5_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

5_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 820 In another study, a common mitochondrial poly- morphism associated with impaired ethanol me- tabolism and decreased efficacy of nitroglycerin treatment 53 was found almost exclusively in popu- lations of Asian origin, including 40% of persons of East Asian origin. 54 This finding may affect the relevance of trials involving cardiac, circulatory, and neurologic disorders that are treated with nitroglycerin or nitric oxide–dependent therapies. 55 Genetic diversity is often not considered in study design and interpretation and in the reporting of trial results. Next Steps In our opinion, multiple approaches are needed to address concerns raised by the globalization of clinical research (Table 2). In general, the goal is to foster innovation and access to therapies while ensuring that clinical research is conducted in populations in proportion to the potential uses of the products after approval. Also, it is essen- tial to create a robust framework to ensure the integrity of research, wherever it takes place. The complexity and cost of clinical research in developed countries are recurring concerns. A careful effort to streamline regulations govern-
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