Keywords: safety analysis plans, crowd sourcing, integrated summaries, clinical trial reporting, data standards
The PhUSE Computational Science Analysis and Display White Papers Project is an industry-wide crowd-sourcing initiative that aims to develop recommendations on the standard analysis and reporting of common clinical trial data for regulatory submissions. Six white papers have been published to date, with the most recent paper focusing on static as well as interactive displays for adverse event data. An online platform for sharing code has also been created, making the proposed tables, figures and listings easy to implement. In this roundtable discussion, I will bring an example of the white papers so we can all get a feel for what is typically covered. Some of the questions we will discuss are the following: 1. What are the challenges of seeking industry-wide consensus on the standard analysis and reporting of common clinical trial data? Can you think of ways to overcome these challenges? 2. What are the limitations of adopting the recommendations from the white papers when developing standards for data analysis and reporting of clinical trial data? 3. How can we increase the likelihood that medical reviewers (from sponsors and regulatory agencies) become comfortable with the recommendations and know how to interpret the suggested analyses and displays? 4. How can we contribute to the development of these white papers?