The CDISC ADaM Team has published “Statistical
Analysis Dataset Model: General Considerations
Version 0.7” for comment. This version
is posted for general comments from September
15, 2004 to October 15, 2004. Please submit
comments using the comment spreadsheet provided
below to Dave Christiansen at davechristiansen@cableone.net.
Version 1.0.0 will incorporate comments, suggestions,
and corrections received from the general comment
period specified above and will become the official
implementation version to supersede all prior
ADaM model specifications. Each of the existing
four statistical models (Change from Baseline,
Survival, Categorical and Linear Model) will
be revised and will refer to the General Considerations
Version 1.0.0 document. Additional models, including
Baseline Characteristics and Adverse Events
will then be developed. These documents pertaining
to each statistical model will provide additional
guidance and examples for the specific statistical
methodology.
| ADaM_Guidelines_V1.pdf |
Guideline
for the Creation of Analysis Files and Documentation
of Statistical Analyses for Submission to
the FDA: This document provides guidelines
for the creation of analysis data sets and
associated documentation that are submitted
to the FDA statistical reviewer in support
of the primary and important secondary study
objectives. These guidelines discuss the
variety of issues that should be considered
when submitting information to aid the statistical
review of the submission. |
| CFB_Model_V1.pdf |
Example of Information
to be supplied for a Change From Baseline
Statistical Analysis: This first
example presents guidelines for a familiar
percent change from baseline analysis frequently
used by industry statisticians. Future examples
will present other frequently used statistical
analyses. |
| CAT_13mar03.pdf |
Example of Information
to be supplied for a Categorical Data Analysis:
This example considers the case of a binary
endpoint, such as a comparison of the proportion
of patients who respond (or fail to respond)
to treatment. |
| TTE_Model_v04242003.pdf |
Example of Information
to be supplied for a Time-to-Event Data
Analysis: This example considers
the occurrence of the first event only,
but may not preclude the development of
analysis files for analyzing recurrent event
data through straightforward extensions.
|
