演題抄録

基調講演

開催概要
開催回
第53回・2015年・京都
 

Novel Clinical Trials for Cancer Therapy in Precision Medicine Era

演題番号 : KL6

[筆頭演者]
Lee J. Jack:1 

1:Biostatistics, University of Texas MD Anderson Cancer Center, USA

 

Rapid advancements in cancer biology, immunology, genomics, and treatment development demand innovative methods to identify better therapies and the most appropriate population in a timely, efficient, accurate, and cost-effective way. Traditional clinical trials focus on testing a small number of agents in relatively homogeneous populations without the emphasis of finding the best treatment for each patient enrolled in the trials. With next generation sequencing, no two patients have exactly the same genomic profiles. Great challenges arise to develop a myriad of agents with countless of putative prognostic and predictive biomarkers and the desire to provide most effective, tailored treatment for each patient. In my talk, I will discuss several solutions to meet these challenges including the efficient biomarker design, biomarker stratified design, adaptive enrichment design, adaptive randomization design, predictive probability design, multi-arm multi-stage adaptive design, etc. The concept of basket design, platform design, Bayesian update, and adaptive learning will also be discussed. Examples of recent trials such as the BATTLE-1 and BATTLE-2 trials, CUSTOM trial, FOCUS4 trial, I-SPY2 trial, Lung-MAP trial, NCI-Match trial, STAMPEDE trial, and WINTHER trial will be compared and contrasted to illustrate the design properties. Adaptive biomarker-driven trials can lead to a new paradigm of integrating clinical practice with clinical research to meet the goals of testing treatment efficacy, identifying and validating markers, as well as treating each patient best with precision medicine during the trial.

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