Transcript Analysis Datasets

ADaM Implementation Guide:
It’s Almost Here. Are You Ready?
Sandra Minjoe
Principal Statistical Programmer Analyst
Genentech, Inc
ADaM IG, May 2008
Outline
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Purposes for Analysis Datasets and
ADaM
Major Sections of ADaM IG
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Basic ADaM structure
ADSL
Timing of IG Release
ADaM IG, May 2008
Purposes for Analysis Datasets and
ADaM
ADaM IG, May 2008
Purposes for Analysis Datasets
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Combine data needed for specific
analysis(es)
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Allow “One Proc Away” Analysis
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Imputed data
Target windows
Selection Flags
Generated with minimal programming
Allow alternate analysis(es) and
exploration
ADaM IG, May 2008
Other Needs for Analysis Datasets
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Provide information
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How to appropriately use data
How to replicate results and explore
alternate analyses
Convey traceability
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How variables and observations were
derived
ADaM IG, May 2008
Purposes of ADaM
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Combine data across domains
Provide derived data
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Provide metadata
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Variables and observations used for
statistical analyses
Explain the analysis and results
Provide traceability
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Back to collected data
ADaM IG, May 2008
ADaM and Reviewers
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ADaM helps the reviewer trace:
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What you said you would do
What you did
Why they are different
Traceability is important
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Does NOT replace communication with
FDA
ADaM IG, May 2008
Major Sections of ADaM IG
ADaM IG, May 2008
Major Sections of ADaM IG
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ADaM Data Structure
Standard ADaM Metadata
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Categories of variables
ADSL
Implementation Issues & Solutions
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Columns vs. Rows
Examples
ADaM IG, May 2008
Basic ADaM Structure
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A vertical structure
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Includes observations for
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One record per subject per analysis
parameter per analysis time point
Observed values
Derived values required for analysis
Value-level metadata is needed
Allows flexibility
Predictable structure
ADaM IG, May 2008
Categories of Variables
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Subject Identifiers
SDTM Identifiers
ADaM Timing Identifiers (e.g. AVISIT)
ADaM Parameter Identifiers (e.g. PARAM)
ADaM Analysis Values (e.g. AVAL)
Analysis Enabling Variables
(e.g. ANLFL, TRTP)
Supportive Variables (e.g. --SEQ)
ADaM IG, May 2008
ADSL
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Subject Level Analysis Data
Required if any ADaM data is
submitted
ADaM IG, May 2008
ADSL Content
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Contains basic subject information
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Has standard names and attributes
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Demographic, baseline, disposition data
Used as source for these variables in
other analysis datasets
Tools can be built to use it
Use it for Baseline and Disposition
table programming
ADaM IG, May 2008
ADSL Structure
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Structure: 1 record per subject
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Allows simple merging with any
other dataset
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Regardless of trial design
Even SDTM
Use it for population denominators
ADaM IG, May 2008
What goes into ADSL
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Required variables
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Study identifiers
Subject demographics
Population indicator(s)
Treatment variables
Trial dates
Permissible variables
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Numeric equivalents of flags
Stratification variables
Treatment duration and compliance variables
Other key visit dates and durations
Protocol specific event information, such as
death/survival
ADaM IG, May 2008
Required ADSL Category:
Study Identifiers
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Required variables: Likely from the
SDTM DM domain
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STUDYID
USUBJID
SITEID
Optional study-specific identifiers,
e.g:
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SITEGRP (pooled group of sites used
for analysis)
ADaM IG, May 2008
Required ADSL Category:
Subject Demographics
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Required variables: Likely from the
SDTM DM domain
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AGE
SEX
RACE
Optional study-specific identifiers,
e.g.:
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AGEGRP (age group)
RACEGRP (race group)
ADaM IG, May 2008
Required ADSL Category:
Population Indicator(s)
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Required variables:
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At least one flag
Flag for each population defined in SAP
Character flag is required
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Numeric flags can be included
Some common example flags:
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FASFL (full analysis set)
ITTFL (intent-to-treat population)
PPROTFL (per-protocol population)
SAFFL (safety population)
ADaM IG, May 2008
Population Indicators:
Conversions between SDTM & ADaM
Description
ADSL indicator
variables*
FULLSET
Full analysis flag
FASFL, FASFN
ITT
Intent-to-treat
population flag
ITTFL, ITTFN
PPROT
Per-protocol
population flag
PPROTFL,
PPORTFN
SAFETY
Safety population
flag
SAFFL, SAFFN
SDTM QNAM
* Include only population flag(s) needed for analysis
ADaM IG, May 2008
Required ADSL Category:
Treatment Variables
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Required variables:
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Optional study-specific variables, e.g.:
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ARM (planned arm)
TRTP (planned treatment)
TRTA (actual treatment)
Use when subject received something other
than planned treatment
TRTxA and TRTxP
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Used instead of TRTA and TRTP
For when multiple treatment regimens are
assigned, e.g., cross-over design
ADaM IG, May 2008
Required ADSL Category:
Trial Dates
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Required SDTM variables
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Required numeric dates
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RFSTDTC and RFENDTC
Retained for reference, traceability
RANDDT (if trial is randomized)
TRTSTDT (Date of 1st treatment start)
TRTENDT (Date of last treatment end)
Format to be human-readable
If appropriate, instead use
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TRTxSTDT and TRTxENDT
Date-time if appropriate
ADaM IG, May 2008
Implementation Issues & Solutions
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Building Analysis Datasets
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Step 1: bring in data from elsewhere
Step 2: derive new data
Columns
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Step 3: clean up
ADaM IG, May 2008
Rules for Rows vs. Columns
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Add column if all data needed for
derivation is in the row
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Add row if need more than one row
to derive new information
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Change from baseline
LOCF, Average across a visit, AUC
Add row for transformations that go
across all analysis variables
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Log10
ADaM IG, May 2008
After Derivations
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How much SDTM to keep in AD?
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Consider keeping if:
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Data used to derive analysis variables
but otherwise not needed for analysis
Helps with traceability
Easy to subset to get analysis records
“Extra” data will allow for derivation of
alternate analyses
Keep audience in mind
ADaM IG, May 2008
Timing of IG Release
ADaM IG, May 2008
Timing of IG Release
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Jan 30, 2008
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March – May, 2008
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ADaM making doc modifications
May 30, 2008
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Released for internal CDISC review
Planned date for public review release
Late August, 2008
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Approximate review due date
ADaM IG, May 2008
IG Review
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Review process will be similar to
other CDISC reviews
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Spreadsheet to collect comments
Review can be done by:
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Company
Individual
Other?
ADaM IG, May 2008
IG Review
ADaM IG, May 2008
Summary
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Purposes for Analysis
Datasets/ADaM
Major Sections of ADaM IG


Basic ADaM structure
ADSL

Timing of IG Release

Questions?
ADaM IG, May 2008