• Transl Res · Oct 2020

    Review

    Innovative highlights of clinical drug trial design.

    • Daohong Chen and Eric Yining Qi.
    • From the Research Institute, Changshan Biochemical Pharmaceutical, Shijiazhuang, Hebei, China. Electronic address: daohong.chen@hbcsbio.com.
    • Transl Res. 2020 Oct 1; 224: 71-77.

    AbstractClinical 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.Copyright © 2020 Elsevier Inc. All rights reserved.

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