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. Among these are:
- Treatment-naive populations
- Ease of patient recruiting
- Superb trial administration
- Lower costs
- Applicable EMEA standards or equivalents
- European Clinical Trial Site Options: 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.
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