TL7: Are statisticians ready to implement increasing number of platform trials?
*Emelita M. de Leon-Wong, PPDI Keywords: adaptive trials design, simulations, biomarkers, collaborative trials,Bayesian paradigm, Collaborative trials, also known as platform trials, as exemplified by I-SPY and Battle trials involve pre-competitive collaboration among sponsors with molecules/treatments at early phase of clinical development. At this stage, various molecules singly or in combinations are compared for safety and efficacy for subgroups of patients identified by biomarkers and imaging tools, under a single master protocol. This proposed roundtable will discuss the current industry landscape, including regulatory, technological and statistical requirements in conducting platform trials. Among the statistical skill sets needed are simulations, use of adaptive trial designs, real time data analysis, adaptive response randomization, automated drug forecasting,and use of Bayesian perspectives in the design, implementation and analysis of these trials. In addition, statisticians must be able to work with other functional groups in a more interactive manner to be able to implement these trials.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC