22 June 2005 Clinical trials in Russia: achieving excellence
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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.
© (2005) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Robert S. Reznik, Robert S. Reznik, Thomas E. Ichim, Thomas E. Ichim, Vladimir Petrov, Vladimir Petrov, Boris N. Reznik, Boris N. Reznik, } "Clinical trials in Russia: achieving excellence", Proc. SPIE 5771, Saratov Fall Meeting 2004: Optical Technologies in Biophysics and Medicine VI, (22 June 2005); doi: 10.1117/12.634618; https://doi.org/10.1117/12.634618


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