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Why use CDISC for trials not submitted to regulators?
Lessons from the experience of an academic clinical trial unit Karl Wallendszus, Will Stevens, Martin Landray International Clinical Trials Methodology Conference, Liverpool 9 May 2017
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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Clinical Data Interchange Standards Consortium
The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
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CDISC standards
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Without standards Dataset names Variable names Codelists
Study #1 – demog.xpt Study #2 – dmg.xpt Study #3 – dm.xpt Study #4 – axd222.xpt SUBJID SEX 0001 M 0002 F 0003 0004 0005 ID GENDER A1 Male A2 A3 Female A4 A5 PT_ID GENDER 0001 1 0002 0003 2 0004 0005 USUBJID SEX 00011 00012 1 00013 00014 00015 Codelists
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With standards Study #1 – DM.xpt Study #2 – DM.xpt Study #3 – DM.xpt
USUBJID SEX ABC-001 M ABC-002 F ABC-003 ABC-004 ABC-005 USUBJID SEX DEF-001 M ABC-001 DEF-002 F DEF-003 DEF-004 USUBJID SEX GHI-001 M GHI-002 GHI-003 F GHI-004 GHI-005 USUBJID SEX JKL-011 F JKL-012 M JKL-013 JKL-014 JKL-015
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Increasing adoption in industry
2016: Mandatory for new studies submitted to FDA, PMDA SDTM ADaM Source: CDISC. The Case for CDISC Standards. 2014
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Adoption in academic trials
Tufts/CDISC Survey on standards adoption (2014) 47/556 (8%) respondents were academic institutions Numbers too small to analyse No mention of CDISC at ICTMC 2015 Source: Lamberti MJ et al. Therapeutic Innovation & Regulatory Science 2015, 49(6)
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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A first attempt Analysis database Study database Raw tables SDTM
Derived tables Datasets Analysis Discrepancies Publications CSR Submission Data sharing N=9438
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A better model Analysis database Study database Raw tables SDTM ADaM
Listings Datasets N=25673 Submission Data sharing Publications CSR N=30449 N=15480
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Legacy studies Analysis database Study database Raw tables SDTM ADaM
Derived tables Datasets New analyses Original analysis N=20536 N=12064 Publications CSR Submission Data sharing New publications
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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CDISC vs organisational standards
CDISC have done the hard work Input from pharma, regulators, academia Coherent Comprehensive Probably better than any one organisation’s standards
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Pinnacle 21 Validator Report
Analysis & validation tools Pinnacle 21 Validator Report Configuration: C:\Users\karlw\Pinnacle 21 Community\components\config\SDTM (FDA).xml Define.xml: C:\Users\karlw\Pinnacle 21 Community Generated: T18:18:54 CDISC CT Version: UNII Version: NDF-RT Version: Software Version: 2.1.2 Processed Sources Domain Label Class Source Records Rejects Errors Warnings Notices GLOBAL Global Metadata -- 4 DM Demographics SPECIAL PURPOSE DM.xpt 2029 6094 891 FA Findings About Events or Interventions FINDINGS FA.xpt 2032 2054 LB Laboratory Test Results LB.xpt 32667 32676 2704 MH Medical History EVENTS MH.xpt 32464 34498 35083 PE Physical Examination PE.xpt 2047 SC Subject Characteristics SC.xpt 8116 8119 28461 SU Substance Use INTERVENTIONS SU.xpt 4058 1126 TA Trial Arms TRIAL DESIGN TA.xpt 16 26 TE Trial Elements TE.xpt 7 TI Trial Inclusion/Exclusion Criteria TI.xpt 21 6 TS Trial Summary TS.xpt 1 TV Trial Visits TV.xpt 19 8 VS Vital Signs VS.xpt 10145 10148 14224 Total 93626 95624 86657 Unprocessed Sources Reason Grand Total
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Documentation: define.xml
Quicker and easier to answer queries
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Metadata Useful common format Long term data storage
Metadata repository Data sharing
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Large user community www.cdisc.org CDISC user networks PhUSE
SAS User Groups
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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Costs Staff training Data managers Programmers Statisticians
Clinicians Mapping non-CDISC to CDISC data Reduced if using CDISC from the start But this also incurs extra cost
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Why use CDISC for trials not submitted to regulators?
Introduction Experience Benefits Costs Discussion
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Discussion Investment up front Benefits seen later
Re-use: subsequent studies quicker Maximum benefit when using standards from the start
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Standards from the start
Protocol, CTR CDASH eCRFs ODM SDTM Data Capture Analysis ADaM Database © CDISC 2014
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Further information Poster 28: Producing CDISC compliant data and metadata for regulatory submissions Karl Wallendszus
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