14. A clinical trial is being planned to investigate the effect of a new experim

Question

14. A clinical trial is being planned to investigate the effect of a new experimental drug designed to reduce total serum cholesterol. Investigators will enroll participants with total cholesterol levels between 200-240, they will be randomized to receive the new drug or a placebo and followed for 2 months, and the total cholesterol will be measured. Investigators plan to run a test of hypothesis and want 80% power to detect a difference of 10 points in mean total cholesterol levels between groups. They assume that 10% of the participants randomized will be lost over the 2 month follow-up. How many participants must be enrolled in the study? Assume that the standard deviation of total cholesterol is 18.5.

Explanation / Answer

14. A clinical trial is being planned to investigate the effect of a new experimental drug designed to reduce total serum cholesterol. Investigators will enroll participants with total cholesterol levels between 200-240, they will be randomized to receive the new drug or a placebo and followed for 2 months, and the total cholesterol will be measured. Investigators plan to run a test of hypothesis and want 80% power to detect a difference of 10 points in mean total cholesterol levels between groups. They assume that 10% of the participants randomized will be lost over the 2 month follow-up. How many participants must be enrolled in the study? Assume that the standard deviation of total cholesterol is 18.5.

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