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References
Rettig, R. A. The industrialization of clinical research. Health Aff. (Millwood). 19, 129–146 (2000).
Olliaro, P. L. et al. Drug studies in developing countries. Bull. World Health Organ. 79, 894–895 (2001).
Shah S. Globalization of clinical research by the pharmaceutical industry. Int. J. Health Serv. 33, 29–36 (2003).
Getz K. A. CRO contribution to drug development is substantial and growing globally. Impact Report 8, 1–4 (2006).
Rehnquist J. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Office of Inspector General Department of Health and Human Services web site [online], (2001).
Goldbrunner, T., Doz, Y. Wilson, K. & Veldhoen, S. The Well-Designed Global R&D Network. Strategy + Business web site [online], (2006).
International Conference on Harmonization (ICH). E6(R1). Good Clinical Practice: Consolidated Guideline. ICH web site [online], (1996).
International Conference on Harmonization (ICH). E5(R1). Ethnic factors in the Acceptability of Foreign Clinical Data. ICH web site http://www.ich.org/cache/compo/475-272-1.html[online], (1998).
Food and Drug Administration (FDA). Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov. FDA web site [online], (2007).
De Angelis, C. D et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Lancet 365, 1827–1829 (2005).
Zarin, D. A. et al. Issues in the registration of clinical trials. JAMA 297, 2112–2120 (2007).
Jia, H. China beckons to clinical trial sponsors. Nature Biotech. 23, 768 (2005).
Acknowledgements
We thank F. L. Douglas and H. Golub of the Harvard–MIT Division of Health Sciences and Technology, and M. S. Trusheim, MIT Sloan School, for comments on early drafts. Funding: MIT's Hugh Hampton Young Memorial Fellowship (F.A.T); Louis E. Seley Chaired Professorship (E.R.B).Preliminary results described in Science Master Thesis (F.A.T) entitled: The Globalization of Clinical Drug Development, submitted to the Harvard–MIT Division of Health Sciences and Technology.
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Supplementary information
Supplementary information S1 (box)
Methodology of analysis. (PDF 105 kb)
Supplementary information S2 (box)
Recent evolution of regional shares of biopharmaceutical clinical trial sites. (PDF 140 kb)
Supplementary information S3 (table)
Top 50 countries Ranked by number of trial Sites – shares and trial capacity. (PDF 468 kb)
Supplementary information S4 (table)
Top 50 countries ranked by average relative annual growth rates. (PDF 510 kb)
Supplementary information S5 (table)
Types of trial by region as of April 12, 2008 (in percent) (PDF 130 kb)
Supplementary information S6 (table)
Regional distribution of trial type as of April 12, 2007 (in percent) (PDF 107 kb)
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Thiers, F., Sinskey, A. & Berndt, E. Trends in the globalization of clinical trials. Nat Rev Drug Discov 7, 13–14 (2008). https://doi.org/10.1038/nrd2441
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DOI: https://doi.org/10.1038/nrd2441
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