Healthy Skepticism Library item: 2401

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

Lachin JM.
Conflicts of interest in data monitoring of industry versus publicly financed clinical trials.
Stat Med 2004 May 30; 23:(10):1519-21
http://www3.interscience.wiley.com/cgi-bin/abstract/108561304/ABSTRACT

Abstract:

The FDA Guidance, while highly appropriate for industry sponsored trials, need not be imposed on publicly (e.g. NIH) financed clinical trials. While the potential for conflicts of interest exist in the latter, they are in general manageable and pose an acceptable low risk of threatening the integrity of a study. However, the Guidance should heighten the awareness of all investigators in public trials to the potential for the appearance of conflicts and to the need for full and open participation in the management of dualities of interest. Copyright 2004 John Wiley & Sons, Ltd.

Keywords:
MeSH Terms: Clinical Trials/economics Clinical Trials/ethics* Clinical Trials/standards Clinical Trials Data Monitoring Committees/ethics* Clinical Trials Data Monitoring Committees/standards Conflict of Interest* Data Interpretation, Statistical Drug Industry/economics Drug Industry/ethics* Drug Industry/standards Ethics, Professional Financing, Government Guidelines Humans National Institutes of Health (U.S.)/ethics* National Institutes of Health (U.S.)/standards Statistics/ethics* United States United States Food and Drug Administration/ethics* United States Food and Drug Administration/standards