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The role of the unblinded sponsor statistician
Author(s) -
Snapinn Steven,
Cook Thomas,
Shapiro Deborah,
Snavely Duane
Publication year - 2004
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1790
Subject(s) - statistician , computer science , medline , econometrics , statistics , mathematics , political science , law
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. Copyright © 2004 John Wiley & Sons, Ltd.