Statistical Methods for Clinical Trial Designs in the New Era of Cancer Treatment.

Abstract

Recent success of immunotherapy and other targeted therapies in cancer treatment has signaled the advent of precision medicine. Unlike conventional trial designs that aim to find an optimal treatment ignoring inter-patient heterogeneity, clinical trial designs for precision medicine must take into account patients' variability in genes, environments, and lifestyle. This article provides a review of recent research development of clinical trial designs toward this trend.