Innovative highlights of clinical drug trial design
| Autor: | Eric Yining Qi, Daohong Chen |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
bio-equivalence
0301 basic medicine Drug trial Orphan Drug Production MEDLINE Human trial Marketing authorization Article 03 medical and health sciences 0302 clinical medicine Inventions Physiology (medical) Humans adaptive design Medicine Duration (project management) Clinical Trials as Topic business.industry Biochemistry (medical) Drug Repositioning Public Health Environmental and Occupational Health General Medicine orphan drug Clinical trial 030104 developmental biology Therapeutic Equivalency Risk analysis (engineering) 030220 oncology & carcinogenesis business |
| Zdroj: | Translational Research |
| ISSN: | 1931-5244 |
| DOI: | 10.1016/j.trsl.2020.05.007 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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