Practical considerations with survival analysis in studies with biomarker evaluations and implications on Clinical diagnostic devices
*Sasikiran Goteti, Novartis Pharmaceuticals Corporation Keywords: biomarkers, companion diagnostics, adaptive designs In the context of clinical trials with biomarker evaluations, several aspects have to be considered at the trial design stage. Depending on the prior information available on the prognostic and predictive value of the biomarker, study population, hypothesis testing strategy, study analysis timelines in line with the companion diagnostic device development need to be evaluated. In this presentation, design strategies including adaptive designs for studies with biomarker considerations and the impact on the development of companion diagnostics will be discussed.
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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