Sensitivity analysis in medical device clinical trials: Case Studies
![]() Ying Yang, FDA *Yu Zhao, FDA Keywords: missing data, sensitivity analysis, medical device, clinical trial One of the major challenges in analyzing and interpreting medical device clinical trials is how to deal with the inevitable missing data which may lead to biased inference of treatment effect. Many approaches have been proposed to adjust the analysis to take into account the missing data; however, different approaches, usually based on different assumptions, may lead to different conclusions. Therefore it is necessary to investigate the robustness of study results through a range of sensitivity analyses based on different assumptions. In this presentation, we will discuss several sensitivity analysis approaches used in medical device clinical trials and present corresponding case studies.
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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