Conducting Clinical Trials in Europe: An Insider's Analysis Overview

Abstract

A vast new opportunity for clinical trials has emerged in Europe as a result of the collapse of the Soviet Union and events during the last decade of the 20th century. The result is the emergence of dozens of sovereign countries and gone is the political dividing line between East and West Europe. Now these countries join the countries of Western Europe as well as the CIS to offer a spectrum of clinical trial options.

• Treatment-naive populations
• Ease of patient recruiting
• Superb trial administration
• Lower costs
• Applicable EMEA standards or equivalents

Conducting Clinical Trials in Europe: An Insider' s Analysis, authored by a CRO executive living in Serbia, provides a penetrating review and summation on the state of and opportunities for clinical trial programs in 44 countries organized into three categories.

• EU Member States and applicants
• Non EU affiliated states
• Membership of the CIS

A standardized template is employed to summarize the salient aspects for each country.

• Geographic and population information
• Recent political history and religious demographics
• Type of healthcare system, its funding and distribution
• Regulatory structure governing clinical trials
• Policies, procedures, timelines and fee structures for single and multi-site clinical trial applications
• Past clinical trial history and FDA inspection data if available
• Quality of medical staff training, English proficiency, and clinical interest
• Plus - “insider” comments on the pros and cons to expect

The clinical trials industry in the developed countries in Europe is a mature and expensive option. Most of these populations are treatment savvy and due to competition patient recruiting can be difficult and time consuming. These considerations have driven companies to consider India and China as sites for clinical trials. However, differences in medical practices and training as well as problems with English language fluency can become extremely problematic. The current definition of Europe, all territory west of the Urals, has opened the opportunities for clinical trials.