TL36: Cross-Industry Safety Analysis Recommendations for Clinical Trials and Submissions utilizing a Platform for Sharing Code
*Mat Soukup, FDA/CDER Keywords: Statistical Computing, Safety Reporting Industry standards have evolved over time for data collection (CDASH), observed data (SDTM), and analysis datasets (ADaM). Creating a consistent set of reports and analyses, at least for safety, is the natural next step in this remarkable journey. Members of an FDA/PhUSE working group are creating white papers outlining recommendations for safety analysis and reporting for clinicial trial study reports and integrated safety-related submission documents. Development of standard tables and figures with associated analyses will lead to improved product lifecycle evaluation by ensuring reviewers receive the desired analyses for the evaluation of patient safety. More importantly, having an organized process for shared learning of improved methodologies can lead to earlier safety signal detection and better characterization of the safety profile of our products. Additionally, a platform for sharing code to implement the recommendations has been created and is ready, making the standards easy to use. Crowd sourcing for code development will enable consistent interpretation of methods and substantial savings in resourcing across the industry. Attendees will learn about the progress on these efforts and will learn how they can participate in the creation and use of cross-industry analysis and reporting standards.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC