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.

Orphanet J Rare Dis · 2017 · PMC5335492 · PMID 28253932

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We also found that the fitted mean sample sizes for rare disease trials do differ slightly between prevalence classes (the interaction between prevalence and phase was close to significance) with slightly larger trials conducted in diseases with higher prevalence.

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