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Abstract:
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Due to the small number of patients affected by some rare infectious diseases, clinical trials studying these diseases are either underpowered because of the difficulty of recruiting adequate numbers of subjects, or the study recruiting period is prolonged, resulting in great expense. An appropriately designed trial is imperative. Currently, however, the methodologies for studying rare infectious diseases are not significantly different from the methodologies for studying other diseases. In this research, we provide a review of the methodologies for studying rare infectious diseases with comparisons of the statistical properties. We provide an example of designing a rare infection trial with both frequentist and Bayesian approaches. The sample size and power under each approach are presented.
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