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GSK

The content of this blog expresses opinions solely of the author and not necessarily those of their employer or PhUSE.

The FDA’s Computational Science Center in collaboration with PhUSE has set up a public repository for open source scripts (computer programs, tools, resources) to help manage, summarize, explore, analyze and report clinical trial data. We encourage you and your organization to get involved in this exciting project to build an industry wide standards repository if

  • you have existing scripts that could be shared with the statistical computing community
  • you or your organisation have the time and/or resources to create new scripts

Any scripts that may be of interest and use to the statistical programming community can be added to the repository. For example, these could be:

  • Scripts for producing standard tables, graphs or listings based on CDISC ADaM datasets.
  • Scripts for developing ADaM datasets from SDTM datasets.
  • Scripts for patient profile graphs
  • Scripts used to investigate drug safety

Additionally the group is in the process of developing a set of White Papers that will describe areas of special interest for script development. These can be found on this PhUSE Wiki page.

The repository will be the home of a wide array of tools and resources that can be used in clinical research. It is one of our goals that the scripts build on existing CDISC standards thus making the repository a catalyst for standardized reporting of clinical trial data. The scripts can be in any computer language (e.g. R/SAS/S+/STATA/C++/java).

Google Code has been set up as a platform to host and to develop the scripts. All scripts will be available to the public under the MIT open source licence. Once scripts are added into the system, they can be enhanced and improved by the statistical computing community. A working group is developing further processes to flag scripts as tested or validated in the system. Issues with scripts can be tracked and fixed by the community of users. All scripts will be available publicly without any cost.

Regulators as well as the industry will benefit from a common repository of scripts that can be used both in clinical development as well as by regulators in the review and approval process. You can find out more information on the initiative on the PhUSE Wiki Pages: www.phusewiki.org.

If you would like to start sharing your code today go to https://code.google.com/p/phuse-scripts/ and follow the instructions from the User Guide

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