Clinical trials in Russia: achieving excellence

Robert S. Reznik; Thomas E. Ichim; Vladimir Petrov; Boris N. Reznik

doi:10.1117/12.634618

22 June 2005 Clinical trials in Russia: achieving excellence

Robert S. Reznik, Thomas E. Ichim, Vladimir Petrov, Boris N. Reznik

Proceedings Volume 5771, Saratov Fall Meeting 2004: Optical Technologies in Biophysics and Medicine VI; (2005) https://doi.org/10.1117/12.634618
Event: Saratov, Russia, 2004, Saratov, Russian Federation

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.

Citation Download Citation

Robert S. Reznik, Thomas E. Ichim, Vladimir Petrov, and 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); https://doi.org/10.1117/12.634618

ACCESS THE FULL ARTICLE

INSTITUTIONAL
Select your institution to access the SPIE Digital Library.

SELECT YOUR INSTITUTION

PERSONAL
Sign in with your SPIE account to access your personal subscriptions or to use specific features such as save to my library, sign up for alerts, save searches, etc.

PERSONAL SIGN IN

No SPIE Account? Create one

PURCHASE THIS CONTENT

SUBSCRIBE TO DIGITAL LIBRARY

50 downloads per 1-year subscription

Members: $195

Non-members: $335 ADD TO CART

25 downloads per 1 - year subscription

Members: $145

Non-members: $250 ADD TO CART

PURCHASE SINGLE ARTICLE

Includes PDF, HTML & Video, when available