Healthy Skepticism Library item: 1795

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Snapinn S, Cook T, Shapiro D, Snavely D.
The role of the unblinded sponsor statistician.
Stat Med 2004 May 30; 23:(10):1531-3
http://www3.interscience.wiley.com/cgi-bin/abstract/108561305/ABSTRACT

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. Copyright 2004 John Wiley & Sons, Ltd.

Keywords:
Clinical Trials/ethics* Clinical Trials/standards Clinical Trials Data Monitoring Committees/ethics* Clinical Trials Data Monitoring Committees/trends Drug Industry/ethics* Drug Industry/standards Ethics, Professional Female Humans Male Statistics/ethics* Statistics/standards