Online Program

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Friday, September 14
Fri, Sep 14, 8:00 AM - 9:15 AM
Thurgood Marshall North
Basket Trial Designs, What Are We and Where Are We Going?

Designs for Biomarker-Driven Basket Clinical Trials (300658)

*Richard Simon, R Simon Consulting 

Keywords: basket, biomarker, Bayesian, subsets

Basket designs have become popular in oncology for evaluating a treatment which targets the same genomically deregulated gene or pathway in each of several types of cancer. By borrowing information among cancer type strata, basket designs can achieve a greater efficiency than performing an independent phase 2 trial for each cancer type. Basket designs can be of use in fields other than oncology for evaluating a treatment among related patient populations or in assessing multiple candidate predictive biomarkers.

I will review the several of the Bayesian Basket designs which have been developed. I will discuss some of the large basket studies that have been reported, extension of the design to randomized baskets and the role of the basket design in the regulatory pathway.