3_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

3_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

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The new england journal of medicine n engl j med 360;8 nejm.org february 19, 2009 818 ment in many wealthy countries. Regulations gov- erning the conduct of clinical research have be- come more and more complex, placing a greater burden on investigators in terms of compliance, documentation, and training. 17-20 In the United States, the costs of conducting clinical trials have generally outstripped federal funding for clinical research and strained industry’s site-level research budgets. 18 Although these regulations are well intended, they are generally uncoordinated and frequently have not been subjected to empirical study to determine which elements improve the conduct of trials and which elements add cost without benefiting participants or the research mission. 21-23 Ethical and Scientific Questions Raised by Globalization There are clear benefits to conducting trials in developing countries. These include fostering pos- itive relationships among clinician investigators globally and answering questions about the safe- ty and efficacy of drugs and devices that are of interest throughout the world. 20
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.

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