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Critical Review of Umbrella, Basket, and Platform Designs for Oncology Clinical Trials
Author(s) -
Simon Richard
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.814
Subject(s) - clinical trial , drug development , medicine , clinical oncology , clinical study design , biomarker , precision oncology , cancer drugs , cancer , medical physics , oncology , intensive care medicine , drug , pharmacology , biology , biochemistry
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.