Clinical trails -Essay

1. Read the ICH E10 (have been uploaded) guideline on choice o control group in clinical trials.

(a) Describe the ethical issues in placebo control control trails and explain how they might be overcome by design modifications.

(b)Describe methodological issues in active-control trials and outline how they might be overcome.
Use an absolute maximum of 600 words for each of parts 1(a) and 1(b).

2. Previous studies of Vinpocetine (an extract from the periwinkle plant) suggest that it improves the memory by increasing the blood flow in the brain. A neurologist suspects that the increased blood flow might also affect the IQ (as measured by the Wechsler Adult Intelligence Scale) by fostering cortical re-mapping. You have been approached to help design a Phase III clinical study to evaluate the hypothesis that 10mg of Vinpocetine daily increases the IQ by at least 10 points.

(a) Describe in detail how the study should be undertaken.
(b) Derive the necessary sample size for your study. You may assume that IQ measurements are normally distributed with a standard deviation of 15. The mean IQ without intervention is 100, a two-sided type-I-error of 10% should be used and the power should be at least 80%.

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