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Hypothesis testing is a fundamental statistical tool that begins with the assumption that the null hypothesis H0 is true. During this process, two types of errors can occur: Type I and Type II. A Type I error refers to the incorrect rejection of a true null hypothesis, while a Type II error involves the failure to reject a false null hypothesis.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Comments on 'Two-sample binary phase 2 trials with low type I error and low sample size'

Guogen Shan1

  • 1Epidemiology and Biostatistics Program, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, 89154, NV, U.S.A.

Statistics in Medicine
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PubMed
Summary

No abstract available in PubMed .

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