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assign1 - Assignment#1 Clinical Trials(100 points Due 1(5...

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Assignment #1 Clinical Trials (100 points) Due February 10, 2011 1. (5) In clinical research studies it is important to control confounding factors in the design and/or analysis of the investigation. List 3 methods that are used to control/eliminate confounding. For each, give an example of a study that used the specific method. You can use examples from the class lectures. 2. (5) In a recently reported trial among patients with metastatic melanoma 676 patients were randomized in a 3:1:1 ratio to receive ipilimumab plus a gp100 peptide vaccine, ipilimumab plus placebo for gp100, or the gp100 vaccine plus placebo for ipilimumab. Assuming the randomization worked as planned, approximately how many patients would you expect there be in each treatment group? 3. (15) In a recent clinical trial of three mechanical heart valves, one valve (Edwards-Duromedics) was used on even operation days; one valve (Bjork-Shiley) was used on odd operation days when the patient's year of birth was an even one; the third valve (Medtronic-Hall) was used on odd operation days when the patient's year of birth was an odd one. a. (5) Did this study employ an appropriate method to assign treatments? Comment on “allocation concealment”. b. (5) What is the desired allocation ratio for this study based on the above description? c. (5) Describe how you would use simple randomization to generate treatment assignments for this study to obtain the desired allocation ratio. 4. (20) A study of 20 patients scheduled for orthopedic surgery are to be randomized to a surgical ointment (murpirocin) or placebo the day before surgery. The goal of this pilot study is to determine if murpirocin can eradicate Staphylococcus aureus nasal carriage prior to surgery.
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