SOCRA CCRP Practice Exam

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Which of the following factors is considered by statisticians when evaluating sample size for a clinical trial?

The experimental design
The publication date of protocol
The statistical significance level (alpha)
The variability of outcome

The correct answer is: The variability of outcome

Clinical trials require a significant amount of data to be collected in order to draw valid conclusions. That is why the variability of the outcome is an important factor to consider when determining sample size. A larger sample size is needed for studies with more variability in the outcome, compared to those with less variability. This is because a larger sample size allows for a more accurate representation of the population being studied. Option A, experimental design, may impact the type of analysis used in the study but not necessarily sample size. Option B, publication date of protocol, does not have any bearing on sample size. And option C, statistical significance level (alpha), is related to determining the level of confidence in the results, but it does not directly affect the sample size.