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. 2010 Sep;126(3):e687-92.
doi: 10.1542/peds.2010-0098. Epub 2010 Aug 23.

Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity

Sara K Pasquali  1 , Danielle S Burstein, Daniel K Benjamin Jr, P Brian Smith, Jennifer S Li
Affiliations

Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity

Sara K Pasquali et al. Pediatrics. 2010 Sep.

Abstract

Objective: We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children.

Methods: Published studies containing the main results of trials conducted in 1998-2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported.

Results: Overall, 174 trials were included (sample size: 8-27 065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of trials that did report such information, 65% were conducted in >or=1 country outside the United States, and 11% did not include any sites in the United States. Fifty-four countries were represented, and 38% of trials enrolled patients in >or=1 site located in a developing/transition country, including more than one-third of infectious disease, cardiovascular, and allergy/immunology trials.

Conclusions: The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside the United States, and more than one-third of trials enrolled patients in developing/transition countries.

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Figures

Figure 1
Figure 1
Number of pediatric clinical trials with patients enrolled in at least one site in the region specified
See this image and copyright information in PMC

Comment in

  • Globalized pediatric research.
    Maldonado S, Berlin J, Siegel J, Waldstreicher J. Maldonado S, et al. Pediatrics. 2011 Jan;127(1):e251-2; author reply e253-4. doi: 10.1542/peds.2010-3381. Pediatrics. 2011. PMID: 21196575 No abstract available.
  • The globalization of pediatric trials: should we be worried?
    Dunne J, Murphy D, Wharton G. Dunne J, et al. Pediatrics. 2011 Jan;127(1):e252-3; author reply e253-4. doi: 10.1542/peds.2010-3381A. Pediatrics. 2011. PMID: 21196576 Free PMC article. No abstract available.

References

    1. Summary of the Annual Review of Developments in Globalization and Regional Integration in the Countries of the ESCWA Region by the United Nations Economic and Social Commission for Western Asia. [Accessed January 5, 2010]. Available at: http://www.escwa.un.org/information/publications/edit/upload/grid-02-2.pdf.
    1. Glickman SW, McHutchinson JG, Peterson ED, et al. Ethical and Scientific Implications of the Globalization of Clinical Research. N Engl J Med. 2009;360:816–23. - PubMed
    1. Li JS, Eisenstein EL, Grabowski HG, et al. Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program. JAMA. 2007;297:480–8. - PMC - PubMed
    1. The Pediatric Exclusivity Provision, January 2001 Status Report to Congress. [Accessed January 5, 2010]. Available at www.fda.gov/cder/pediatric.
    1. Best Pharmaceuticals for Children Act. [Accessed January 5, 2010]. Available at: www.fda.gov/cder/pediatric.

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