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

BACKGROUND: Clinical trials are typically designed using the classical frequentist framework to constrain type I and II error rates. Sample sizes required in such designs typically range from hundreds to thousands of patients which can be challenging for rare diseases. It has been shown that rare di...

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Detalhes bibliográficos
Publicado no:Orphanet J Rare Dis
Main Authors: Hee, Siew Wan, Willis, Adrian, Tudur Smith, Catrin, Day, Simon, Miller, Frank, Madan, Jason, Posch, Martin, Zohar, Sarah, Stallard, Nigel
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2017
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5335492/
https://ncbi.nlm.nih.gov/pubmed/28253932
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-017-0597-1
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