Standard Analyses & Displays for Common Clinical Trial Data - An Industry-wide initiative

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Type: Roundtables
Date/Time: Monday, July 30, 2018 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section

Abstract #330063
Title: Standard Analyses and Displays for Common Clinical Trial Data -- An Industry-wide Initiative
Author(s): Mercidita Navarro
Companies: Genentech

Keywords: Safety analysis plans ; crowd sourcing ; integrated summaries ; clinical trial reporting ; data standards ; white papers project

Abstract:
The PhUSE Computational Science Analysis and Display White Papers Project, an industry-wide crowd-sourcing initiative, seeks 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. The potential impact of using WHODrug B3 Format to process medication data is addressed in Version 2 of the demographics, disposition and medications paper. The AE paper is referenced in the PhUSE Collaborations page in www.fda.gov. Ongoing topics include hepatotoxicity and questionnaire data. An online platform for sharing code is provided, making the proposed tables, figures and listings easy to implement. In this roundtable session, we would like to discuss: 1) What are the challenges of seeking industry-wide consensus on the standard analysis and reporting of common clinical trial data? 2) What are the limitations of adopting recommendations from the white papers when developing standards in our respective organizations? 3) How can we increase the likelihood that medical reviewers become comfortable with the recommendations? 4) How can we contribute to the development of the white papers?