7_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

7_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 822 regulatory agencies around the world. The future of the pharmaceutical and device industries is predicated on addressing these issues. A compre- hensive review including representatives from de- veloped and developing countries, perhaps com- missioned by the Institute of Medicine or the World Health Organization, is needed to reach in- ternational consensus on these issues. We must ensure the ethical and scientific integrity of clin- ical research globally, promote harmonization of international research, and provide information about the benefits and risks of new drugs and devices in the populations and environments in which patients live, wherever they may be. The authors report receiving research grants, lecture fees, and consulting fees and having equity in several companies (see the Supplementary Appendix, available with the full text of this arti- cle at NEJM.org). No other potential conflict of interest relevant to this article was reported. We thank Lisa Berdan at Duke University for commenting on a previous draft of the manuscript, Alice Fortune-Greeley and Samantha Phillips at Duke University for research assistance, and Damon Seils at Duke University for research assistance and assistance with manuscript preparation. From the Duke Clinical Research Institute, Duke Translational Medicine Institute (S.W.G., J.G.M., E.D.P., C.B.C., R.A.H., R.M.C., K.A.S.), and the Department of Medicine (J.G.M., E.D.P., R.A.H., R.M.C., K.A.S.), Duke University School of Med- icine, Durham, NC; and the Department of Emergency Medi- cine, University of North Carolina School of Medicine, Chapel Hill (S.W.G., C.B.C.). Address reprint requests to Dr. Schulman at the Center for Clinical and Genetic Economics, Duke Clinical
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