Length 
250 pages

Date published 
December 2008

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

 

coverConducting Clinical Trials in Europe: An Insider’s Analysis

Author: Pavle Vukojevic, MD

 

 


 

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
 


Figure 

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
Dr. Pavle Vukojevic is currently the Vice President, Medical Affairs, for Pharm-Olam International. After graduating from Medical School and completing his Residency, he worked at the Institute of Rheumatology in Belgrade as a Junior Clinical Doctor. He finished his postgraduate studies in Immunology and took a specialization in Internal Medicine (1996) and continued to work as a Senior Doctor/Consultant in the Institute and as a teaching assistant for Internal Medicine/ Rheumatology at the Medical Faculty, University of Belgrade (1998). In 1997, he started to work in a part-time capacity for Pharm-Olam International as a Clinical Research Associate. In November 2001, Pavle became a full-time CRA and, in February 2002, was appointed to the position of Medical Director of the newly opened Pharm-Olam Int. Representative Office in Serbia and Montenegro. From 2003, he was acting as Regional Director of Operations for Pharm-Olam International, coordinating operations, recruitment, and practical training of all new CRAs in neighboring countries. In 2005, Pavle was appointed to Global Medical Director for Pharm-Olam. He is also the founder of ACRP in Serbia and was Chapter President until the end of 2007. Dr Vukojevic can be contacted at the following. Omladiinskih Brigada 88b (Airport City), 11070 Belgrade, Serbia & Montenegro, Tel: + 381 11 353 87 00  Ext 38138 e-mail pavle.vukojevic@pharm-olam.com