Critical Review of Umbrella, Basket, and Platform Designs for Oncology Clinical Trials.

The successful development of new drugs with a companion diagnostic based on genomic alteration of an oncogene has led to rethinking of all phases on clinical development of cancer drugs. We critically review some of the new clinical trial designs for biomarker-based cancer drug development. We try to clarify the objectives of the new designs and examine completed trials using these designs to evaluate what has been learned about these designs.