The Background

It all started when FDA had an open toolbox initiative in 2007. Then PhUSE and FDA held its first joint Computational Science Symposium (CSS) in Silver Spring, MD, USA, and Standard Analyses and Code Sharing (SACS) Working Group was formed in the same year of 2012. The main goal for the Working Group is to “leverage crowd-sourcing to improve the content and implementation of analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes”.

The Vision

Establish a platform for the collaborative development of program code to be used as analytical tools for clinical trial research, reporting, and analysis

The Goals

  • Create white papers outlining recommendations and best practices for safety analysis and reporting for clinical trial study reports and integrated safety-related submission documents
  • Establish a platform for sharing and developing standard scripts collaboratively and for implementing the recommendations through cloud services.