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On the Trail of the Holy Grail of SDTM Implementation Three Unique Case Studies

On the Trail of the Holy Grail of SDTM Implementation Three Unique Case Studies. Ken Stoltzfus Clinical Data Strategies Octagon Research Solutions PhUSE 2011.

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On the Trail of the Holy Grail of SDTM Implementation Three Unique Case Studies

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  1. On the Trail of the Holy Grail of SDTM Implementation Three Unique Case Studies Ken Stoltzfus Clinical Data Strategies Octagon Research Solutions PhUSE 2011 © 2011 Octagon Research Solutions, Inc. All Rights Reserved. The contents of this document are confidential and proprietary to Octagon Research Solutions, Inc.

  2. About Octagon • Octagon Research Solutions • A development partnering organization that offers regulatory, clinical, process and IT solutions to the life sciences industry. • Octagon experience on topic: • 600 studies converted to SDTM & ADaM (10,000+ domains) in support of over 54 regulatory submissions to the FDA • CDISC SDTM Co-authors • CDISC SDS Team Lead • Current CDISC team membership: SDS, ADaM, CDASH, SEND, SHARE, and Controlled Terminology • CDISC-authorized SDTMtrainers

  3. Agenda • Standards Governance • Case Studies Company Alpha: Signs and Symptoms Company Beta: Cardiovascular Medical History Company Gamma: Protocol-Restricted Medications

  4. Standards Governance What exactly is standards governance? Oversight Decision-making Development Maintenance Compliance © 2010 Octagon Research Solutions, Inc. All Rights Reserved.

  5. Standards Governance Standards • People Leadership Content decision-makers Developers Data stewards Internal standards CDISC standards Interpretation • Processes Development Business Guidelines Maintenance SOPs • Technical Solutions MDR Request system CDR

  6. Case Studies Ladies and gentlemen: The case studies you are about to see are true. Only the names have been changed to protect the innocent. Any resemblance to real CRFs, whether ongoing or legacy, is purely coincidental.

  7. Case Study 1 – Company Alpha

  8. ALPHA Background • Responding to questions from FDA reviewer • Data mining difficult across unstandardized databases Company Snapshot of the Starting Point Standards Governance • None, although mandate issued to implement CDASH and SDTM • No accompanying authorization for standards governance • Standards development performed by focused group of SAS programmers, Biostatisticians, and EDC builders

  9. STUDYID USUBJID VISITNUM CECAT = ALPHA CESTDTC Date of Assessment Date of Application Time of Application Company Application Site Severity Diameter Rash Post-application 16 hr Post-application 24 hr Post-application 8 hr mm mm mm None Mild Moderate Severe Unknown The eCRF Proposal 1: CE 0006 0010 Subject: Visit Centre: Study: CA-027 Signs and Symptoms SUPPCE QNAM = SSAPPDAT SSAPPTM CELOC RASHDM CESEV CETERM = RASHDMU CETPT CEPRESP = Y CEOCCUR = N CESEV is null CEOCCUR = Y CEOCCUR = U CESEV is null

  10. STUDYID USUBJID VISITNUM X1CAT = ALPHA X1DTC Date of Assessment Date of Application Time of Application Company Application Site Severity Diameter Rash Post-application 16 hr Post-application 24 hr Post-application 8 hr mm mm mm None Mild Moderate Severe Unknown The eCRF Proposal 2: X1 0006 0010 Subject: Visit Centre: Study: CA-027 Signs and Symptoms SUPPX1 QNAM = SSAPPDAT SSAPPTM X1LOC X1TEST = Severity X1ORRES = <value> X1TEST = Diameter X1ORRES = <value> X1TPT X1ORRESU X1TEST = Occurrence of Rash X1ORRES = N X1ORRES = Y X1ORRES = U

  11. STUDYID USUBJID VISITNUM FACAT = ALPHA FADTC Date of Assessment Date of Application Time of Application Company Application Site Severity Diameter Rash Post-application 16 hr Post-application 24 hr Post-application 8 hr mm mm mm None Mild Moderate Severe Unknown The eCRF Proposal 3: FA 0006 0010 Subject: Visit Centre: Study: CA-027 Signs and Symptoms SUPPFA QNAM = SSAPPDAT SSAPPTM FALOC FATEST = Severity FAORRES = <value> FATEST = Diameter FAORRES = <value> FAOBJ = FATPT FAORRESU FATEST = Occurrence FAORRES = N FAORRES = Y FAORRES = U

  12. The Discussion & The Decision ALPHA Company © 2010 Octagon Research Solutions, Inc. All Rights Reserved.

  13. Case Study 2 – Company Beta

  14. B Company Background • Budget crisis • Smarter use of resources • Quicker study start-up • CDISC standards eta Snapshot of the Starting Point Standards Governance • Small DM group managing company’s collection standards • Several internal resources with SDTM expertise from DM and SAS programming performed original SDTM mappings • Eventual highly-visible, strong mandate from senior VP

  15. STUDYID USUBJID VISITNUM MHCAT = B Company MHDTC Date Medical History Taken eta Date of most recent MI Number of MI Yes Yes Yes Yes Yes Unknown Unknown Unknown Unknown Unknown No No No No No Date of most recent LVEF Coronary artery disease Myocardial infarction Left ventricular hypertrophy Hypertension Ventricular arrhythmia % Most recent LVEF The eCRF Proposal 1: MH 0002 0005 Subject: Visit Centre: Study: CB-019 Cardiovascular Medical History SUPPMH QNAM = Evaluation of subject’s medical history for: MHOCCUR MHTERM MIDAT MINO LVEFDAT LVEFPCT

  16. STUDYID USUBJID VISITNUM MHCAT = B Company MHDTC FATEST = Date of most recent MI FAORRES = <date value> Date Medical History Taken eta FATEST = Number of MI FAORRES = <value> Date of most recent MI Number of MI FAOBJ = Yes Yes Yes Yes Yes Unknown Unknown Unknown Unknown Unknown No No No No No Date of most recent LVEF Myocardial infarction Hypertension Coronary artery disease Left ventricular hypertrophy Ventricular arrhythmia % FATEST = Date of most recent LVEF FAORRES = <datevalue> Most recent LVEF FATEST = Most recent LVEF FAORRES = <value> The eCRF Proposal 2: MH + FA 0002 0005 Subject: Visit Centre: Study: CB-019 Cardiovascular Medical History FADTC SUPPMH MHPRESP = Y Evaluation of subject’s medical history for: MHOCCUR MHTERM Proposal 1 FAOBJ = Findings FAORRESU

  17. The Discussion & The Decision B Company eta © 2010 Octagon Research Solutions, Inc. All Rights Reserved.

  18. Case Study 3 – Company Gamma

  19. Company GAMMA Background • Implementation of a CDR • Need for standard metadata for safety domains • Foundation for TA domains Snapshot of the Starting Point Standards Governance • Lightly-supported group of clinicians and statisticians for purposes of centralized decision-making for SDTM mapping • Standards governance group nearly paralyzed by workload • Limited representation led to limited buy-in to standards

  20. STUDYID USUBJID VISITNUM Company GAMMA Time Time Time Time Date Date Date Date Yes Yes Yes Yes Unknown Unknown Unknown Unknown No No No No Anticholinergics Inhaled corticosteroids Long acting Beta 2-agonists Short acting Beta 2-agonists The eCRF Proposal 1: CM 0014 0055 Subject: Visit Centre: Study: CG-203 Protocol-Restricted Medications CMCAT = ? SUPPCM PRMDAT Date of Assessment QNAM = Did the subject take the following medications during the 24 hours prior to spirometry? CMPRESP = Y CMOCCUR Last Taken CMTRT CMSTDTC

  21. STUDYID USUBJID VISITNUM Company GAMMA If PRM_NYU = Y Time Time Time Time Date Date Date Date DVTERM = PRE-SPIROMETRY INHALED CORTICOSTEROID USAGE DIVERGENT FROM PROTOCOL DVTERM = PRE-SPIROMETRY SHORT ACTING BETA 2-AGONIST USAGE DIVERGENT FROM PROTOCOL DVTERM = PRE-SPIROMETRY LONG ACTING BETA 2-AGONIST USAGE DIVERGENT FROM PROTOCOL DVTERM = PRE-SPIROMETRY ANTICHOLINERGIC USAGE DIVERGENT FROM PROTOCOL Yes Yes Yes Yes Unknown Unknown Unknown Unknown No No No No Long acting Beta 2-agonists Inhaled corticosteroids Short acting Beta 2-agonists Anticholinergics The eCRF Proposal 2: DV 0014 0055 Subject: Visit Centre: Study: CG-203 Protocol-Restricted Medications DVCAT = SUPPDV PRMDAT Date of Assessment QNAM = Did the subject take the following medications during the 24 hours prior to spirometry? Last Taken PRM_NYU DVSTDTC

  22. STUDYID USUBJID VISITNUM Company GAMMA Time Time Time Time Date Date Date Date XCTEST = PRE-SPIROMETRY INHALED CORTICOSTEROID USAGE DIVERGENT FROM PROTOCOL XCTEST = PRE-SPIROMETRY ANTICHOLINERGIC USAGE DIVERGENT FROM PROTOCOL XCTEST = PRE-SPIROMETRY SHORT ACTING BETA 2-AGONIST USAGE DIVERGENT FROM PROTOCOL XCTEST = PRE-SPIROMETRY LONG ACTING BETA 2-AGONIST USAGE DIVERGENT FROM PROTOCOL Yes Yes Yes Yes Unknown Unknown Unknown Unknown No No No No Long acting Beta 2-agonists Inhaled corticosteroids Short acting Beta 2-agonists Anticholinergics The eCRF Proposal 3: XC 0014 0055 Subject: Visit Centre: Study: CG-203 Protocol-Restricted Medications XCCAT = SUPPXC PRMDAT Date of Assessment QNAM = Did the subject take the following medications during the 24 hours prior to spirometry? XCORRES Last Taken XCDTC

  23. The Discussion & The Decision Company GAMMA © 2010 Octagon Research Solutions, Inc. All Rights Reserved.

  24. Summary

  25. Conclusion • SDTM implementation is complex, but ultimately achievable given the following: • Access to necessary expertise across functional areas • Thorough consideration of downstream analysis needs • Empowered standards governance • No single perfect method

  26. Acknowledgements Barry Cohen Dave Evans Lex Jansen Tore Haglund Stephen Harrison Harpreet Sahni

  27. Feel free to visit the Octagon booth for more information on Octagon's solutions Contact Information Ken Stoltzfus Clinical Data Strategies Octagon Research Solutions 585 East Swedesford Road, Suite 200 Wayne, PA 19087 USA Tel: 1-610-535-6500 (Ext. 5891) kstoltzfus@octagonresearch.com

  28. Questions

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