WG5 Charter

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Working Group 5 - Goals

  1. Support the development of validated scripts and procedures for common data transformations and analyses for use in clinical research. Scripts may be applicable across or within therapeutic areas.
  2. Enable a review environment that can absorb cutting edge analysis capabilities, extend capabilities of standard analysis packages and maintain access to high quality software to facilitate efficient and high quality reporting/review of efficacy and safety data collected in the clinical development of drugs and biologics.
  3. Develop technical requirements for an information-sharing platform that houses the scripts. Access to the platform is open to the public through a non-fee based registration via the world-wide-web.
  4. Share approaches for the analysis of clinical trials safety data to formulate a set of scripts that can form the basis of a core set of analyses to be utilized in the characterization of compound safety profiles.

Working Group 5 - Objectives

  1. Develop a platform for sharing scripts that perform data transformations, implement statistical analyses, generate graphical images, and or other analysis procedures required in the reporting of clinical trial results. The platform will:
    • Support the development of a library of scripts written in some machine-readable language (e.g. SAS, R, Stata). Scripts would be encouraged to leverage industry data standards (e.g. CDISC).
    • Encourage contributions from members of the pharmaceutical community, regulatory bodies, and academics involved in clinical research.
    • Encourage ongoing improvement of contributed scripts
    • Provide consistent documentation with sufficient detail about the required inputs and the corresponding output of scripts such that consumers of the script have a clear understanding of how to use the script and when its use is appropriate.
    • Support a library search capability.
  2. Develop metadata for contributed programs.
  3. Develop standards for specifying analyses. Network with subject matter experts to develop a list of core tables, figures, and listings (TFLs) that would be generally applicable across compounds for safety signal detection to include in a clinical study report and/or integrated summary of safety. Specifically, the core set of TFLs would include recommended assessments of adverse events. XocLaboratory measurements, vital signs, ECGs, and common topics of special interest (e.g, hepatic). Ensure scripts for the core set of TFLs are included within the library. Develop a means to communicate the core set of TFLs (e.g, white paper, meta-data within the library).
  4. Develop standards for specification of data transformations.
  5. Develop a process for registering, managing, testing and publishing scripts.
  6. Leverage existing CDISC SDTM and ADaM standards.
  7. Identify validation rules for ADaM datasets that would support successful execution of scripts.
  8. Develop a glossary of analysis terminology.
  9. Develop recommendations for a process that validates scripts.
  10. Provide test data to support validation of scripts.
  11. Contribute to the review and approval process by filling gaps while avoiding duplication of effort.

Last revision by SaschaAhrweiler,03/24/2012