By Al Doig
January 6, 2009 | As of early 2008, there were 50,629 clinical trials ongoing globally (Oppenheimer & Co.), up by 1.3% from 2007. While the United States still hosts the largest number of clinical trials, there are more than 150 other site countries around the globe. Growth in numbers of clinical trials conducted has led to increased competition among sponsor companies and CROs to find clinical sites and to recruit clinical investigators and treatment-naïve patient populations.
Europe offers a vast new opportunity for clinical trials as a result of the collapse of the Soviet Union. Dozens of sovereign countries have emerged, 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 Commonwealth of Independent States (CIS) to offer a spectrum of clinical trial options. A new publication from Insight Pharma Reports, European Clinical Trial Site Options: An Insider’s Analysis, provides a penetrating review and summation of opportunities for clinical trial programs in 44 countries, with contributions from 25 locally based, clinical trial specialists.
With the dramatic geopolitical shifts that have occurred over the past two decades, Europe now extends from Iceland in the West to the Ural Mountains in the East. The expansion of NATO and the desire for EU membership have been major drivers. This report organizes the countries within this enlarged geographical area into three groups: EU members, non-EU members, and CIS members.
The growth in EU Member States has carried with it the integration of EMEA regulations governing clinical trials, thus expanding the clinical trial options beyond the “cold war” countries of Western Europe. Countries such as Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia are EU Member States and were already hosting 2.5% of all global clinical trials recruiting patients at the end of 2007.
A second group of European countries have either decided against EU membership or have applied for and are awaiting EU community acceptance. These countries, either because of historical affiliations or applicant status requirements, have also integrated EMEA standards into their policies and regulations governing clinical trials. Among the countries in this category are Bosnia, Croatia, Serbia, Switzerland, and Turkey. Bosnia, Croatia, and Turkey were hosting 194 of all global clinical trials recruiting patients at the end of 2007.
The third group of countries consists of members of the CIS and includes Russia, Ukraine and Belarus, who together were hosting 393 of all global clinical trials recruiting patients at the end of 2007. These countries have been updating their policies and regulations governing clinical trials in order to attract clinical trial projects. Related to these efforts, an analysis within a report of FDA inspection outcomes of clinical trials conducted in these countries indicates that their performance is equivalent to—and in one case better than—their “Western” counterparts.
The countries covered in this report differ widely with regard to population size, distribution and quality of health care, forms of health care delivery, and availability of state-of-the-art facilities and trained investigators. However, in an increasingly competitive environment for patients and investigators, many of the countries of the New Europe offer attractive options.
Among these attractions are large, treatment-naïve patient populations eager to participate in trials in order to receive advanced treatment. In certain cases, the population density of these treatment-naïve patients is within acceptable travel distance to a country’s most prestigious university and medical school complex, where medical staff and administrators are eager to conduct clinical trials, and where costs are low.
What becomes clear from the report is how heterogeneous this landscape is on a number of dimensions. For example, even with the EMEA policies as a common denominator, most countries have layered their own sovereign view to aspects of the clinical trial process. This is best illustrated by the variations in clinical trial approval procedures and required documents described in the report for each country. These differences are likely to decrease as efforts at harmonization continue to evolve. However, what is encouraging from the report’s analysis is the degree to which the EMEA policies are the scaffold for clinical trial regulation across Europe.
Further Reading: European Clinical Trial Site Options: An Insider’s Analysis, by Pavle Vukojevic, MD. Published by Insight Pharma Reports, November 2008, www.InsightPharmaReports.com.