The FDA’s Computational Science Center, in collaboration with PhUSE, has set up a public repository for open-source scripts (computer programs, tools, and related resources) to help manage, summarize, explore, analyze, and report clinical trial data.
This is an effort started at the 2012 FDA/PhUSE Computational Science Symposium. I’ve been involved with a variety of statistical programmers across the globe in setting up this repository, and I am pleased to post this call for scripts.
Any scripts that may be useful to the statistical programming community can be added to the repository. For example, these could be scripts for the following:
• Producing standard tables, graphs, or listings based on CDISC ADaM datasets
• Developing ADaM datasets from SDTM datasets
• Creating patient-profile graphs
• Investigating 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 assortment of tools and resources that can be used in clinical research. One of this project’s goals is 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, such as R, SAS, S+, STATA, C++, or 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 license. After scripts are added into the system, they can be enhanced and improved by the statistical programming community. A working group is developing further processes to flag scripts as qualified (what you might consider “validated.”) Issues with scripts can be tracked and fixed by the community of users. All scripts will be available publicly without any cost.
Regulators and the pharmaceutical industry will benefit from a common repository of scripts that can be used in clinical development as well as by regulators in the review and approval process. You can find more information on the initiative on the PhUSE Wiki Pages.
If you would like to start sharing your code, go to the code repository and follow the instructions from the User Guide.
Also, you can contact me for more information!