P Platonov1. 1. Lund University, Lund, Sweden. Pyotr.Platonov@evidence-cpr.com
Abstract
OBJECTIVE: To review the current situation of clinical trials in Russia and Eastern Europe. FINDINGS: The volume of clinical trials in these territories is increasing. The quality of the data obtained, ethical care and compliance with Good Clinical Practice guidelines is at least as good as anywhere else. United States Food and Drug Administration inspection data indicate that sites in these countries are often superior to those elsewhere. Large-scale clinical trials conducted in these territories have been subsequently published in mainstream journals. Territory-specific attention must be paid to communications' equipment and language. However, this is countered, for example, by the fact that most clinical research associates in Russia hold degrees in medicine, that patients with previously untreated disease are more easily found than in North America or Western Europe, and the participation of large, purpose-built, healthcare institutions. CONCLUSION: Eastern Europe and Russia are well-established locales for clinical trials. These territories offer a solution to the competition for patients among clinical trials in North America or Western Europe.
OBJECTIVE: To review the current situation of clinical trials in Russia and Eastern Europe. FINDINGS: The volume of clinical trials in these territories is increasing. The quality of the data obtained, ethical care and compliance with Good Clinical Practice guidelines is at least as good as anywhere else. United States Food and Drug Administration inspection data indicate that sites in these countries are often superior to those elsewhere. Large-scale clinical trials conducted in these territories have been subsequently published in mainstream journals. Territory-specific attention must be paid to communications' equipment and language. However, this is countered, for example, by the fact that most clinical research associates in Russia hold degrees in medicine, that patients with previously untreated disease are more easily found than in North America or Western Europe, and the participation of large, purpose-built, healthcare institutions. CONCLUSION: Eastern Europe and Russia are well-established locales for clinical trials. These territories offer a solution to the competition for patients among clinical trials in North America or Western Europe.