Simon Richard
a R Simon Consulting , Potomac , MD , USA.
J Biopharm Stat. 2018;28(2):245-255. doi: 10.1080/10543406.2017.1372779. Epub 2017 Oct 30.
The established molecular heterogeneity of human cancers has had profound effects on the design of cancer therapeutics. Most cancer drugs are today targeted to molecular alterations present in cancer cells. Tumors of the same primary site, however, often differ with regard to the alterations that they harbor. Consequently, this heterogeneity has required the development of new paradigms for clinical development. In this paper, we review some clinical trial designs finding active use in co-development of therapeutics and predictive biomarkers to inform their use in oncology.
人类癌症中已确定的分子异质性对癌症治疗方法的设计产生了深远影响。如今，大多数癌症药物都是针对癌细胞中存在的分子改变。然而，同一原发部位的肿瘤在其所具有的改变方面往往存在差异。因此，这种异质性需要开发新的临床开发模式。在本文中，我们回顾了一些在治疗药物和预测性生物标志物联合开发中得到积极应用的临床试验设计，以为其在肿瘤学中的应用提供参考。
