Progress toward the implementation of a molecular characterization paradigm in cancer drug development over the past 20 years has markedly enhanced our capability to select patients who are more likely to benefit from cancer therapy. Improvements in genomic and related diagnostic testing platforms have permitted evaluation of the efficacy of treatment assignment based on predefined biologic features of a patient's tumor or germline using master protocols that may include many malignancies and their molecularly characterized subsets. With this approach, a wide range of new targeted and immunologic treatment approaches have been defined for patients who, heretofore, lacked effective therapeutic options.
Keywords: Basket trial; Bucket trial; Cancer drug development; Master protocol; Precision oncology.
Published by Elsevier Inc.