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1 CDISC End-to-End UK User Group Meeting GSK, Stockley Park 24 th October 2007 Dave Iberson-Hurst CDISC VP Technical Strategy CDISC 2007 Dave Iberson-Hurst CDISC VP Technical Strategy Co-lead Technical Advisory Committee (TAC) Co-Lead Technical Leadership Committee (TLC) European CDISC Coordinating Committee (E3C) Team Lead Co-lead, electronic Source Data Interchange Group (esdi) 2 1

2 Agenda Review of the Models The CDISC Road Map CDISC Operational Road Map Environment 3 Review of the Models 4 2

3 Overview CRO Sponsor Archive Investigator Archive Subject LABs Protocol & BRIDG 5 Operational Data Model CRO Sponsor Archive Investigator Archive Subject Exchange & Archive of clinical data LABs Production Version 1.3 Protocol XML Schema 6 3

4 Original Use Cases Data Interchange Transfer of information between two or more parties than maintains the integrity of the contents of the data. Data Archive Long term storage of files that are no longer in active use 7 Other Use Cases Set up of systems Acquisition ecrf epro EHR esource Trial Registry Submission 8 4

5 Laboratory Data Model CRO Sponsor Archive Exchange of LAB data Production Version Investigator Implementations through SAS, Archive ASCII, XML/ Subject and HL7 V3 RIM message LABs Protocol & BRIDG 9 Use Case Support the bulk transfer of laboratory data 10 5

6 Study Data Tabulation Model CRO Sponsor Archive Submission data (Case Report Investigator Tabulations; analysis data) Production Version 1.1 Referenced as a specification in Archive Subject LABs FDA Guidance - 21 July 2004 Protocol & BRIDG 11 Analysis Dataset Models CRO Sponsor Analysis Data Model Version 2.0, August 2006 Archive Investigator Archive Subject LABs Protocol & BRIDG 12 6

7 Terminology Data Tabulations = SDTM data Analysis Datasets = ADaM data Two sets of data, both are representations of the clinical trial data Each with a specific purpose Source: Susan Kenny, Inspire Pharmaceuticals Inc 13 SDTM & Analysis Datasets SDTM: observations from a clinical trial are particularly useful in medical officer evaluation of safety (with appropriate tools) ANALYSIS DATASETS: restructured and contain additional information (derived variables, flags, comments, etc.) analysis-ready Source: Susan Kenny, Inspire Pharmaceuticals Inc 14 7

8 Protocol Representation CRO Sponsor Archive Investigator Archive HL7-CDISC-NCI Collaboration Objective to develop a standard, structured, machine-readable clinical protocol representation Subject LABs Protocol & BRIDG 15 Protocol Use Case 1. To support CDISC Study Data Tabulation Model (SDTM) -Trial Design -Planned Interventions -Planned Assessments -Inclusion/Exclusion criteria -Statistical Analysis Plan 2. To support study tracking databases, e.g. EudraCT, clinicaltrials.gov, the protocol/trial tracking aspect of trial registry or results databases, or databases that support project management tools (includes SDTM Study Summary) 3. To support the development of the clinical trial protocol document Source: Protocol Team, CDISC 16 8

9 BRIDG CRO Sponsor Archive Investigator Archive Subject LABs Protocol & BRIDG 17 Terminology CRO Sponsor Archive Investigator Archive Covers the work of all teams Subject LABs Protocol & BRIDG 18 9

10 Terminology Collaboration EVS = NCI Enterprise Vocabulary Services RCRIM Source: Andreas Gromen, Schering AG (Bayer) 19 High Level Outline Protocol Set Up Execute Analysis Submission 20 10

11 Conventions SDTM Tabulations = CDISC Standard (content) = CDISC Standard (physical form) used to transport the content using World Wide Web Consortium (W3C) XML Standard 21 Protocol Trial Design Protocol Trial Reg 22 11

12 Protocol Trial Design Protocol Prototype Trial Extension Reg Trial Design 23 Protocol Protocol Prototype Extension Trial Design World Health Organisation (WHO) Trial Registry Trial Reg 24 12

13 Capture CRF Data CDMS LAB Data LAB 25 Interchange CDMS CRF Data Sponsor database 26 13

14 Interchange Sponsor database Sponsor database CRF Data SDTM Tabulations 27 Analysis Sponsor database Sponsor database SDTM Tabulations ADaM Datasets Analysis 28 14

15 Submission SDTM Tabulations SDTM metadata ADaM Datasets SDTM & ADaM data Review database Analysis Reports 29 Submission SDTM Tabulations SDTM metadata ADaM Datasets Analysis Reports Extension SDTM & ADaM data Case Report Tabulation, Data Definition Specification (CRT DDS aka define.xml) Review database 30 15

16 Submission SDTM Tabulations SDTM metadata ADaM Datasets SDTM & ADaM data New Extension Review database Analysis Reports extension to carry SDTM and ADaM data, currently being developed. 31 The CDISC Blueprint 32 16

17 Extensions CRF Data & Metadata Submission Metadata Trial Design Metadata Schema Define.xml extension Schema TDM extension Schema 33 The CDISC Road Map 34 17

18 Role of the Road Map A Road Map any plan or guide to show how something is arranged or can be accomplished Internal to CDISC Provide the overall technical plan External to CDISC Provide users of the CDISC standards with a picture of what is being developed and when it will be developed 35 The CDISC Road Map 36 18

19 The CDISC Road Map Friday 15 th July The CDISC Road Map Purpose: To provide a concise, common specification of all technical products to be developed by CDISC. Endpoint: By 2008, there will be a single CDISC standard for the full lifecycle of a clinical trial or study from protocol representation through the capture of source data to submission and archive, comprising a set of fully integrated and consistent models which will form logically and organically from our current set. Success Criteria: All submissions to the FDA are being made using the CDISC standard; The set of CDISC models in use across the full life-cycle of clinical trials; and The CDISC standard being globally adopted

20 The CDISC Road Map Purpose: To provide a concise, common specification of all technical products to be developed by CDISC. Endpoint: By 2008, there will be a single CDISC standard for the full lifecycle of a clinical trial or study from protocol representation through the capture of source data to submission and archive, comprising a set of fully integrated and consistent models which will form logically and organically from our current set. Success Criteria: All submissions to the FDA are being made using the CDISC standard; The set of CDISC models in use across the full life-cycle of clinical trials; and The CDISC standard being globally adopted. 39 Since the Last Road Map CDISC Strategy has been developed CDISC technical landscape has changed Terminology Glossary Protocol BRIDG CDASH and a lot more CDISC internal processes have improved Technical Advisory Committee (TAC) Technical Leadership Committee (TLC) 40 20

21 So Key Points Road Map is work in progress Emphasis Changed From a single CDISC standard To a harmonized set of CDISC standards Emphasis On CDISC content With multiple supporting transport mechanisms We need to be clear on what we mean by Harmonized Content Transport Work In Progress 41 "Harmonized" that the concepts defined within the standard have agreed and clear definitions; that the relationships between those concepts are agreed; any terminology involved is agreed; and all of the concepts, relationships and terminology are modelled within and consistent with the BRIDG model. Work In Progress 42 21

22 "Content" & "Transport" Content The information we wish to send Transport How we send the information Work In Progress 43 The New End Point The primary end-point of the road map is a set of harmonized CDISC standards for the full life-cycle of a clinical trial from protocol representation through the capture of source data to submission and archive. It is suggested that success should be measured against three criteria: the set of harmonized CDISC standards being globally adopted the set of harmonized CDISC standards in use across the full life-cycle of clinical trials; and all submissions to the FDA are being made using the appropriate CDISC standards; Work In Progress 44 22

23 The New End Point The primary end-point of the road map is a set of harmonized CDISC standards for the full life-cycle of a clinical trial from protocol representation through the capture of source data to submission and archive. It is suggested that success should be measured against three criteria: the set of harmonized CDISC standards being globally adopted the set of harmonized CDISC standards in use across the full life-cycle of clinical trials; and all submissions to the FDA are being made using the appropriate CDISC standards; Work In Progress 45 The New Principles Standards must be aligned (and stay aligned) with the BRIDG model. CDISC must strive towards a harmonized set of standards where: SDTM/SEND, CDASH,, LAB, ADaM, and Protocol define content; Define.xml provides common metadata; the standards share controlled terminology and glossary; platform-independence and platform-neutrality are maintained; and Multiple transport formats for common content are supported. The BRIDG model serves as the portal to healthcare. For a given standard, compatibility with all previous releases of the standard is maintained. Stability for those adopting must be assured. Standards should support all CDISC stakeholders. The standards should be tested within an environment that reflects their operational deployment. Work In Progress 46 23

24 Aligned with BRIDG 47 BRIDG as a Portal to Healthcare Map HL7 RIM Healthcare 48 24

25 Bridging the Silos Map HL7 RIM Healthcare 49 The CDISC Operational Road Map Environment 50 25

26 Tested within an Environment CDISC needs An environment for testing the production standards An environment for evaluating new ideas An environment to demonstrate the standards working This will be provided by CDISC Operational Road Map Environment (CORE) 51 CORE - End-to-End Seminars First exercise undertaken in mid 2005 Informal seminars run 2005 US Interchange 2006 DIA Annual 2006 US Interchange 2007 European Interchange 2007 US Interchange 52 26

27 CORE - CDISC/FDA Pilots First Pilot Submission using SDTM & ADaM Used protocol and data supplied by Eli Lilly Second Pilot Safety submission Pilot CRF Data as part of a submission 53 CORE - Principles CORE is a test-bed, a permanent infrastructure utilizing the web It is CDISC s testing ground It is CDISC s shop window; it demonstrates to the world what CDISC can do It is not a pilot It develops nothing; it takes CDISC product and uses it and reports back 54 27

28 A Familiar Environment HDMI High Definition Multimedia Interface SCART Syndicat des Constructeurs d'appareils Radiorécepteurs et Téléviseurs S-Video Separate Video S-Video HDMI SCART HDMI Phono 55 A Familiar Environment S-Video HDMI SCART HDMI Phono 56 28

29 The Clinical Trials Environment Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review Company Specific The CT Environment - The CDISC Way Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review Protocol CDASH SDTM & ADaM LAB XML 29

30 CORE - The Beginning Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review 59 CORE - Removing the Silos Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review Protocol Setup, Capture & Mapping SDTM Domains SDTM/ADaM Analysis 60 30

31 CORE - Next Steps Develop a detailed plan Based around use cases Working in cooperation with vendors Leveraging the work from the CDISC/FDA Pilots the work from the end-to-end seminars Next milestone being the CDISC Interchange in Copenhagen, April 21-25, Summary 62 31

32 The CDISC Blueprint 63 CORE - Use Cases Work In Progress Protocol Tool 25 3 Study Design Tool National Trial Registry LAB Environment 4 International Trial Registry ,24 Subject Recruitment Tool(s) Protocol Document 1 Data Capture Tool(s) CDMS 9 Analysis Tool(s) 5 Trial Supply Management Tool CDMS 12, 26 20, CTMS 15 Archive System or Warehouse Analysis Tool(s) 13 Review Tool(s) 64 32

33 CORE - The Beginning Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review medidata 65 Summary Road Map will speak to the harmonized set of CDISC standards Focused around content and transport To remove silos Build and end-to-end solution BRIDG playing a central role CORE providing tangible evidence 66 33