Simon Richard
R Simon Consulting, Potomac, Maryland.
Clin Pharmacol Ther. 2017 Dec;102(6):934-941. doi: 10.1002/cpt.814. Epub 2017 Oct 20.
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.
基于癌基因基因组改变的伴随诊断新药的成功研发，促使人们重新思考癌症药物临床开发的各个阶段。我们批判性地回顾了一些基于生物标志物的癌症药物开发的新临床试验设计。我们试图阐明这些新设计的目标，并审查使用这些设计完成的试验，以评估从这些设计中学到了什么。
