The Current Climate of Clinical Trials in Russia and Ukraine | Page 2

INTRODUCTION Background Although clinical trials, both domestic and multinational, have been conducted in Russia and Ukraine for many years, there is increasing interest in conducting multinational trials for a number of reasons. As European borders have opened and standardized guidelines and processes have been or are being established, it is becoming easier than ever before to access populations in these countries. Despite a smaller overall population (~43 million people4), there is similar access to potential participants who are treatment naïve in Ukraine, with 69.5% of people living in urban areas.5-7 In this paper, we discuss the current health-care and clinical-trial environments for Russia and Ukraine. Recently expressed concerns in these countries are acknowledged, and important considerations when applying for clinical trial approval are discussed, based on locally based experience. With a population of ~144 million people,1,2 of which 73.9% live in urban areas,2,3 Russia in particular provides a promising pool of potential, often treatment-naïve participants for clinical trials. P OPULAT ION PY RAMID I N RU S S I A I N 2 0 1 4 ( M E N VS . WO M E N) 100+ 95-99 90-94 85-89 80-84 75-79 70-74 65-69 60-64 55-59 50-54 45-49 40-44 35-39 30-34 25-29 20-24 15-19 10-14 5-9 0-4 7 5.6 4.2 Population (in Millions) 2.8 1.4 0 0 Age Group 1.4 2.8 4.2 5.6 7 Population (in Millions) 2 Figure 1. Population Pyramid in Russia in 2014 Source: World Factbook: Russia; https://www.cia.gov/library/publications/the-world-factbook/geos/rs.html