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Proceedings Paper

Clinical trials in Russia: achieving excellence
Author(s): Robert S. Reznik; Thomas E. Ichim; Vladimir Petrov; Boris N. Reznik
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Paper Abstract

The Russian population offers a unique opportunity for conducting clinical trials in general, and specifically in the area of Medical Devices. Although the regulatory framework for approval of clinical trials and eventual marketing registration is based on an American-style format, details of operating in the Russian framework are very different. Understanding and leveraging the unique characteristics of the Russian system on the patient side, the investigator side, and the regulatory side is important in extracting optimum value out of clinical trials in Russia. Having performed Medical Device research and clinical trials in Russia, the authors overview the present system and describe various strategies for working in this growing but still under-utilized clinical trials arena.

Paper Details

Date Published: 22 June 2005
PDF: 6 pages
Proc. SPIE 5771, Saratov Fall Meeting 2004: Optical Technologies in Biophysics and Medicine VI, (22 June 2005); doi: 10.1117/12.634618
Show Author Affiliations
Robert S. Reznik, Vita Clinical Research (United States)
Thomas E. Ichim, BioRASI LLC (United States)
Vladimir Petrov, Advanced BioSciences Research (Russia)
Boris N. Reznik, BioRASI LLC (United States)

Published in SPIE Proceedings Vol. 5771:
Saratov Fall Meeting 2004: Optical Technologies in Biophysics and Medicine VI
Valery V. Tuchin, Editor(s)

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