Metadata and ADaM

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Metadata and ADaM

  1. 1. Metadata and ADaM www.cytel.com 1
  2. 2. Disclaimer Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company. www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 2
  3. 3. Agenda • Introduction of ADaM Metadata • Clincial Trial Process • Examples of how to create Metadata • Goal of ADaM Metadata • Pros and Cons • Conclusion • Questions & Answers www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 3
  4. 4. ADaM Metadata • Definition – Information of ADaM(Analysis Data Model) datasets • Types – – – – Analysis Dataset Metadata Analysis Variable Metadata Analysis Parameter Value-Level Metadata Analysis Results Metadata www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 4
  5. 5. Normal Clinical Trial Process Protocol SAP Mock Up Tables CRF DMDB www.cytel.com Raw Derived ©2012 Cytel Statistical Software & Services Pvt. Ltd. TFL 5
  6. 6. CDISC Clinical Trial Process Protocol SAP Mock Up Tables ADaM Metadata eCRF EDC SDTM ADaM TFL ADaM Related Process www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 6
  7. 7. ADaM Related Process ADaM Metadata Analysis Dataset Metadata Analysis Variable Metadata Analysis Parameter value-level Metadata ADaM www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. Analysis Results Metadata TFL 7
  8. 8. Example 1 - Time to Event Mock Up table Table 14.2.1 Time to Death by Treatment PARAM = „Days to Death‟, TRTP Analysis Population: Intent to Treat ITTFL=„Y‟ Drug 1 Drug 2 p-value __________________________________________________________________________________________ N xxx xxx Median xx xx x.xx Q1, Q3 xx, xx xx, xx __________________________________________________________________________________________ AVAL(Days to Event), CNSR(Censor information) proc lifetest data=ADTTEOS; where PARAM=“Days to Death” and ITTFL=“Y”; time AVAL*CNSR(1); strata TRTP; run; www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 8
  9. 9. Time to Event Analysis Dataset Metadata Dataset Dataset Dataset Name Description Location ADTTEOS Overall Survival Analysis Dataset www.cytel.com Dataset Structure Key Class of Documentation Variables Dataset of Dataset adtteos.xpt One record STUDYID, BDS per subject USUBJID, PARAM per parameter ©2012 Cytel Statistical Software & Services Pvt. Ltd. adtteos.txt 9
  10. 10. [CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1) Dataset Parameter Variable Variable Label Variable Display Name Identifier Name Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID ADTTEOS *ALL* USUBJID Unique Subject Identifier text $20 ADSL.USUBJID ADTTEOS *ALL* ITTFL Intent-To-Treat Population Flag text $1 Y, null ADSL.ITTFL ADTTEOS *ALL* TRTP Planned Treatment text $40 Drug 1, Drug 2 ADSL.TRT01P ADTTEOS *ALL* TRTPN Planned Treatment (N) integer 1.0 1 = Drug 1, 2 = Drug 2 ADSL.TRT01PN ADTTEOS PARAMCD PARAM Parameter text $50 Days to Death ADTTEOS *ALL* PARAMCD Parameter Code text $8 DEATH www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 10
  11. 11. [CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2) Dataset Parameter Variable Name Identifier Name Variable Label Variable Display Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT – STARTDT + 1 ADTTEOS *ALL* STARTDT YYYYMM DD10. ADSL.RANDDT ADTTEOS *ALL* ADT Time to Event integer Origin Date for Subject Analysis Date integer YYYYMM DD10. SAS Date of DS.DSDTC ADTTEOS *ALL* CNSR Censor integer 1.0 ADTTEOS *ALL* EVNTDESC Event or Censoring Description text $40 www.cytel.com 0 for DS.DSDECOD = „DEATH‟, 1 for any other study completion DEATH, COMPLETED DS.DSDECOD THE STUDY, LOST TO FOLLOW-UP, AE, PD 0, 1 ©2012 Cytel Statistical Software & Services Pvt. Ltd. 11
  12. 12. [CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event ADaM Dataset USUBJID TRTP PARAM AVAL STARTDT 001-01-001 Study Drug 1 Days to Death 157 001-01-002 Study Drug 2 Days to Death 001-01-003 Study Drug 2 001-01-004 Study Drug 1 www.cytel.com ADT CNSR EVNTDESC 2011-01-04 2011-06-10 1 COMPLETED THE STUDY 116 2011-02-01 2011-05-28 1 AE Days to Death 88 2011-02-05 2011-05-04 0 DEATH Days to Death 102 2011-03-20 2011-06-30 1 PD ©2012 Cytel Statistical Software & Services Pvt. Ltd. 12
  13. 13. Example 1 : Time to Event Analysis Results Metadata Metadata Field Metadata DISPLAY IDENTIFIER DISPLAY NAME Table 14.2.1 RESULT IDENTIFIER PARAM Days to Death PARAMCD DEATH ANALYSIS VARIABLE REASON AVAL DATASET ADTTEOS Time to Death by Treatment, Analysis Population: Intent to Treat Days to Death Primary efficacy analysis ITTFL=“Y” and PARAM = „Days to Death‟ SELECTION CRITERIA DOCUMENTATION See SAP Section XX for details. Program: t-14-012-001-death.txt PROGRAMMING STATEMENTS www.cytel.com proc lifetest data= ADTTEOS; where ITTFL=„Y‟ and PARAM = “Days to Death”; time AVAL*CNSR(1); strata TRTP; run; ©2012 Cytel Statistical Software & Services Pvt. Ltd. 13
  14. 14. Example 2 : Time to Event Mock Up table Table 14.2.2 Time to Progression Free Survival : Cox Proportional Hazard Model PARAM = ‘Days to Progression Free Survival’, TRTP Analysis Population: Intent to Treat ITTFL=„Y‟ Drug 1 Drug 2 p-value __________________________________________________________________________________________ N xxx xxx Median xx xx x.xx Q1, Q3 xx, xx xx, xx __________________________________________________________________________________________ AVAL(Days to Event), CNSR(Censor information) proc phreg data=ADTTEOS; where PARAM=“Days to Progression Free Survival” and ITTFL=“Y”; model AVAL*CNSR(1) = TRTP AGE SEX ; run; www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 14
  15. 15. [CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 2 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1) Dataset Parameter Variable Variable Label Variable Display Name Identifier Name Type Format Source / Derivation Codelist / Controlled Terms ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID ADTTEOS *ALL* USUBJID Unique Subject Identifier text $20 ADSL.USUBJID ADTTEOS *ALL* ADTTEOS *ALL* ADTTEOS *ALL* AGE SEX ITTFL Age Sex Intent-To-Treat Population Flag integer text text 3.0 $1 $1 Y, null ADSL.AGE ADSL.SEX ADSL.ITTFL ADTTEOS *ALL* TRTP Planned Treatment text $40 Drug 1, Drug 2 ADSL.TRT01P ADTTEOS *ALL* TRTPN Planned Treatment (N) integer 1.0 1 = Drug 1, 2 = Drug 2 ADSL.TRT01PN ADTTEOS PARAMCD PARAM Parameter text $50 ADTTEOS *ALL* PARAMCD Parameter Code text Days to Death Days to Progression Free Survival DEATH PFS www.cytel.com $8 ©2012 Cytel Statistical Software & Services Pvt. Ltd. 15
  16. 16. Example 2 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2) Dataset Parameter Variable Name Identifier Name Variable Label Variable Display Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT – STARTDT + 1 ADTTEOS *ALL* STARTDT YYYYMM DD10. ADSL.RANDDT ADTTEOS *ALL* ADT Time to Event integer Origin Date for Subject Analysis Date integer YYYYMM DD10. SAS Date of DS.DSDTC ADTTEOS DEATH CNSR Censor integer 1.0 ADTTEOS PFS CNSR Censor integer 1.0 ADTTEOS *ALL* EVNTDESC Event or Censoring Description text $40 www.cytel.com 0 for DS.DSDECOD = „DEATH‟, 1 for any other study completion 0, 1 0 for DS.DSDECOD in(„DEATH‟ , „PD‟), 1 for any other study completion DEATH, COMPLETED DS.DSDECOD THE STUDY, LOST TO FOLLOW-UP, AE, PD 0, 1 ©2012 Cytel Statistical Software & Services Pvt. Ltd. 16
  17. 17. [CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 2 : Time to Event ADaM Dataset USUBJ AGE SEX TRTP ID PARAM AVA STAR L TDT ADT CNSR EVNTDESC 001-01001 43 M Study Drug 1 Days to Death 157 201101-04 201106-10 1 COMPLETED THE STUDY 001-01002 57 F Study Drug 2 Days to Death 116 201102-01 201105-28 1 AE 001-01003 71 M Study Drug 2 Days to Death 88 201102-05 201105-04 0 DEATH 001-01004 55 F Study Drug 1 Days to Death 102 201103-20 201106-30 1 PD 001-01001 43 M Study Drug 1 Days to Progression 157 Free Survival 201101-04 201106-10 1 COMPLETED THE STUDY 001-01002 57 F Study Drug 2 Days to Progression 116 Free Survival 201102-01 201105-28 1 AE 001-01003 71 M Study Drug 2 Days to Progression 88 Free Survival 201102-05 201105-04 0 DEATH 001-01004 55 F Study Drug 1 Days to Progression 102 Free Survival 201103-20 201106-30 0 PD www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 17
  18. 18. Example 2 : Time to Event Analysis Results Metadata Metadata Field Metadata DISPLAY IDENTIFIER DISPLAY NAME Table 14.2.2 RESULT IDENTIFIER PARAM Days to Progression Free Survival PARAMCD PFS ANALYSIS VARIABLE REASON AVAL DATASET ADTTEOS Time to Progression Free Survival : Cox Proportional Hazard Model Days to Progression Free Survival Secondary efficacy analysis ITTFL=“Y” and PARAM=“Days to Progression Free Survival‟ SELECTION CRITERIA DOCUMENTATION See SAP Section XX for details. Program: t-14-002-002-pfs.txt PROGRAMMING STATEMENTS www.cytel.com proc phreg data= ADTTEOS; where ITTFL=„Y‟ and PARAM = “Days to Progression Free Survival’; model AVAL*CNSR(1) = TRTP AGE SEX; run; ©2012 Cytel Statistical Software & Services Pvt. Ltd. 18
  19. 19. Summary of Examples Mock Up Tables ADaM Metadata 14.2.1 14.2.2 Dataset ADTTEOS Variables STUDYDI, USUBJID ITTFL TRTP, TRTPN PARAM, PARAMCD AVAL STARTDT, ADT CNSR EVNTDESC AGE SEX Parameter DEATH Results Days to Death www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. PFS Days to Progression Free Survival 19
  20. 20. Goal of Metadata • Serve as Spec and Define – Spec : provide the programmers how ADaM and some TFL can be created – Define : datasets information for sponsors • Central document for all programmers and statisticians www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 20
  21. 21. Goal of Metadata (2) • Minimize the communication traffic in virtual office setting – – – – Philadelphia Office Boston Office India Office Remote Programming • Reconciliation between ADaM datasets and Metadata – use macros to check wether ADaM datasets follow ADaM Metadata. www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 21
  22. 22. Cons • Who will prepare and maintain the metadata • CDISC expert(SDTM, ADaM and so on) • Programmer Lead • Statistician • The initial investment on resource and time at the early stage of the study • Two many metadata? www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 22
  23. 23. Pros (1) • Consistency in ADaM datasets – – – – Label Name Format # of variables • Help the inexperience personnel – ADaM is new • The central document between developers and validators – especially for the virtual office setting • Helps the programmers on efficacy analysis. www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 23
  24. 24. Pros (2) • Better estimate on the number of ADaM datasets – help the planning and resourcing. • Review on Mock Up tables and SAP www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 24
  25. 25. Conclusion • The concept of Metadata is “Plan your work and work your plan” • ADaM Metadata is ongoing until all are done. www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 25
  26. 26. Questions? www.cytel.com ©2012 Cytel Statistical Software & Services Pvt. Ltd. 26

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