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Sample size in clinical trials – challenges and approaches

100%
Tomski A., Gorzawska B.
Przegląd Statystyczny
|
2022
|
vol. 69
|
issue 4
20-28
EN
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.
2

Etyczne aspekty prowadzenia badań klinicznych na tle regulacji karnomaterialnych

63%
Piech K.
Studenckie Prace Prawnicze, Administratywistyczne i Ekonomiczne
|
2019
|
vol. 27
73-89
EN
The article discusses the issue of rules of conducting clinical trials, both in criminal and ethical terms. The author presents successively the principles of conducting medical experiments, including research on medicinal products with the participation of people, especially focusing on the issue of risk that threatens the patient. Next, the ethical principles of conducting clinical trials, classified by international rank acts, are described. The author compares the content of two groups of norms, striving to answer the question of whether it is possible that such a state of affairs exists, in which a clinical trial would be legally accepted, but would not be characterized by the attribute of ethics.
3
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COVID-19 – czas na wnioski. Czy szczepienia są eksperymentem medycznym?

63%
Wieczorek A.
MAZOWSZE Studia Regionalne
|
2022
|
issue 43
95-104
EN
The aim of the article is: to familiarise readers with selected legal aspects of medical experiments and clinical trials; to make decision-makers aware that COVID-19 vaccination creates the impression of a medical experiment.
PL
Celem artykuł jest: przybliżenie czytelnikom wybranych aspektów prawnych dotyczących eksperymentów medycznych i badań klinicznych; uświadomienie decydentom, że szczepienia przeciw COVID-19 stwarzają wrażenie eksperymentu medycznego.
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