Ethical and scientific implications of the globalization of clinical research

作者: Seth W. Glickman , John G. McHutchison , Eric D. Peterson , Charles B. Cairns , Robert A. Harrington

DOI: 10.1056/NEJMSB0803929

关键词:

摘要: In recent years, the number of clinical trials conducted in United States has declined, and majority study sites are now outside States, with marked growth research developing countries. The authors discuss implications globalization make recommendations about how to address challenges that have emerged.

参考文章(39)
Jean-Pierre Garnier, Rebuilding the R&D engine in big pharma. Harvard Business Review. ,vol. 86, pp. 68- 76 ,(2008)
SK Tate, DB Goldstein, SM Sisodiya, Pharmacogenetics goes genomic (vol 4, pg 937, 2003) Nature Reviews Genetics. ,(2004)
Jack Killen, Christine Grady, Gregory K. Folkers, Anthony S. Fauci, Ethics of clinical research in the developing world Nature Reviews Immunology. ,vol. 2, pp. 210- 215 ,(2002) , 10.1038/NRI745
Kevin A. Schulman, Damon M. Seils, Justin W. Timbie, Jeremy Sugarman, Lauren A. Dame, Kevin P. Weinfurt, Daniel B. Mark, Robert M. Califf, A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors The New England Journal of Medicine. ,vol. 347, pp. 1335- 1341 ,(2002) , 10.1056/NEJMSA020349
Dalu Zhang, Peng Yin, Nick Freemantle, Rachel Jordan, Nanshan Zhong, KK Cheng, An assessment of the quality of randomised controlled trials conducted in China Trials. ,vol. 9, pp. 22- 22 ,(2008) , 10.1186/1745-6215-9-22
Diane Gershon, From bench to bedside and back Nature. ,vol. 411, pp. 4- 5 ,(2001) , 10.1038/35108132
G J Annas, M A Grodin, Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal of Public Health. ,vol. 88, pp. 560- 563 ,(1998) , 10.2105/AJPH.88.4.560
David B. Goldstein, Sarah K. Tate, Sanjay M. Sisodiya, Pharmacogenetics goes genomic Nature Reviews Genetics. ,vol. 4, pp. 937- 947 ,(2003) , 10.1038/NRG1229
Michael E. Farkouh, George Dangas, Martin B. Leon, Craig Smith, Richard Nesto, John B. Buse, David J. Cohen, Elizabeth Mahoney, Lynn Sleeper, Spencer King, Michael Domanski, Sonja McKinlay, Valentin Fuster, Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial American Heart Journal. ,vol. 155, pp. 215- 223 ,(2008) , 10.1016/J.AHJ.2007.10.012
Jeffrey M. Drazen, Institutions, Contracts, and Academic Freedom New England Journal of Medicine. ,vol. 347, pp. 1362- 1363 ,(2002) , 10.1056/NEJME020122