Press Release for Call for Scripts 1
In March 2012, the FDA and PhUSE jointly held an event titled “Computational Science Symposium” (CSS), which launched a series of bold initiatives to improve the collection, reporting and analysis of medical data. One such initiative was to establish an open source repository of computer programs, tools and resources that could be shared by anyone working with medical data, including pharmaceutical and biotech personnel, regulators and academics. An FDA spokesperson noted of the collaboration’s future work, “The CSS provides our FDA Reviewers and operational team an opportunity to share their experiences, collaborate with industry, and really work on the issues we have in the review process. Last year was the beginning of this great opportunity to collaborate and we hope more of our industry partners attend this year.” The advantages are numerous: time spent within individual organisations to develop systems and tools for analysis and reporting of clinical data should be reduced, if industry, regulators and academics pursue a more collaborative approach. Furthermore, if pharmaceutical industry personnel can use the same tools and approaches to analyse clinical trial data as regulators, then the results and conclusions drawn should be similar.
After a review of available options, the repository has been set up using the Google Code platform. A Call for Scripts has been issued, asking for individuals and organisations to get involved. Involvement could be as a user of code, but also we ask you to consider whether you or your organisation could contribute any programs, tools or resources. Our vision is that in the near future, the repository will become populated with useful tools, programs and resources that will be used across the statistics and computer programming community, building existing CDISC standards. However, much work still needs to be done. We have an on-going project to define what type of scripts/programs are needed, and to develop “white papers” to describe these requirements. Further calls will be issued relating to requests for development in specific topics of interest covered by these white papers. In the pharmaceutical industry, there is a perception that validated software is not compatible with an open source approach. We are continuing to work on processes to ensure that our repository can manage and store validated scripts.
Chris Decker, PhUSE FDA Liason Director, stated “The ability to have an open and central repository for code within our industry would provide the last piece of the standardization puzzle. Over the last 10 years, we have developed and implemented the CDISC data standards. Now it’s time to take that last step of standardizing our analyses and code as much as possible.”
The next FDA/PhUSE collaborative symposium takes place in a few months time. Early bird registration for industry attendees and Call for Posters ends February 15th. Please consider whether you can attend, and share this information with others who may be interested in your organisation.
If you would like to get involved and learn more about this project, please investigate these resources:
Details of the project:
The First Call for Scripts:
The Google Code Repository:
Contact the script repository managers: