The important work conducted in 2013 is "…connected to strategic goal that PhUSE becomes the industry voice to regulatory agencies and standards organizations."
Silver Spring, Maryland (PRWEB) January 12, 2014
The PhUSE Computational Science Symposium Working Group on the development of Standard Scripts has been active in 2013 in pursuing its goal to begin standardizing clinical data analyses across the Pharmaceutical and Biotech industries. The working group comprises members from industry and academia, and receives input from the US Food and Drug Administration.
In October, the Working Group announced the release of its first white paper, providing advice on Central Tendency Analyses with a focus on Safety. The white paper release provided recommended standard tables and figures for measures of central tendency for a common set of safety measurements.
The authors of the white paper gave insight into the value of standard analysis scripts, stating that "Development of standard Tables, Figures, and Listings (TFLs) and associated analyses will lead to improved standardization from collection through data storage … the development of standard TFLs will also lead to improved product lifecycle management by ensuring reviewers receive the desired analyses for the consistent and efficient evaluation of patient safety and drug effectiveness."
The white paper on Central Tendency Analyses will be used as basis for PhUSE's first ever "Script-athon," to be held at the PhUSE Computational Sciences Symposium, in March 2014, in Silver Spring, Maryland, USA. The Script-athon will challenge programmers to collaborate to create standard scripts using code languages such as SAS and R. Targets for standard analysis and reporting scripts will be selected from the white paper. PhUSE supports an open and collaborative environment, and the outputs of the Script-athon will be stored in the PhUSE Standard Scripts working group code repository.
In addition to hosting the Script-athon, the working group will continue to focus on the creation of further white papers in 2014. The working group is keen to engage new voices from industry and academia to contribute to this work.
The important work conducted in 2013 is "…connected to strategic goal that PhUSE becomes the industry voice to regulatory agencies and standards organizations," said Mary Nilsson, industry co-lead of the Standard Scripts working group.
PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical data science. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and clinical data scientists.