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- W2999080916 abstract "The sample size computation methodology for Phase III, confirmatory, trials is discussed in relation to the probability of success. It is shown that when experimental planning is based on the to a clinically relevant effect: a) the aim of Phase III trials, that is proving clinical relevance, is not accounted for; b) the actual probability of proving clinical relevance is about 41%.Therefore, sample size computations based on the power to detect is logically wrong and not ethically sound. The sample size for Phase III trials should be computed on the basis of a likely value of the unknown parameter under testing, and not on a value which is scientifically relevant. Instead, the latter should be embedded in the hypotheses under testing, leading to the so-called power to prove. Examples from the literature showing errors committed when the power to detect is adopted are reported and discussed. A realistic simulation comparing power to detect and power to prove reports their pros and cons in practice. Then, power to detect and power to prove are evaluated in relation with ICH9. Finally, results are discussed considering recent literature." @default.
- W2999080916 created "2020-01-23" @default.
- W2999080916 creator A5074335131 @default.
- W2999080916 date "2019-01-01" @default.
- W2999080916 modified "2023-09-27" @default.
- W2999080916 title "Phase III Sample Size Based on the 'Power to Detect' Is Logically Wrong and Usually Unethical" @default.
- W2999080916 doi "https://doi.org/10.2139/ssrn.3328810" @default.
- W2999080916 hasPublicationYear "2019" @default.
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