Standard Analyses & Code Sharing
Working Group Overview
|Mary Nilsson||Industry Co-lead and Steering Committee Liaison||Lilly||nilsson_mary_e (at) lilly.com|
|Hanming Tu||Industry Co-lead and Steering Committee Liaison||Frontage||htu (at) frontagelab.com|
|Analysis and Display White papers (Mary Nilsson)||This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection.||Yes|
|Code Sharing (Repository) (Hanming Tu)||Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research and leading to better data interpretations and increased efficiency in the clinical drug development and review processes.||Yes|
|Communication, Promotion and Education (Jared Slain and Wendy Dobson)||The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation.||Yes|
|Best Practices for Quality Control and Validation (Maria Dalton and Jane Marrer)||Quality and accuracy is essential in the health and life sciences industries. Patients and regulators must be able to trust analyses of clinical data. This paper will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations. The paper will not discuss oversight of outsourced programming||Yes|
|GPP in Macro Development (Ninan Luke)||Macros provide an effective way to automate and reuse code in a standard and consistent manner across SAS programs. This ability to reuse code means that the use of GPP is particularly important in macro code and we think that there is a need to develop a consensus and document good programming prairies specifically for macro programming.||Yes|
|Test Data Factory (Peter Schaefer)||Several CS Projects develop and specify medical research methods, features, or processes, and some even create software components or subsystems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymized study data that are provided by project team members. The Test Data Factory project aims at providing test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts.||Yes|
- Analysis and Display White papers (Mary Nilsson)
- Code Sharing (Repository) (Hanming Tu)
- Communication, Promotion and Education (Jared Slain and Wendy Dobson)
- Best Practices for Quality Control and Validation (Maria Dalton and Jane Marrer)
- GPP in Macro Development (Ninan Luke)
- Test Data Factory (Peter Schaefer)
- PhUSE Deliverables
- 02 May 2017: Mary and Hanming gave a webinar to ASA: [ASA presentation] and [Recording]
- February 2017: The Adverse Events White Paper was finalized. The final copy is in the PhUSE Deliverables Catalog
- 25 August 2016: Draft 2 of the Adverse Events white paper is available for review until 14 October 2016. See[white paper wiki page] for instructions on how to participate in the review.
- 11 May 2016: We renamed this working group from Development of Standard Scripts for Analysis and Programming to Standard Analyses and Code Sharing.
- 10 Sep 2015: Final white paper version 1.0 of white paper on Outliers or Shifts from Normal to Abnormal: File:CS WhitePaper OutliersShifts v1.0.pdf
- 27 Aug 2015: All-hands meeting [slides]
- 09 Oct 2014: Draft 1 of the Adverse Events white paper is available for review until 01 December 2014. This review is a partial draft intended to get initial feedback on the proposed tables and figures. See the [white paper wiki page] for instructions on how to participate in the review.
- 07 Oct 2014: Version 1 of the Demographics/Disposition/Medications white paper has been finalized and available on www.phuse.eu (Publications section). The white paper is also available from the [CSS Catalog of Deliverables].
- 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
- 26 June 2014: Draft White Paper Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Submission Documents is available for review until 8 August 2014.
- 25 March 2014: Version 1 of PK white paper is available Analyses and Displays Associated to Non-Compartmental Pharmacokinetics – with a Focus on Clinical Trials.
- 18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: CSS conference
- 10 October 2013: The Central Tendency White Paper has been finalized!
- 26 June 2013: Hackathon_notes_20130626 are posted
- 01 May 2013: Individual Contributor License Agreement (Draft)
- FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
- The final draft of PhUSE Standard Scripts Update (Date Published: March 1, 2013)
- User Guide for Standard Script Repository has been drafted. (Date Published: February 28, 2013)
- The first Call for Scripts has been issued and a press release issued.
- GitHub has been chosen for our repository.
Working Group Meeting Minutes
|Year 2013||Year 2014||Year 2015||Year 2016||Year 2017||Year 2018|
- P04: Legal ownership and issues in open source repository (Sally Cassells)
- Task completed, creating a summary is planned
- P05: Create templates and metadata for documenting scripts and coding practices (Jean-Marc Ferran and Eric Sun)
- Closed, remaining tasks are folded into RGI project.
- P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
- Closed, any remaining tasks moved to Project 03
Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.
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