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Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from the aggregate analysis of clinicaltrials gov

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Fig. 1 Jittered boxplot of (class. Each symbol represents one observation and the mean sample size is indicated by the red diamond
Fig. 2 Fitted mean of sample size and 95% confidence interval back transformed from logarithmic values by class of prevalence and phase oftrial adjusted for interaction between prevalence, phase of study and the interaction between prevalence and phase, adjusted for gender, age,whether or not the trial had a DMC, whether or not the intervention was FDA regulated, intervention model, trial regions, number of countriesparticipating in the trial, year that enrolment to the protocol begins and number of arms
Table 1 Fitted mean of sample size and 95% confidence interval back transformed from logarithmic values, type III F statistic andthe corresponding p value of the effect of class of prevalence on sample size adjusting for phase and interaction betweenprevalence and phase, and without adjustment for other covariates and with adjustment for other covariatesa
Fig. 3 A breakdown of epidemiological data of rare diseases in Orphadata.of prevalence data entries per rare disease (extracted from literature); a Whether or not the rare disease has any prevalence data; b Number c Whether or not the given prevalence value is validated; d The subtype ofprevalence information by geographical area
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