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临床药物试验设计的创新要点。

Innovative highlights of clinical drug trial design.

机构信息

From the Research Institute, Changshan Biochemical Pharmaceutical, Shijiazhuang, Hebei, China.

From the Research Institute, Changshan Biochemical Pharmaceutical, Shijiazhuang, Hebei, China.

出版信息

Transl Res. 2020 Oct;224:71-77. doi: 10.1016/j.trsl.2020.05.007. Epub 2020 Jun 3.

Abstract

Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials such as tedious processing duration and escalating high costs among others. To improve the efficiency of clinical studies, a spectrum of expedited clinical trial modes has been designed, and selectively implemented in contemporary drug developing landscape. Herein this article presents an update on the innovated human trial designs that are corroborated through coming up with approval of notable therapeutic compounds for clinical utilization including delivery of several blockbuster products. It is intended to inspire clinical investigators and pharmaceutical development not only timely communicating with the regulatory agencies, but also insightful translating from cutting-edge scientific discoveries.

摘要

临床试验是评估药品在获得上市许可前的疗效和安全性的金标准。然而,传统的临床试验中存在一些挑战,如繁琐的处理时间和不断增加的高成本等。为了提高临床研究的效率,已经设计了一系列加速临床试验的模式,并在当代药物开发领域中选择性地实施。本文介绍了创新的人体试验设计的最新进展,这些设计通过批准一些用于临床应用的显著治疗化合物得到了证实,包括推出了几种重磅产品。其目的是激励临床研究人员和药物开发人员不仅要及时与监管机构沟通,还要从前沿科学发现中获得有见地的信息。

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