Clinical Trials in Central/Eastern Europe: Industry Viewpoint

Abstract

Over the past 15 years pharmaceutical companies and contract research organizations (CROs) have increased their presence in Central and Eastern Europe, and taken increasing advantage of the opportunities for conducting clinical trials there. Data from studies in these countries have been submitted by several Western European and American companies for marketing approval over the past five years and accepted by Western regulatory agencies and the Food and Drug Administration. Access to rare populations and a high prevalence of certain disorders puts countries of Central and Eastern Europe high on the priority list for clinical trials in some therapeutic areas. Additional numbers of patients are an asset where large populations are needed in multicenter Phase III studies. As enrollment is fast and compliance high, considerable time savings are achieved. There are, however, differences between running clinical trials in Western and Central/Eastern Europe and these will be considered.