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The role of the unblinded sponsor statistician
Steven Snapinn1, Thomas Cook, Deborah Shapiro
1Merck Research Laboratories, BL3-2, West Point, PA 19486, USA. ssnapinn@amgen.com
Abstract:
In clinical trials sponsored by Merck the unblinded statistician is typically an employee of the company. From a pharmaceutical industry perspective, advantages of this approach include ensuring that the unblinded statistician is knowledgeable regarding the experimental treatments, therapeutic area and study objectives; that the quality of the analysis conforms to rigorous standards; and that the allocation schedule, database and interim results are kept confidential. These advantages are felt to outweigh any potential disadvantages.
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