The role of the unblinded sponsor statistician | Zendy

Snapinn Steven | Zendy; Cook Thomas | Zendy; Shapiro Deborah | Zendy; Snavely Duane | Zendy

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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.

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