A Compendium Platform for Reproducible Statistical Analysis and Programming, Dynamic Document in Clinical Development and Research

• Activity Number: 312
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Qinfang Steve Xiang*
• Companies: Endo Pharmaceuticals
• Keywords: Reproducible ; Statistics ; Programming ; Dynamic ; Reporting ; Clinical

Abstract

In Clinical development and research, clinical trials are playing a vital role for providing safety and efficacy. However, clinical trials usually are time-consuming, complicated, and expensive. One example in clinical trial is the process to develop the statistical analysis plan (SAP), create the analysis and reporting programs, execute the planned analysis, and report the trial results. How to effectively manage this process is always challenging. Aimed to this process, a compendium platform has developed to create the SAP, analysis output shells, the analysis programs, and trail result report. The platform brings an integrated solution for planning, analysis, and reporting. It is dynamic, reproducible, and effective. Moreover, it is simple and user friendly.