Bridging clinical efficacy results from a laboratory assay to a validated IVD kit - a case study
View Presentation *Jonathan Shane Denne, Eli Lilly and Company Luping Zhao, Eli Lilly and Company Keywords: Bridging study; companion diagnostic tool; multiple imputation; hazard ratio When a tailored therapy and the companion diagnostic tool are not developed concurrently, a Laboratory Developed Test (LDT) may be used to identify patients in the pivotal clinical trial (CT). Upon subsequent development of a regulatory required validated In-Vitro Diagnostic (IVD), CT samples need to be re-tested. Where insufficient samples are available for retesting of all patients, a bridging study is needed to evaluating the agreement between the LDT and IVD. In an oncology drug and diagnostic tool submission, we applied statistical methods (including an analytic approach as well as multiple imputation) to estimate drug efficacy in the IVD-defined target population (IVDTP). This enables a more informative approach to bridging from an LDT to an IVD than measures of agreement alone.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC