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# assign3 - Assignment#3 Clinical Trials(100 points Due April...

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Assignment #3 Clinical Trials (100 points) Due April 5, 2011 1. (20) The following data were obtained from a randomized, double-blind crossover clinical trial involving participants with mild to acute bronchial asthma. The treatments were single doses of two active drugs (A and B). The response is forced expiratory volume in one second (FEV1). Treatment Participant Sequence Baseline Period 1 Washout Period 2 1 AB 1.09 1.28 1.24 1.33 2 BA 1.74 3.06 1.54 1.38 3 AB 1.38 1.60 1.90 2.21 4 BA 2.41 2.68 2.13 2.10 5 AB 2.27 2.46 2.19 2.43 6 BA 3.05 2.60 2.18 2.32 7 AB 1.34 1.41 1.47 1.81 8 BA 1.20 1.48 1.41 1.30 9 AB 1.31 1.40 0.85 0.85 10 BA 1.70 2.08 2.21 2.34 11 AB 0.96 1.12 1.12 1.20 12 BA 1.89 2.72 2.05 2.48 13 AB 0.66 0.90 0.78 0.90 14 BA 0.89 1.94 0.72 1.11 15 AB 1.69 2.41 1.90 2.79 16 BA 2.41 3.35 2.83 3.23 17 BA 0.96 1.16 1.01 1.25 a. (5) Using the period 1 and 2 measurements, determine the difference between treatments A and B in FEV1 and its 95% CI. b. (5) Use the period 1 and period 2 measurements to determine if there is evidence of differential carry over effects? (Construct the appropriate test statistic and test the hypothesis that the carry over effects are equal. Show your work.) c. (5) Using the period 1 and 2 measurements, determine if there is period effect. Compute the test statistic and the corresponding p-value. d. (5) Construct a test statistic using the baseline and washout levels of FEV1 to test the hypothesis that the residual effect of the treatments used in Period 1 are different. 1

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2. (15) A study is being planned to assess the influence of sodium intake on blood pressure. Men and women with above average levels of blood pressure, who meet other eligibility criteria and who consent to participate in the study will be enrolled in a 12 week intensive dietary intervention program to reduce dietary sodium intake. After 12 weeks of intervention, patients who excrete 25 meq/8 hours (overnight) or less of sodium in the urine will be given 1 of 3 treatments: 1) placebo, 2) 50 meq sodium, or 3) 100 meq sodium. Based on another study, the average overnight sodium excretion after 12 weeks of dietary intervention is estimated as 45 meq/8 hours. (This is the estimated average sodium excretion prior to randomization). The between subject variability for overnight sodium excretion is estimated as 225 (meq/8 hours) 2 . The intra-subject variability is estimated as 625 (meq/8 hours)
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assign3 - Assignment#3 Clinical Trials(100 points Due April...

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