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A Taste of ADaM

A Taste of ADaM. Beilei Xu Accenture Changhong Shi Merck Sharp & Dohme Corp. Presented by: Peng/Zik Liu MSD (Shanghai) Pharma Co. Outline. Background ADaM Setup Steps for Lipid ADaM data Summary. Background.

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A Taste of ADaM

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  1. A Taste of ADaM Beilei Xu Accenture Changhong Shi Merck Sharp & Dohme Corp. Presented by: Peng/Zik Liu MSD (Shanghai) Pharma Co.

  2. Outline • Background • ADaM • Setup Steps for Lipid ADaM data • Summary

  3. Background • CDISC -Clinical Data Interchange Standards Consortium • SDTM - Study Data Tabulation Model • Standard for interchange of collected data • ADaM - Analysis Data Model • Standard for analysis data http://www.cdisc.org/adam

  4. ADaM Standard Data Structure • ADSL: Subject level analysis data • one record per subject • subject-level population flags, planned and actual treatment variables, demographic information, randomization factors, sub-grouping variables, and important dates • BDS: Basic Data Structure • Long and skinny structure: contains one or more records per subject, per analysis parameter, and per analysis time point • “One-proc” away readiness for analysis • Traceability

  5. BDS Variables • A central set of variables: • The analysis parameter: e.g., PARAM • The value being analyzed: e.g., AVAL and AVALC • Other variables: • Provide more information about the value being analyzed (e.g., the subject identification) • Describe and trace the derivation of the variable (e.g., DTYPE) • Enable the analyses (e.g., treatment variables, covariates)

  6. Implementation Consideration • Number of ADaM datasets needed • Derivation of analysis endpoints, analysis windows, analysis values, and imputation of missing values • Setup of analysis flags and population flags

  7. Lipid Analysis Data - ADLP • Lipid endpoints: • LDL - C • HDL - C • LDL/HDL ratio • Analysis time points: • SCREENING • BASELINE • WEEK 2 • WEEK 4 • Analysis population- Full Analysis Set

  8. Lipid Analysis Data - ADLP • Subject identifiers: STUDYID, USUBJID, SUBJID, and SITEID • Treatment variables: TRTP, TRPA, TRTPN, and TRTAN • Analysis parameter variables: PARAM, PARAMCD, PARAMN, and PARAMTYP • Analysis timing variables: ADT and ADY • The analysis value variables: AVAL, BASE, and CHG • The analysis flag variable - ANL01FL • The parameter population flag - FASPFL • The traceability variables: SRCDOM, SRCVAR, and SRCSEQ

  9. ADLP Setup Steps • Obtain Variables from Source SDTM LB Domain • Derive New Analysis Endpoints (PARAMTYP) • Handle Negatives (or under detection) and Multiple Records on the Same Date (DTYPE) • Set Analysis Flag Variables (ANLzzFL) • Compute Change, Percent Change from Baseline (BASE, CHG, PCHG) • Set Population Flag Variables

  10. Obtain Data from SDTM LB Domain SDTM LB Domain: ADLP: 10

  11. Derive New Analysis Endpoint LDL/HDL Ratio ADLP: 11

  12. Handle Multiple Records on the Same Date 12

  13. Set Analysis Flag Variables (ANLzzFL)

  14. Set Population Flag Variables

  15. One-Proc Away procmixed data=adlp; where paramcd=‘LDL’ and anl01fl=‘Y’ and faspfl=‘Y’ and avisitn in (0,2,4); class subjid avisit trta; model chg=avisit trta trta*avisit; repeated avisit/subject=subjid type=un; run;

  16. Summary • The setup steps shown above enable: • the creation of the ADaM Basic Data Structure (BDS) • traceability between analysis data and source data • "one-proc" away readiness for analysis • Further development can be made to standardize the programs for analysis data setup

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