cdisc sdtm and adam for survival data
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Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
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CDISC SDTM and ADaM for survival data
VI BIAS Annual Conference
Analisi della sopravvivenza ed applicazioni in Oncologia: un percorso dalle basi agli ultimiaggiornamenti
Genoa – 30-31/10/2014
Angelo TinazziCytel Inc., Wilmington Del. USA
Succursale de Meyrin – Geneva – [email protected]
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Cytel Inc. - Confidential
The information contained in this presentation is based on personal
research of the author and does not necessarily represent Cytel Inc.
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CDISC Intro
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
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. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.
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CDISC IntroAvailable Standards
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
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CDISC IntroStandards in Submission
Data Analysis
Data Tabulations
Data CollectionPlanning
ADaMSDTM
SEND
CDASH
LAB
Protocol
StudyDesign NCI CT
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC IntroA World of Clinical Standards
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC IntroTraceability
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Primary Overall Survival Analysis
ADTTE
ADaM define.xml
DM
SDTM define.xml
aCRF
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Efficacy Endpoints in OncologySolid Tumors
Clinical Trial Endpoint
Definition Source
Overall Survival (OS)
Time from randomization to death from any cause. FDA
Objective Response Rate (ORR)
Proportion of patients achieving either a partial or complete response for a minimum duration of time.
FDA
Disease-free survival (DFS)
Time from randomization until recurrence of tumor or death from any cause. DFS is typically used in clinical trials of adjuvant cancer therapy.
FDA
Progression-free survival (PFS)
Time from randomization until objective tumor progression or death.
FDA
Time to progression (TTP)
Time from randomization until objective tumor progression (does not include deaths)
FDA
Time to treatment failure (TTF)
Time from randomization to treatment discontinuation for any cause, including drug toxicity.
FDA
Progression-free survival 2 (PFS2)
Same as PFS with some indication variant. E.g. in Prostate cancer
-
Duration of Response (DOR)
Time from documentation of tumor response to disease progression
EMA
Clinical Benefit Response Rate (CBR)
Patients achieving either a complete response, partial response or absence of progression at 6 months
EMA
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Clinical Trial Endpoint
Definition Source
Overall Survival (OS)
Time from randomization to death from any cause. FDA
Objective Response Rate (ORR)
Proportion of patients achieving either a partial or complete response for a minimum duration of time.
FDA
Disease-free survival (DFS)
Time from randomization until recurrence of tumor or death from any cause. DFS is typically used in clinical trials of adjuvant cancer therapy.
FDA
Progression-free survival (PFS)
Time from randomization until objective tumor progression or death.
FDA
Time to progression (TTP)
Time from randomization until objective tumor progression (does not include deaths)
FDA
Time to treatment failure (TTF)
Time from randomization to treatment discontinuation for any cause, including drug toxicity.
FDA
Progression-free survival 2 (PFS2)
Same as PFS with some indication variant. E.g. in Prostate cancer
-
Duration of Response (DOR)
Time from documentation of tumor response to disease progression
EMA
Clinical Benefit Response Rate (CBR)
Patients achieving either a complete response, partial response or absence of progression at 6 months
EMA
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RAN SD SD PR CR PD
DOR
ORR
OS
PFS TTP
Death /Alive
TTF
Off TRT
Efficacy Endpoint in OncologySolid Tumors
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMSDTM Domains (as per Version 3.2)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMDomains/Items Useful for Overall Survival
Date of Origin / Starting pointRandomization date
Treatment Start date
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
DS
DM
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CDISC SDTMDomains/Items Useful for Overall Survival
Date of deathDM
DS
Patient died (DSSCAT=REPORT OF DEATH) because of Progressive Disease (DSTERM) on 14DEC2010 (DSSTDTC)
Patient 101001 died (DTHFL=Y) the 17JAN2013 (DTHDTC)
Patient 101006 is alive (DTHFL=NULL)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMDomains/Items Useful for Overall Survival
Date of last follow-upAny 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 be
not considered (--DTC) Investigate for date in Supplemental Qualifiers
SUBJID SSORRES SSSTRESC
VISIT SSDTC
001001 ALIVE ALIVE FUP 1 07JAN13
001001 ALIVE ALIVE FUP 2 25MAY13
001002 DECEASED DEAD FUP 1 08JUN13
001003 ALIVE ALIVE FUP 1 01JAN12
001003 ALIVE ALIVE FUP 2 05AUG12
001003 PATIENT LOST TO FOLLOW UP
LOST FUP 3 20NOV12
Last follow-up
Date when death was reported. Date of death in DM
At this follow-up the patient was known to be lost, date of last follow-up is therefore 05AUG12 (previous visit)
Survival Status (available from version 3.2)SS
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMOncology Domains for Tumor Response TU/TR/RS
Tumor IdentificationUnique identification of tumors for that patient
Tumor ResultsQuantitative measurements and/or qualitativeassessments of the tumors identified in the TU
Disease ResponseClinical response evaluations determined from the TRdata and other SDTM domains
TU
TR
RS
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
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMOncology Domains for Tumor Response TU/TR/RS
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMOncology Domains for Tumor Response TU/TR/RS
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTMOncology Domains for Tumor Response TU/TR/RS
Source: Oncology Legacy Data => SDTM.
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC ADaMFoundation Models
• One record per subject• Demographics, Baseline Chars• Study Population (ITTFL, SAFFL, ..)• Study Arm, Treatment Periods
ADSL
Analysis Subject Level Dataset
• Vertical Structure• One or more record per subject/time-
point
BDS
Basic Data Structure
• Counting of subjects with a record for each term
• It often includes a structured hierarchy of dictionary
ODS
Occurrence Data Structure
• Based on BDS• Time to the Event of Interest• One or more time-to-event endpoint
per ADTTE dataset
TTE
Time to Event
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC 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 DateCensor (CNSR) 0=EventAnalysis date of event or censoring (ADT)
E.g. Death Date / Last follow-upElapsed time to the event of interest from the origin
(AVAL)E.g. (ADT-STARTDT)+1 (days)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC 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/Y
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for Censoring
Definition Time from randomization until death from any cause
Censor Last date subject was seen alive
A study with Overall Survival as Primary Endpoint
Cut-off Date Applied: 08APR2014
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for Censoring
SUBJID TRTP
PARAMCD
PARAM AVAL STARTDT
ADT ADTF
CNSR
EVNTDESC
001001 PBO OS Overall Survival (Months)
16.8 15AUG11 07JAN13 0 DEATH
001002 EXP OS Overall Survival (Months)
8.4 12SEP11 25MAY12 D 1 LAST FOLLOW-UP DATE
001003 EXP OS Overall Survival (Months)
7.2 02SEP13 08APR14 1 FINAL ANALYSIS CUT-OFF DATE
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
Treatment Received
Time to Event Parameter
Time part of the TTE event(ADT-STARTDT+1)/30.42*30.42 Standard for nr. of days in a month
− Start Date Randomisation- Event/Censor Date
0=Event1..n=Censor
Event/Censor Description
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for Censoring
SUBJID TRTP
PARAMCD
PARAM AVAL STARTDT
ADT ADTF
CNSR
EVNTDESC
001001 PBO OS Overall Survival (Months)
12.1 01APR13 07JAN13 0 DEATH
001002 EXP OS Overall Survival (Months)
17.2 04APR13 25MAY12 D 1 LAST FOLLOW-UP DATE
001003 EXP OS Overall Survival (Months)
17.5 08APR13 08APR14 1 FINAL ANALYSIS CUT-OFF DATE
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
A partial date (--MAY12) where the day part has been imputed. Valid values are D,M,Y
More details about censoring date. This patient either die or had a follow-up>cut-off date and therefore censored at the time of analysis cut-off date
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
This is also traceability!!!!!!
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ADTTE ExamplesCase 1: Single Endpoint with Multiple Values for Censoring
SUBJID
TRTP
PARAMCD
… ADT ADTF
CNSR
EVNTDESC SRCDOM
SRCVAR SRCSEQ
001001 PBO OS … 07JAN13 0 DEATH DM DTHDTC .
001002 EXP OS … 25MAY12 D 1 LAST FOLLOW-UP DATE
ADSL LASTVSDT .
001003 EXP OS … 08APR14 1 FINAL ANALYSIS CUT-OFF DATE
ADSL LASTVSDT .
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
SDTM.DM ADAM.ADSL
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
This is also traceability!!!!!!
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ADTTE ExamplesCase 2: Composite Endpoint with multiple value for Event and Censoring
Definition Time from randomization until radiological tumor progression or death which ever come first
Censor Last date radiological tumor assessment
Progression Free Survival
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 2: Composite Endpoint with multiple value for Event and Censoring
SUBJID
TRTP
PARAMCD
PARAM AVAL STARTDT
ADT CNSR
EVNTDESC CNSDTDSC
001001 PBO
PFS Progression Free Survival(Months)
16.8 15AUG11 07JAN13 0 RADIOLOGICAL PROGRESSION
001002 EXP
PFS Progression Free Survival(Months)
8.4 12SEP11 25MAY12 1 STUDY COMPLETED
LAST RADIOLOGICAL ASSESSMENT
001003 EXP
PFS Progression Free Survival(Months)
7.2 02SEP13 08APR14 2 NO BASELINE ASSESSMENT
RANDOMIZATION
001004 PBO
PFS Progression Free Survival(Months)
8.4 12SEP11 25MAY12 0 DEATH
Endpoint: Progression Free Survival
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 3: One ADTTE with several time-to-event Endpoints
Phase III studyFirst Relapsed or Refractory Acute Myeloid
LeukemiaPrimary Endpoint: Overall SurvivalSensitivity Analysis
Overall Survival censored for Susbsequent AML TherapiesOverall Survival censored for Post Treatment
Transplantation
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesCase 3: One ADTTE with several time-to-event Endpoints
SUBJID
TRTP
PARAMCD
PARAM AVAL ADT CNSR
EVNTDESC CNSDTDSC
001001 PBO
AML Susbsequent AML Therapies (Months)
0.6 31AUG11 0 SUBSEQUENT AML NON PROTOCOL THERAPY
001001 PBO
TRA Post Treatment Transplantation (Months)
16.8 07JAN13 1 NO EVENT LAST VISIT DATE
001001 PBO
OS Overal Survival(Months)
16.8 07JAN13 0 DEATH
001001 PBO
OSTR
OS Censored for Transpl. (Months)
16.8 07JAN13 0 DEATH
001001 PBO
OSAML
OS Censored for Subsequent AML Therapy (Months)
0.6 31AUG11 1 NO EVENT SUBSEQUENT AML NON PROTOCOL THERAPY DATE
The Subsequent AML therapy started on 31st August 2011. The death occurred the 7th January 2013 was censored for OSAML
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ADTTE ExamplesADaM Define.xml
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Variable Value Label Type Format Source/Computational Method
PARAMCD PFS Progression Free Survival (Months)
FLOAT 8.1 Analysis Date (ADT) used for Progression Free Survival will be the earliest date of radiologically documented disease progression (RS.RSDTC where RS.RSTESTCD=OVRLRESP and RSORRES=PD) or death (DM.DTHDTC)
If none of these events occurred Analysis Date (ADT) is the last post-baseline tumour assessment (Max RS.RSDTC).
Progression Free Survival (months)=(ADT - STARTDT+1)/30.42
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ADTTE ExamplesAnalysis Results Metadata
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Analysis Results Metadata Fields
Description
Display Identifier Tables 14.2.1
Display Name Overall Survival (months) by Treatment
Result Identifier Overall Survival (months)
PARAM Overall Survival (months)
PARAMCD OS
Analysis Variables AVAL, CNSR
Reason Primary Efficacy Endpoint as per Protocol
Dataset ADTTE
Selection Criteria ITTFL=‘Y’ and PARAMCD=‘OS’
Documentation SAP Section 10.1.1
Programming Statements PROC LIFETEST DATA=ADTTE; TIME AVAL*CNSR(1); STRATA TRTP; WHERE PARAMCD=‘OS’;RUN;
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ADTTE ExamplesThe Analysis Reviewer Guide: The ideal place where to clarify
potential source of misinterpretation not enough explained in the SAPCDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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RECIST and OTHER NON SOLID TUMOR REFERENCES P Therasse et al, "New response evaluation criteria in solid tumors: Revised
RECIST 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 Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia," Journal of Clinical Oncology, pp. Vol 21, No 24: pp 4642-4649, 2003
References
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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ONCOLOGY RELATED REGULATORY GUIDANCE Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Cancer
Drugs and Biologics, FDA, 2011
Cancer Drug Approval Endpoints http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/CancerDrugs/ucm094586.htm
References
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC SDTM CDISC Standards
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 2014
References
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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CDISC ADaM 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 «Data handling and reporting in clinical trials with SAS» - Milan 2013
A Tinazzi - Interpreting CDISC ADaM IG through Users Interpretation. PhUSE - Bruxelles 2013
References
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
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Thank you for your time!
Angelo Tinazzi – Associate Director – Statistical Programming
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