programmers, others.. Includes: Implementation instructions Concept maps and explanations Examples SDTM, Controlled Terminology and other standards Appendices Glossary Known issues References Team list IP policy

33 FDA TA Standards Acceptance Project Source: draft dyslipidemia Spec

34 FDA TA Standards Acceptance Project Source: draft dyslipidemia spec 34

35 FDA TA Standards Acceptance Project Initial Implementation plan Published TA Standards Dyslipidemia by EOY QT Studies Hepatitis C Virus Diabetes TBv2 Ongoing projects Plan under development BrCa to be ready at the publication of the TA User Guide

36 CDISC s Evolving Culture of Learning 36

37 CDISC s Culture of Learning Assessment & Feedback Lessons Learned Does it work/not work? Make needed changes Group Interaction Use of dialogue & skillful discussion to draw out group intelligence that is greater than the sum of individual member s talent. Coaching Modeling Expert CDISC Experts, SRC, etc. Forums Concept Modeling Metadata Development Best Practices Process documentation Tools, Checklists, etc Leverage Technology CDISC SHARE Technology Best Practices Assessment & Feedback Forums Group Interaction Coaching (Adapted from Peter Senge, The Dance of Change: The Challenges of Sustaining Momentum in Learning Organizations, Doubleday, New York, 1999) 37

38 NEW ROLES TA Clinical Expert Consultative role. A therapeutic area expert who checks accuracy of modeling, via concept maps and CRF modules. *Metadata Developer person who interacts with TA Clinical Expert, draws concept maps, populates concept template for individual concepts, requests new terminology and prepares examples *Metadata Curator person who loads metadata into and extracts metadata from SHARE. Checks new concept templates and maps Modeling Expert Consultative role. Person who creates and/or checks new concept templates. SHARE Programmer person who writes programs to turn concept template diagrams into concept metadata tables. May also create/improve tools ( e.g. CRF generator and SDTM generator). *roles merge over time?

39 Metadata Tools Team Purpose Ensure Metadata Developer training is available and comprehensive Ensure additional resources, (e.g., examples and templates for concept maps, metadata spreadsheets, and SDTM examples) are easily accessible Ensure clearly defined processes are available and accessible Provide support for Concept Mapping Forum and Metadata Development Forum 39

40 Metadata Developers Forum Purpose: To provide a forum for presenting and discussing SDTM modeling issues that arise during TA development. Feedback at the earliest stage of data modeling (reduces rework of examples) Provides modeling support at all levels of review (Internal, SRC, Public) Consistent modeling across TAUGs Areas Covered: TAs: Hep C, Schizophrenia, TBI, TB, Virology, COPD Topics: Challenges of using the physiology domains, deciding when to use FA, terminology issues surrounding PRTRT and SUTRT When: twice weekly 40

41 Concept Modelers Forum Purpose: To teach concept modeling approaches & support development teams Areas Covered: All TA projects, as needed. Foundational team projects are also welcome. Topics: Representing research concepts and their metadata visually, mapping domain models, learning to use the tool When: Meets twice weekly, as needed 41

42 Toolkits for TA and Foundational Teams Foundational Standards 1. Standards Development Guideline 2. Standards Development Process Map 3. Internal Review Checklist 4. Public Review Checklist 5. Publication Checklist TA & Foundational 1. Project Proposal Template 2. Project Charter Template 3. Project Plan Template 4. Lessons Learned Template 5. Communications Process Table 6. Review Stages Summary 7. CDISC Style Guide 8. SRC QC Checklist 9. SRC Transmittal Form 10.Instructions on using the Internal/Public Comment Tracker 11.Comment Resolution Instructions 12.CDASH Tool kit 13.Development of Concepts & Metadata (Training Module) Location: TA Process Documents Common Process Documents Wiki Therapeutic Area Standards 1. Standards Development Guideline 2. Standards Development Process Map 3. Scoping Checklist 4. Pharma Survey Template 5. Concept Listing Spreadsheet 6. Gap Analysis Template 7. Steps for Searching Clinicaltrials.gov 8. Therapeutic Area User Guide Template 9. SHARE RC Metadata Template 10.Concept Modeling recorded training 11.Concept Modeling Checklist 12.Metadata Developer Resources 13.Internal Review Checklist 14.Public Review Checklist 15.Publication Checklist 16. Project Close-out Checklist 42

43 Oncology Development Plan 43

44 TA User Guide - Orientation 44

45 TA User Guide Contents - Example SDTM metadata Introduction A list of patient directed resources on the Indication SDTM domains SDTM Metadata Examples 45

46 TA User Guide Contents Concept Maps Illustrates relationships among concepts and attributes Facilitates understanding (semantic interoperability) among functions involved in standards development Self-Monitoring Blood Glucose (SMBG) example Diagram 2: Self-Monitoring Blood Glucose Glucose measurements typically performed by subjects with diabetes are indicated. The glucose meter device requires a whole blood sample, but the glucose reading may be read as either a whole blood equivalent or a plasma equivalent.

47 TA User Guide Contents - CDASH Annotated CRF example Hypoglycemia

48 Example CDASH (CRF) Metadata Table - Hypoglycemia

49 CDISC SHARE Metadata Example CM and Treatment Naïve Shows BRIDG basis and detailed values

50 Year 3 Lessons Learned 50

Lessons Learned TA standards development will drive/are driving development of most CDISC standards Attention to project scope is essential Point to

51 Lessons Learned TA standards development will drive/are driving development of most CDISC standards Attention to project scope is essential Point to reference material, don t repeat it Smaller, experienced resourced teams Focused clinical input Large review community input at Internal and Public Review 51

52 Where we are going Streamlining & Modularizing TA User Guides focus on Core information Use Pre-populated templates, where possible Produce Normative Specifications for all TA User Guides for FDA Update Published TA User Guides (point versions) to remove draft domains Create an area on the wiki where those draft SDTM domains and other proposed changes can be maintained. Extract examples from older TA User Guides and loading them into SHARE. Continually observe what works & what doesn t 52

53 How to get Involved Join a TA working group Comment on draft standard at the Internal Review and/or Public Review Attend the Interchange Participate in the CDISC Fellow program 53

54 CDISC Fellows Program CDISC Fellows: Actively participate in the development of CDISC standards on a near full-time basis for a fixed period of time (nominally one year) Develop proficiency in the development, use and maintenance of standards Acquire knowledge that can be leveraged internally by sponsoring companies Provide ongoing part-time expertise as a reviewer or other participant to the CDISC collaboration community 54

CDISC Fellows Class of 2015-2016 Mikenlette Avent, UCB Cliff Reinhardt, UCB Dany Guerendo, STATProg Inc. Kapila Patel, InventiveHealth Dr.

55 CDISC Fellows Class of Mikenlette Avent, UCB Cliff Reinhardt, UCB Dany Guerendo, STATProg Inc. Kapila Patel, InventiveHealth Dr. Helen Sile, FDA* Sharon Powell, Independent* Sandeep Savant, InventiveHealth* Junchao Chen, Shanghai University of TCM* Anayansi Van Der Berg, RA eclinical Solutions* Ruiling Peng, Beijing Improve-Quality Technology Ltd. Co. Phillip Ho, Rundo Int Pharmaceutical Research & Development Co. Qingna (Joy) Li, Xiyuan, Hospital, China Academy of Chinese Medical Sciences *not pictured 55

56 Thank you! 56

57 CDISC Beginning to End (quality, speed, provenance) CDASH ecrfs ODM Protocol SDTM Data Capture ODM Analysis ADaM Database CDISC 2014

Boston Area CDISC User Network 20 July Melissa Cook Octagon Research Solutions

Boston Area CDISC User Network 20 July 2011 Melissa Cook Octagon Research Solutions 1 CDISC SHARE Vision Background Content Development Project Plan Where we are today Next Steps Acknowledgements 2 CDISC