assign4 - Assignment #4 Clinical Trials (100 points) Due...

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Clinical Trials (100 points) Due April 21, 2011 1. (50) A clinical trial to compare a cholesterol-lowering drug with placebo among individuals with coronary disease or other occlusive disease, but with below average levels of LDL cholesterol (the "bad" cholesterol) is planned. The investigators hypothesize that further lowering of cholesterol in this high risk group is beneficial. The primary endpoint is total mortality and the planned follow-up is 5 years. It is expected that 10% of participants given placebo will die in 5 years. The cholesterol lowering treatment is estimated to lower the LDL cholesterol level by 40 mg/dl more than placebo. The full effect of this cholesterol lowering treatment is assumed to result in 20% fewer deaths than the placebo group. It is assumed that the full effect of the treatment on mortality will not be reached for 2 1/2 years. It is also assumed that the non-adherence rate to the capsules prescribed will be 30% in the group that receive the cholesterol-lowering drug by the end of the 5-year trial. a. (5) Using Halperin's model and Table 1 in his paper, what is the adjusted value for p e ? b. (5) What is the combined sample size required for this study based on your estimate of p e in part a. See 1 st formula on slide #7 of Lecture 17). Assume the type I error is 0.05 (2-sided) and power = 0.90. c. (5) If there was no lag, what would the adjusted value of p e be (assume the non-adherence rate to the capsules for the cholesterol-lowering drug is 30% as in part a.)? d. (5) If compliance was perfect (100%) in the cholesterol-lowering group, what would the adjusted value of p e be if the lag was 2 1/2 years? e. (5) Would sample size be larger or smaller than the estimate in part b. if compliance to the cholesterol lowering treatment was 100% (zero dropouts in Halperin’s terminology)? f. (5) What would be the impact on sample size (larger or smaller than your answer in part b.) for this study if the estimated death rate was 7.5% for the placebo group instead of 10% (assume all other assumptions in the study description above are the same)? g. (5) The investigators predict that 15% of patients assigned placebo will begin taking a cholesterol lowering treatment during follow-up. If this is taken into account in the determination of sample size, what impact would it have (just state larger, smaller, or no change in sample size estimated for part b.)? 1
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assign4 - Assignment #4 Clinical Trials (100 points) Due...

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