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Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present.
Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the probability of rejecting the null hypothesis when the hypothesis is false.
A critical aspect of clinical trial design is determination of the sample size needed to establish the feasibility of the study. The number of participants should always be:
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