Author: gao song; meng qun cheng; xian wen wei
Title: Advance of Novel Coronavirus Registration Clinical Trial Document date: 2020_3_20
ID: fk2wc715_39
Snippet: The design of COVID-19 clinical trials should give priority to "timeliness". The trial sample size needs to consider the balance between clinical and statistical significance, and its estimated volume reflects the reliability and repeatability of the research results [18] .As public health emergencies do not allow more time for exploratory clinical research and there is no historical data, the sample size estimation of such trials may encounter u.....
Document: The design of COVID-19 clinical trials should give priority to "timeliness". The trial sample size needs to consider the balance between clinical and statistical significance, and its estimated volume reflects the reliability and repeatability of the research results [18] .As public health emergencies do not allow more time for exploratory clinical research and there is no historical data, the sample size estimation of such trials may encounter unprecedented problems.Some scholars have proposed [19] , whether it is possible to reduce the required sample size by "reducing the power" or "increasing the type I error rate" to complete the clinical trial as soon as possible?But such an approach requires a variety of trade-offs between regulators, sponsors, and researchers.
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