Healthy Skepticism Library item: 13746

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

Gilbert S.
Trials and tribulations.
Hastings Cent Rep 2008 Mar-Apr; 38:(2):14-8
http://www.thehastingscenter.org/publications/hcr/hcr.asp

Abstract:

This essay discusses issues concerning clinical research. The death of healthy subjects in clinical trials brings to fore previously ignored issues in clinical research. These include the pressure to enroll many human participants in clinical trials, conflicts of interest between researchers and sponsoring drug companies, and shortcomings in the oversight of clinical research by the federal government and ethical review boards. The American College of Physicians (ACP) and the U.S. Food and Drug Administration (FDA)are responding to these issues.

Keywords:
MeSH Terms: Academic Medical Centers Clinical Trials as Topic/ethics* Clinical Trials as Topic/standards Conflict of Interest* Drug Industry/ethics* Ethics Committees, Research/legislation & jurisprudence* Ethics, Clinical Ethics, Research* Federal Government Gene Therapy/ethics* Humans Patient Selection/ethics* Research Subjects United States United States Food and Drug Administration