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Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences How the release of the Therapeutic Area Asthma.

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Presentation on theme: "Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences How the release of the Therapeutic Area Asthma."— Presentation transcript:

1 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences How the release of the Therapeutic Area Asthma User Guide affects an ongoing submission Nick De Donder 13 OCT 2014

2 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Agenda Introduction to Asthma Evolution of CDISC TAUG Impact on ongoing projects Conclusion

3 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Asthma Theory From the Greek ásthma = panting Chronic inflammatory disease of the airways Diagnosis classified according to: – Frequency of symptoms – Forced expiratory volume in one second (FEV1) – Peak expiratory flow rate

4 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Spirometry

5 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Agenda Introduction to Asthma Evolution of CDISC TAUG Impact on ongoing projects Conclusion

6 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Overview of CDISC Models (SEP 2014) Content Standards Technical Standards Semantics Therapeutic Areas Upcoming

7 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Therapeutic Area Handling SDTMIG 3.1.3 TU – Tumor Identification TR – Tumor Results RS – Disease Response RELREC – Related Records SDTMIG 3.2 EC - Exposure as Collected IS - Immunogenicity Assessments SR - Skin Response RD - Reproductive Details MO - Morphology MI - Microscopic Findings CV - Cardiovascular Physiology PR - Procedures TD - Trial Disease Assessments DD - Death Details SS - Subject Status SDTM 1.4 SDTMIG for Associated Persons HO - Healthcare Resource Utilization Questionnaires Alzheimer’s disease Assessment Scale – Cognitive (ADAS-Cog) Mini Mental Scale (MMSE) Audio Verbal Learning Test Version A (AVLTvA) Pain Intensity Brief Pain Inventory (BPI) EuroQol (EQ-5D) Karnofsky Performance Status Scale SF-36 Health Survey Hamilton Depression Scale Faces Pain Scale Modified Medical research Council Dyspnea (MMRC) … Therapeutic Areas Alzheimer’s Disease Asthma Multiple Sclerosis Oncology Pain Parkinson’s Disease Polycystic Kidney Disease Tuberculosis Virology

8 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 1/7 The Asthma v1.0 User Guide – Provisional version was published on 26 NOV 2013

9 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 2/7 The Asthma v1.0 User Guide contains: Existing SDTM standard domains that can be used in Asthma studies without additional development or customization: – DM (Demography) – PE (Physical Examination) – EG (ECG) – SU (Substance Use)

10 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 3/7 The Asthma v1.0 User Guide contains: Assumptions for existing SDTM standard domains at time of publication of the TAUG: – CM (Concomitant Medications) – AE (Adverse Events) – MH (Medical History) – LB (Laboratory Test Results) – FA (Findings About) For MH, AE, HO  All assumptions present in the SDTMIG are applicable  Additional assumptions added for TA Specific implementations

11 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 4/7 The Asthma v1.0 User Guide contains: Domains that are new in the next version of the SDTMIG – HO (Health Care Encounters) – SR (Skin Response)  All assumptions present in the new published SDTMIG are applicable  Domains and assumptions are subject to change or deletion without formal notice

12 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 5/7 The Asthma v1.0 User Guide contains: Domains that are not yet published in any SDTMIG at time of publication of the TAUG – AG (Procedure Agents) – RE (Respiratory System Findings)  The suggested approach present in the TAUG are applicable  Domains and assumptions are subject to change or deletion without formal notice once the domains have been published in an SDTMIG

13 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 6/7 The Asthma v1.0 User Guide contains: Assumptions and examples for SDTMIG – Medical Devices domains: – DI (Device Identifiers) – DU (Device in Use)  All assumptions present in the SDTMIG- MD are applicable  Additional assumptions added for TA Specific implementations

14 Restricted © Business & Decision Life Sciences 2014 All rights reserved. TAUG Asthma 7/7 Specific Questionnaires created for the Asthma TA

15 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Agenda Introduction to Asthma Evolution of CDISC TAUG Impact on ongoing projects Conclusion

16 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Procedure present in the SDTM IG 3.1.2 A1 Process of data integration before the release of TA Asthma User Guide Information present in the draft version of the TA Asthma User Guide SDTM Conversion of Asthma Trials

17 Restricted © Business & Decision Life Sciences 2014 All rights reserved. What’s new in the TA Asthma user guide? SDTM IG v3.1.2 A1 TA Asthma User Guide v1.0 CM: Concomitant MedicationAG: Procedure Agents HU: Healthcare Resource UtilizationHO: Healthcare Encounters SUPPHU: Supplemental Qualifiers for HUFAHO: Findings About HO Custom domain SPRE: Respiratory System Findings QS: QuestionnairesQS and FACE: Findings About Clinical Event Not presentSR: Skin Response Not presentDI: Device Identifier Not presentDU: Device-in-Use

18 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Case examples 1/4 SDTMIG V3.1.2 A1 TAUG-Asthma STUDYIDDOMAINUSUBJIDCMSEQCMTRT… XXXX-0001CMXXXX-0001-000011ALBUTEROL STUDYIDDOMAINUSUBJIDAGSEQAGTRT… XXXX-0001AGXXXX-0001-000011ALBUTEROL

19 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Case examples 2/4 SDTMIG V3.1.2 A1 TAUG-Asthma STUDYIDDOMAINUSUBJIDHUSEQHUTERM… XXXX-0001HUXXXX-0001-000011HOSPITALIZATION STUDYIDDOMAINUSUBJIDHOSEQHOTERM… XXXX-0001HOXXXX-0001-000011HOSPITALIZATION

20 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Case examples 3/4 SDTMIG V3.1.2 A1 TAUG-Asthma STUDYIDRDOMAINUSUBJIDQNAMQVAL… XXXX-0001HUXXXX-0001-00001HOREASASTHMA STUDYIDDOMAINUSUBJIDFASEQFATESTCDFAOBJ XXXX-0001FAXXXX-0001-000011OCCURHOSPITALIZATION

21 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Case examples 4/4 STUDYIDDOMAINUSUBJIDSPDEVIDRESEQRETESTCD XXXX-0001REXXXX-0001-00001ABC0011FEV1 XXXX-0001REXXXX-0001-00001ABC0012FVC XXXX-0001REXXXX-0001-00001ABC0013FEV1PP XXXX-0001REXXXX-0001-00001ABC0014FVCPP XXXX-0001REXXXX-0001-00001DEF0035PEF RETESTREORRESREORRESUREORREFRESTRESC… Forced Expiratory Volume in 1 Second 2.73L3.372.73 Forced Vital Capacity3.91L3.863.91 Percent Predicted FEV181% Percent Predicted FVC101.3% Peak Expiratory Flow6.11L/s7.336.11

22 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Different interpretation of the data How to manage dates ? Date of diagnostic vs Date of collection

23 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Agenda Introduction to Asthma Evolution of CDISC TAUG Impact on ongoing projects Conclusion

24 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Important TAUG-Asthma is a guiding document SDTMIG x.x is still the basis Nothing in the TAUG-Asthma supercedes the SDTMIG Domains published in TAUG-Asthma are draft New variables present are not part of a published model… Yet

25 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Conclusion When working on a specific TA for which the CDISC user guide is not yet released: Use of the latest SDTM IG is a good basis to follow The impact could be considered minor

26 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Thank you for your attention. Join us for a coffee at our stand. London, United Kingdom, 14 OCT 2014

27 Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences Sint-Lambertusstraat - 141 rue Saint-Lambert B-1200 Brussels T: +32 2 774 11 00 F: +32 2 774 11 99 lifesciences@businessdecision.com http://www.businessdecision-lifesciences.com/ Nick De Donder | Project Manager | +32 (0)476 82 20 27 | nick.dedonder@businessdecision.comnick.dedonder@businessdecision.com

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