Andrzej Tomski https://orcid.org/0000-0001-6944-0600 , Barbara Gorzawska https://orcid.org/0000-0002-4263-8489

© Andrzej Tomski, Barbara Gorzawska. Article available under the CC BY-SA 4.0 licence

ARTICLE

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ABSTRACT

Sample size estimation is a necessary and crucial step in clinical trial research. Statistical requirements, limited patient availability and high financial risk of a clinical trial necessitate the proper calculation of this measure. The aim of this paper is to discuss the reasons why the estimation of the sample size is important and, based on the obtained results, to show how this process may be completed in selected cases. Stochastic simulations based on the Monte Carlo methods approach are applied. Therefore, new challenges facing this area of research are mentioned.

KEYWORDS

sample size, clinical trial, Monte Carlo methods, stochastic simulations

JEL

C13, C15, C18

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