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.