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BioPortfolio | Insight Pharma Reports | Conducting Clinical Trials in Europe: An Insider’s Analysis

Conducting Clinical Trials in Europe: An Insider’s Analysis

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. Among these are:

Treatment-naïve 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. The information includes:

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.

About the Author

Pavle Vukojevic, MD, is Vice President, Medical Affairs for Pharm-Olam International. He received his MD degree from Belgrade University and served as a consulting rheumatologist in Belgrade for over 10 years. Dr. Vukojevic has been involved in clinical research trials for over 15 years and has experience in all phases and with many indications. In 2001, he joined Pharm-Olam and has been involved in setting up the Pharm-Olam Int. Representative Office in Serbia and Montenegro. As the Regional Director of Operations for Pharm-Olam International, he coordinates operations, recruitment, and practical training for all new CRAs in neighboring countries. Dr. Vukojevic founded ACRP in Serbia and was chapter president until recently.

December 2008 Pages 250
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