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CDISC SDTM and ADaM for survival data

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  • 1. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]CDISC SDTM and ADaMfor survival dataVI BIAS Annual ConferenceAnalisi della sopravvivenza ed applicazioni in Oncologia:un percorso dalle basi agli ultimiaggiornamentiGenoa – 30-31/10/2014Angelo TinazziCytel Inc., Wilmington Del. USASuccursale de Meyrin – Geneva – Switzerlandangelo.tinazzi@cytel.com1
  • 2. Cytel Inc. - Confidential[A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]2The information contained in thispresentation is based on personalresearch of the author and does notnecessarily represent Cytel Inc.
  • 3. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]3CDISC IntroCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesCDISC is a global, open, multidisciplinary, non-profitorganization that has established standardsto support the acquisition, exchange, submissionand archive of clinical research data andmetadata.The CDISC mission is to develop and supportglobal, platform-independent data standardsthat enable information systeminteroperability to improve medical researchand related areas of healthcare. CDISCstandards are vendor-neutral, platform-independentand freely available via the CDISCwebsite.
  • 4. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]4CDISC IntroAvailable StandardsCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 5. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]5CDISC IntroStandards in SubmissionDataAnalysisDataTabulationsDataCollectionPlanningSDTM ADaMSENDCDASHLABProtocolStudyDesignNCI CTCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 6. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]6CDISC IntroA World of Clinical StandardsCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 7. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]7CDISC IntroTraceabilityCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesPrimary Overall Survival AnalysisADTTEADaM define.xmlDMaCRFSDTM define.xml
  • 8. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]8Efficacy Endpoints in OncologySolid TumorsCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesClinical TrialEndpointDefinition SourceOverall Survival(OS)Time from randomization to death from any cause. FDAObjectiveResponse Rate(ORR)Proportion of patients achieving either a partial orcomplete response for a minimum duration of time.FDADisease-freesurvival (DFS)Time from randomization until recurrence of tumoror death from any cause. DFS is typically used inclinical trials of adjuvant cancer therapy.FDAProgression-freesurvival (PFS)Time from randomization until objective tumorprogression or death.FDATime toprogression (TTP)Time from randomization until objective tumorprogression (does not include deaths)FDATime to treatmentfailure (TTF)Time from randomization to treatmentdiscontinuation for any cause, including drugtoxicity.FDAProgression-freesurvival 2 (PFS2)Same as PFS with some indication variant. E.g. inProstate cancer-Duration ofResponse (DOR)Time from documentation of tumor response todisease progressionEMAClinical BenefitResponse Rate(CBR)Patients achieving either a complete response,partial response or absence of progression at 6monthsEMA
  • 9. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]9Efficacy Endpoint in OncologySolid TumorsRAN SD SD PR CR PDDORORROSPFS TTPDeath /AliveTTFOff TRTCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 10. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]10CDISC SDTMSDTM Domains (as per Version 3.2)CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 11. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]11CDISC SDTMDomains/Items Useful for Overall SurvivalDate of Origin / Starting pointRandomization dateTreatment Start dateCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesDSDM
  • 12. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]12CDISC SDTMDomains/Items Useful for Overall SurvivalDate of deathDMDSPatient 101001 died (DTHFL=Y) the 17JAN2013 (DTHDTC)Patient 101006 is alive (DTHFL=NULL)Patient died (DSSCAT=REPORT OF DEATH) because of Progressive Disease (DSTERM) on14DEC2010 (DSSTDTC)CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 13. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]13CDISC SDTMDomains/Items Useful for Overall SurvivalDate of last follow-up Any date documenting patient is still alive Visit date, AEs, CM, Lab Samples, ECG, etc. In SDTM we have a lot of «administrative» date that should benot considered (--DTC) Investigate for date in Supplemental QualifiersSUBJID SSORRES SSSTRESCVISIT SSDTC001001 ALIVE ALIVE FUP 1 07JAN13001001 ALIVE ALIVE FUP 2 25MAY13001002 DECEASED DEAD FUP 1 08JUN13001003 ALIVE ALIVE FUP 1 01JAN12001003 ALIVE ALIVE FUP 2 05AUG12001003 PATIENT LOSTTO FOLLOW UPLOST FUP 3 20NOV12Last follow-upDate when death was reported.Date of death in DMAt this follow-up the patient wasknown to be lost, date of lastfollow-up is therefore 05AUG12(previous visit)Survival SS Status (available from version 3.2)CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 14. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]14CDISC SDTMOncologyDomains for Tumor Response TU/TR/RSTumor IdentificationUnique identification of tumors for that patientTumor ResultsQuantitative measurements and/or qualitativeassessments of the tumors identified in the TUDisease ResponseClinical response evaluations determined from the TRdata and other SDTM domainsTUTRRS Overcoming Difficulties in Implementing RECIST criteria, PhUSE 2013, G. Ruhnke CDISC Journey on Solid Tumor Studies using RECIST 1.1., PhUSE 2013, K. Lee SDTM Oncology Domains From Patients to Data to Narrative, PhUSE 2013, K. StoltzfusCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 15. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]15CDISC SDTMOncologyDomains for Tumor Response TU/TR/RSCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 16. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]16CDISC SDTMOncologyDomains for Tumor Response TU/TR/RSCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 17. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]17CDISC SDTMOncologyDomains for Tumor Response TU/TR/RSSource: Oncology Legacy Data => SDTM.CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 18. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]18CDISC ADaMFoundationModels• One record per subject• Demographics, Baseline Chars• Study Population (ITTFL, SAFFL, ..)• Study Arm, Treatment PeriodsADSLAnalysis Subject LevelDataset• Vertical Structure• One or more record per subject/time-pointBDSBasic Data Structure• Counting of subjects with a record foreach term• It often includes a structuredhierarchy of dictionaryODSOccurrence DataStructure• Based on BDS• Time to the Event of Interest• One or more time-to-event endpointper ADTTE datasetTTETime to EventCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 19. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]19CDISC ADaMADTTE – Analysis Dataset for Time to Event – Variables of Interest Description of time-to-event (PARAMCD/PARAM) E.g. OS/Overall Survival Date Origin (STARTDT)E.g. Randomization Date Censor (CNSR) 0=Event Analysis date of event or censoring (ADT) E.g. Death Date / Last follow-up Elapsed time to the event of interest from the origin(AVAL) E.g. (ADT-STARTDT)+1 (days)CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 20. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]20CDISC ADaMADTTE – Analysis Dataset for Time to Event – Variables of Interest Event or Censoring Description (EVNTDESC) E.g. DEATH Censor Date Description (CNSDTDSC) E.g. LAST FOLLOW-UP DATE Imputation Date Flag (ADTF) E.g. D/M/YCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 21. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]21ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for CensoringA studywith Overall Survival as Primary EndpointDefinition Time from randomization until deathfrom any causeCensor Last date subject was seen aliveCut-off Date Applied: 08APR2014CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 22. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]22ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for CensoringSUBJID TRTPPARAMCDPARAM AVAL STARTDTADT ADTFCNSREVNTDESC001001 PBO OS Overall Survival(Months)16.8 15AUG11 07JAN13 0 DEATH001002 EXP OS Overall Survival(Months)8.4 12SEP11 25MAY12 D 1 LAST FOLLOW-UPDATE001003 EXP OS Overall Survival(Months)7.2 02SEP13 08APR14 1 FINALANALYSIS CUT-OFFDATEEndpoint: Overall Survival ; Cut-off Date Applied: 08APR2014TreatmentReceivedTime to EventParameter− Start Date Randomisation- Event/Censor DateTime part of the TTE event(ADT-STARTDT+1)/30.42*30.42 Standard for nr. of days in a monthEvent/CensorDescription0=Event1..n=CensorCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 23. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]23ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for CensoringSUBJID TRTPPARAMCDPARAM AVAL STARTDTADT ADTFCNSREVNTDESC001001 PBO OS Overall Survival(Months)12.1 01APR13 07JAN13 0 DEATH001002 EXP OS Overall Survival(Months)17.2 04APR13 25MAY12 D 1 LAST FOLLOW-UPDATE001003 EXP OS Overall Survival(Months)17.5 08APR13 08APR14 1 FINALANALYSIS CUT-OFFDATEEndpoint: Overall Survival ; Cut-off Date Applied: 08APR2014A partial date (--MAY12) where the day part has been imputed. Valid values are D,M,YMore details about censoring date. This patient either die or had a follow-up>cut-off dateand therefore censored at the time of analysis cut-off dateCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesThis is also traceability!!!!!!
  • 24. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]24ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for CensoringEndpoint: Overall Survival ; Cut-off Date Applied: 08APR2014SUBJIDTRTPPARAMCD… ADT ADTFCNSREVNTDESC SRCDOMSRCVAR SRCSEQ001001 PBO OS … 07JAN13 0 DEATH DM DTHDTC .001002 EXP OS … 25MAY12 D 1 LAST FOLLOW-UPDATEADSL LASTVSDT .001003 EXP OS … 08APR14 1 FINALANALYSISCUT-OFF DATEADSL LASTVSDT .SDTM.DM ADAM.ADSLCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesThis is also traceability!!!!!!
  • 25. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]25ADTTE ExamplesCase 2: Composite Endpoint with multiple value for Event and CensoringProgression Free SurvivalDefinition Time from randomization until radiologicaltumor progression or death which ever comefirstCensor Last date radiological tumor assessmentCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 26. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]26ADTTE ExamplesCase 2: Composite Endpoint with multiple value for Event and CensoringEndpoint: Progression Free SurvivalSUBJIDTRTPPARAMCDPARAM AVAL STARTDTADT CNSREVNTDESC CNSDTDSC001001 PBOPFS ProgressionFreeSurvival(Months)16.8 15AUG11 07JAN13 0 RADIOLOGICALPROGRESSION001002 EXPPFS ProgressionFreeSurvival(Months)8.4 12SEP11 25MAY12 1 STUDYCOMPLETEDLASTRADIOLOGICALASSESSMENT001003 EXPPFS ProgressionFreeSurvival(Months)7.2 02SEP13 08APR14 2 NOBASELINEASSESSMENTRANDOMIZATION001004 PBOPFS ProgressionFreeSurvival(Months)8.4 12SEP11 25MAY12 0 DEATHCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 27. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]27ADTTE ExamplesCase 3: One ADTTE with several time-to-event Endpoints Phase III study First Relapsed or Refractory Acute MyeloidLeukemia Primary Endpoint: Overall Survival Sensitivity Analysis Overall Survival censored for Susbsequent AML Therapies Overall Survival censored for Post TreatmentTransplantationCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 28. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]28ADTTE ExamplesCase 3: One ADTTE with several time-to-event EndpointsSUBJIDTRTPPARAMCDPARAM AVAL ADT CNSREVNTDESC CNSDTDSC001001 PBOAML Susbsequent AMLTherapies (Months)0.6 31AUG11 0 SUBSEQUENTAML NONPROTOCOLTHERAPY001001 PBOTRA Post TreatmentTransplantation(Months)16.8 07JAN13 1 NO EVENT LAST VISITDATE001001 PBOOS Overal Survival(Months)16.8 07JAN13 0 DEATH001001 PBOOSTROS Censored forTranspl. (Months)16.8 07JAN13 0 DEATH001001 PBOOSAMLOS Censored forSubsequent AMLTherapy (Months)0.6 31AUG11 1 NO EVENT SUBSEQUENTAML NONPROTOCOLTHERAPY DATEThe Subsequent AML therapy started on 31st August 2011. The death occurred the 7thJanuary 2013 was censored for OSAMLCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 29. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]29ADTTE ExamplesADaMDefine.xmlCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesVariable Value Label Type Format Source/Computational MethodPARAMCD PFS ProgressionFree Survival(Months)FLOAT 8.1 Analysis Date (ADT) used for ProgressionFree Survival will be the earliest date ofradiologically documented diseaseprogression (RS.RSDTC whereRS.RSTESTCD=OVRLRESP andRSORRES=PD) or death (DM.DTHDTC)If none of these events occurred AnalysisDate (ADT) is the last post-baselinetumour assessment (Max RS.RSDTC).Progression Free Survival (months)=(ADT- STARTDT+1)/30.42
  • 30. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]30ADTTE ExamplesAnalysis ResultsMetadataCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferencesAnalysis Results MetadataFieldsDescriptionDisplay Identifier Tables 14.2.1Display Name Overall Survival (months) by TreatmentResult Identifier Overall Survival (months)PARAM Overall Survival (months)PARAMCD OSAnalysis Variables AVAL, CNSRReason Primary Efficacy Endpoint as per ProtocolDataset ADTTESelection Criteria ITTFL=‘Y’ and PARAMCD=‘OS’Documentation SAP Section 10.1.1Programming Statements PROC LIFETEST DATA=ADTTE;TIME AVAL*CNSR(1);STRATA TRTP;WHERE PARAMCD=‘OS’;RUN;
  • 31. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]31ADTTE ExamplesThe Analysis Reviewer Guide: The ideal place where to clarifypotential source of misinterpretation not enough explained in the SAPCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 32. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]32ReferencesRECIST and OTHER NON SOLID TUMOR REFERENCES P Therasse et al, "New response evaluation criteria in solid tumors: RevisedRECIST guideline (version 1.1)," European Journal of Clinical Oncology, pp.45: 228-247, 2009. Overcoming Difficulties in Implementing RECIST criteria, PhUSE 2013, G.Ruhnke CDISC Journey on Solid Tumor Studies using RECIST 1.1., PhUSE 2013, K.Lee SDTM Oncology Domains From Patients to Data to Narrative, PhUSE 2013, K.Stoltzfus D Cheson et al, "Revised Recommendations of the International WorkingGroup for Diagnosis, Standardization of Response Criteria, TreatmentOutcomes, and Reporting Standards for Therapeutic Trials in Acute MyeloidLeukemia," Journal of Clinical Oncology, pp. Vol 21, No 24: pp 4642-4649,2003CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 33. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]33ReferencesONCOLOGY RELATED REGULATORY GUIDANCE Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer CancerDrugs and Biologics, FDA, 2011 Cancer Drug Approval Endpointshttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/CancerDrugs/ucm094586.htmCDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 34. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]34CDISC SDTM CDISC StandardsReferences CDISC Study Data Tabulation Model (SDTM) v1.4 Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 Associated Persons Implementation Guide (SDTMIG-AP) v1.0 Released Therapeutic Area Standards: Diabetes, Alzheimer, Asthma, Multiple Sclerosis, Pain, Parkinson Disease, Polycystic Kidney Disease,Tuberculosis and Virology Oncology for Tumor Response domains (integrated into SDTMIG 3.1.3) CDISC/NCI-EVE Standard Controlled Terminology FDA Guidance and Technical Documents: CDER and CBER: Guidance for Industry - Providing Regulatory Submissions in Electronic Format -Standardized Study Data (Draft) Study Data Specifications (soon replaced by Study Data Technical Conformance Guide) CDER Common Data Standards Issues C Holland J Shostak - Implementing CDISC Using SAS, SAS 2012 F Wood - Creating SDTM Datasets from Legacy Data - PharmaSUG - 2011 A Tinazzi - Looking for SDTM Migration Specialist – PhUSE - London 2014CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 35. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]35CDISC ADaMReferences Analysis Data Model (ADaM) Implementation Guide v1.0 The ADaM Basic Data Structure for Time-to-Event Analyses v1.0 Analysis Data Model (ADaM) Data Structure for Adverse Event Analysis G Cappellini - ADaM and traceability: Chiesi experience. BIAS Seminar «Datahandling and reporting in clinical trials with SAS» - Milan 2013 A Tinazzi - Interpreting CDISC ADaM IG through Users Interpretation. PhUSE -Bruxelles 2013CDISC IntroEfficacy Endp. OncoCDISC SDTMCDSIC ADaMADTTE ExamplesReferences
  • 36. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]36Thank you for your time!Angelo Tinazzi – Associate Director – Statistical Programmingangelo.tinazzi@cytel.com
  • 37. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]37Cytel Global ReachUSA• Cambridge, MA(HQ)• Philadelphia, PA• Waltham, MASales Offices• New York, NY• San Francisco, CAFrance• Paris (salesoffice)Switzerland• GenevaIndia• Pune• Hyderabad• Bangalore• >400 FTEs worldwide• Low turnover rate (7% in2011, 2012)UK• London (salesoffice)
  • 38. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]38
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