Statistical consideration in the design of COVID-19 clinical trials in emergency
10.12092/j.issn.1009-2501.2020.02.001
- VernacularTitle: 新冠肺炎应急临床试验设计中的统计学考虑
- Author:
Yi LUO
1
Author Information
1. Beijing KeyTech Statistical Consulting Co., Ltd
- Publication Type:Journal Article
- Keywords:
Clinical endpoint;
Coronavirus disease 2019;
Interim analysis;
Sample size;
Single arm design
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(2):121-125
- CountryChina
- Language:Chinese
-
Abstract:
The outbreak of coronavirus disease 2019 (COVID-19) led to the first-level response to major public health emergencies in China. To explore the therapy of COVID-19, hundreds of clinical studies were conducted. For major public health emergencies, it is important to find out the effective drug and therapeutic regimen as soon as possible for the control of disease, which raises the claim of timeliness to the trials conducted in emergency, especially to the registered clinical trials. This paper discusses the choice of clinical endpoint and related questions in the design of clinical trials in emergency from the statistical perspective.
