Handling of Missing Data for Composite Endpoints in Clinical Trials
![]() *Hui Quan, Sanofi Ji Zhang, Sanofi Keywords: Missing at Random, ITT, EM algorithm, MLE Composite endpoints are often used in clinical trials in order to increase the study power through the reduction of endpoint variability or the increase of the number of events. Just as any study endpoints, missing data can occur in the components of a composite endpoint. If a patient has missing data in some of the components but not all the components, this patient may have incomplete data but partial data for the composite endpoint. The commonly used naïve methods may completely discard the patient from the analysis. To be consistent with the intention-to-treat principle, partial data from the patient should be included in the analysis. In this presentation, we discuss approaches for the analysis of composite endpoints with missing data in components focusing on binary endpoints. The main idea is to first derive the probabilities of all possible study outcomes and then to construct the overall rate for the composite endpoint. Simulation results are presented to compare the proposed approach with two naïve methods. A trial example is used to illustrate the application of the approach.
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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