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Trends in the globalization of clinical trials

Nature Reviews Drug Discovery volume 7, pages 13–14 (2008)Cite this article

Although these trends, and the associated regulatory, public health and economic implications, have been discussed qualitatively and extensively in the literature (for example, Refs 3,5,6,8), we are unaware of any recent Medline-indexed publications quantifying the globalization of biopharmaceutical clinical trials (BCTs; defined as trials assessing small-molecule pharmaceuticals and adjuvants, biologics and vaccines) based on publicly accessible data. This absence reflects in part historical difficulties in accessing comprehensive public data on the location of BCTs. However, owing to new mandates for clinical-trial registration from both the FDA and the International Committee of Medical Journal Editors9,10, there has recently been a substantial registration influx of ongoing and completed trials into ClinicalTrials.gov. As of January 2007, the site contains detailed descriptions of 36,249 recruiting and completed studies sponsored by the public and private sectors in more than 140 countries11.

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Figure 1: Density of actively recruiting clinical sites of biopharmaceutical clinical trials worldwide.

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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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Authors and Affiliations

  1. Fabio A. Thiers, Anthony J. Sinskey and Ernst R. Berndt are at the MIT Center for Biomedical Innovation, 77 Massachussetts Avenue, Cambridge, Massachusetts 02139, USA.,

    Fabio A. Thiers, Anthony J. Sinskey & Ernst R. Berndt

  2. A.J.S. and E.R.B. are also at the Harvard–MIT Division of Health Sciences and Technology., F.A.T.,

    Fabio A. Thiers, Anthony J. Sinskey & Ernst R. Berndt

  3. A.J.S. is also at the MIT Department of Biology.,

    Anthony J. Sinskey

  4. E.R.B. is also at the MIT Sloan School of Management.,

    Ernst R. Berndt

Authors
  1. Fabio A. Thiers
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  3. Ernst R. Berndt
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Corresponding author

Correspondence to Ernst R. Berndt.

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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