FDA/PhUSE WG 5

1
FDA/PhUSE WG 5

• Development of Standard Scripts for Analysis
  Programming
• Goals and Objectives

2
Goals and Objectives

• Developed by WG leadership team
• Posted on WG 5 Wiki
• http//www.phusewiki.org/wiki/index.php?titleWG5_
  Charter
• Provide a starting point and focus for March F2F
  sessions.

3
Goals

• Support development of validated scripts
• Enable use of cutting edge analysis techniques
  within the review environment
• Develop technical requirements for a non-fee
  based platform that houses the scripts
• Share approaches for analysis of clinical trials
  safety data to develop a core set of analyses for
  characterization of compound safety profiles.

4
Objectives

• Develop a platform for sharing scripts that will
• Support development of script library that
  leverages industry data standards.
• Encourage script contributions from the
  pharmaceutical community, regulators and
  academics.
• Encourage ongoing improvement of contributed
  scripts.
• Provide documentation with sufficient detail that
  consumers know how and when to use the script.
• Support a library search capability.
• Develop metadata for contributed programs.
• Develop standards for specifying analysis.
  Network with subject matter experts to develop a
  list of core tables figures and listings
  applicable across compounds.

5
Objectives

1. Develop standards for specification of data
   transforms.
2. Develop a process for registering, managing,
   testing and publishing scripts.
3. Leverage existing CDISC SDTM and ADaM standards.
4. Identify validation rules for ADaM datasets that
   would support successful execution of scripts.
5. Develop a glossary of analysis terminology.
6. Develop recommendations for a process that
   validates scripts.
7. Provide test data to support validation of
   scripts.
8. Contribute to the review and approval process by
   filling gaps while avoiding duplication of effort.

6
WG5 Subgroups

1. What scripts do we want/need?
2. Creation and validation of scripts
3. Platform for script management