Advertisement

Clinical Trials in Central/Eastern Europe: Industry Viewpoint

  • Benona Lillian Natorff
Article

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 HI 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.

Key Words

Clinical trials Central/Eastern Europe 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Hughes G. Contract clinical research in Central and Eastern Europe. App Clin Trials. 1994;3(6):52–59.Google Scholar
  2. 2.
    Ward P. Conducting trials in Eastern Europe. App Clin Trials. 1995:45–48.Google Scholar

Copyright information

© Drug Information Association, Inc 1998

Authors and Affiliations

  • Benona Lillian Natorff
    • 1
  1. 1.Benona Lillian NatorffPharm-Olam International (UK) LtdBerkshireUK

Personalised recommendations