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Review
. 2012 Feb 15;313(1-2):1-6.
doi: 10.1016/j.jns.2011.10.004. Epub 2011 Nov 1.

Implementing clinical trials on an international platform: challenges and perspectives

Affiliations
Review

Implementing clinical trials on an international platform: challenges and perspectives

Greg Minisman et al. J Neurol Sci. .

Abstract

The importance of conducting medical research on a global or international platform cannot be overemphasized in current times. Sponsors are encouraging international clinical trials for a number of reasons. Globally, clinical trials are under increasing pressure to meet patient recruitment goals quickly and efficiently, at times with very limited resources. Conducting clinical trials in multiple countries increases access to potentially eligible study subjects. It is reasonable to believe that international trials will be completed more quickly and efficiently, leading to more rapid advancement in science and conservation of research-specific resources. Rapid advancement in science can reduce the burden of disease, promote health, and extend longevity for all people. In addition, generalizability, one of the major goals of translational medicine, will increase when recruiting patients from multiple countries and multiple ethnicities. Further, improvement of global health may be possible when certain types of clinical trials are conducted in countries that would not otherwise have access to an innovative drug or intervention.

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References

    1. Aban IB, Wolfe GI, Cutter G, Kaminski H, Jaretzki A, III, Minisman G, Conwit R, Newsom-Davis J. The MGTX experience: challenges in planning and executing an international, multicenter clinical trial. Journal of Neuroimmunology. 2009;217(1–2):103. (Erratum: Journal of Neuroimmunol. 201–202(2008)80–84) - PMC - PubMed
    1. Neaton J, Babiker A, Bohnhorst M, Darbyshire J, Denning E, Frishman A, Grarup J, Larson G, Lundgren J. Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by National Institute of health. Clinical Trials. 2010;7:705–718. - PMC - PubMed
    1. Bollyky T, Cockburn I, Berndt E. Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases. Clinical Trials. 2010;7:719–734. - PubMed
    1. Yusuf S. Damage to important clinical trials by over-regulation. Clinical Trials. 2010;7:622–625. - PubMed
    1. Bilbault P, Belorgey C, Zannad F, Golinelli D, Pletan Y participants of Round Table n°4 of Giens XXV. Clinical Trials Legislation - preparing for the revision of the European Directive Scheduled for 2011. Therapie. 2010 Jul–Aug;65(4):301–8. 291–9. - PubMed

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