3_Ethical Variability - Petryna

3_Ethical Variability - Petryna - Globalizing clinical...

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global testing of pharmaceuticals and provides the means through which pharmaceutical sponsors and their third- party CROs achieve recruitment successes. More human subjects What drives the demand for larger pools of human sub- jects? First, it is the sheer number of trials being run. One market research company estimates that as of 2000, there were about 7,500 new clinical projects being designed for research and development worldwide. By 2001, that number had purportedly grown to 10,000 (Brescia 2002). 6 Second, to satisfy U.S. regulatory demands, increasingly large numbers of patients must be included in clinical trials to prove products’ long-term safety, especially for drugs intended to be widely prescribed. Third, some ther- apeutic categories—such as hypertension—are being over- whelmed with new drugs. Competition to get these drugs approved and to bring them to market intensifies the search for subjects. Fourth, there is a ‘‘drug pipeline explosion’’—patent applications are flooding the U.S. Patent Office for new compounds that have yet to be clinically tested. Shifts in the very science of drug development also influence the decision to increase subject recruitment. As a vast amount of potential molecular therapeutics is gen- erated, making right decisions regarding which molecules to test becomes more difficult. Consider Genasense, a technology made up of genetic snippets that pass through cells and block the expression of some harmful proteins.
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3_Ethical Variability - Petryna - Globalizing clinical...

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