Question

Your boss asks you to plan the sample size for a randomized, double-blind, controlled trial in the clinical development of a cure for irritable bowl disease. Current standard treatment shall be compared with a new treatment in this trial. The S3-guideline of AWM demonstrated a mean change of the summary score of the validated health related quality of life questionnaire at 8 weeks of 16 with standard deviation 23 under standard treatment. You quote the drop-out rate of 11% from literature (previous phase of clinical development). Your research yielded a clinically important effect of 4 that has been found to be the Minimal Clinically Important Difference (MCID). In order to demonstrate superiority of the new treatment over standard of care, you assume that the change in of the summary score of the validated health related quality of life questionnaire follows a normal distribution, and that the standard deviation is the same for both treatments. How many patientes would one need to recruit for the trial to demonstrate the clinically interesting difference between treatments at significance level 5% with 95% power?

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Answer to a math question Your boss asks you to plan the sample size for a randomized, double-blind, controlled trial in the clinical development of a cure for irritable bowl disease. Current standard treatment shall be compared with a new treatment in this trial. The S3-guideline of AWM demonstrated a mean change of the summary score of the validated health related quality of life questionnaire at 8 weeks of 16 with standard deviation 23 under standard treatment. You quote the drop-out rate of 11% from literature (previous phase of clinical development). Your research yielded a clinically important effect of 4 that has been found to be the Minimal Clinically Important Difference (MCID). In order to demonstrate superiority of the new treatment over standard of care, you assume that the change in of the summary score of the validated health related quality of life questionnaire follows a normal distribution, and that the standard deviation is the same for both treatments. How many patientes would one need to recruit for the trial to demonstrate the clinically interesting difference between treatments at significance level 5% with 95% power?

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100 Answers

\frac{2\times\left(1.96+1.645\right)^2\times23^2}{4^2}=859.36 Therefore sample size is 860

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