当前位置： SCI文献检索 > JAPANESE JOURNAL OF CLINICAL ONCOLOGY期刊下所有文献 > Recent innovations in the USA National Cancer Institute-sponsored investigator initiated Phase I and II anticancer drug development.

Recent innovations in the USA National Cancer Institute-sponsored investigator initiated Phase I and II anticancer drug development.

Abstract：

:Exciting recent advancements in deep-sequencing technology have enabled a rapid and cost-effective molecular characterization of patient-derived tumor samples. Incorporating these innovative diagnostic technologies into early clinical trials could significantly propel implementation of precision medicine by identifying genetic markers predictive of sensitivity to agents. It may also markedly accelerate drug development and subsequent regulatory approval of novel agents. Particularly noteworthy, a high-response rate in a Phase II trial involving a biomarker-enriched patient cohort could result in a regulatory treatment approval in rare histologies, which otherwise would not be a candidate for a large randomized clinical trial. Furthermore, even if a trial does not meet its statistical endpoint, tumors from a few responders should be molecularly characterized as part of the new biomarker-mining processes. In order to accommodate patient screening and accelerate the accrual process, institutions conducting early clinical trials need to be a part of a multi-institution clinical trials network. Future clinical trial design will incorporate new biomarkers discovered by a 'phenotype-to-genotype' effort with an appropriate statistical design. To help advance such changes, the National Cancer Institute has recently reformed the existing early phase clinical trials network. A new clinical trial network, the Experimental Therapeutics Clinical Trials Network (ET-CTN), was begun and, in addition to its pre-existing infrastructure, an up-to-date clinical trial registration system, clinical trial monitoring system including electronic database and a central Institutional Review Board were formed. Ultimately, these reforms support identifying the most appropriate therapy for each tumor type by incorporating state-of-the-art molecular diagnostic tools into early clinical trials.

journal_name

Jpn J Clin Oncol

journal_title

Japanese journal of clinical oncology

authors

Bando H,Takebe N

doi

10.1093/jjco/hyv144

subject

Has Abstract

pub_date

2015-11-01 00:00:00

pages

1001-6

issue

eissn

0368-2811

issn

1465-3621

pii

hyv144

journal_volume

pub_type

杂志文章,评审

在线工具

Recent innovations in the USA National Cancer Institute-sponsored investigator initiated Phase I and II anticancer drug development.