The Baltic States: A Location for Your Next Clinical Trial

The Baltic States with its appropriate population size, sufficient infrastructure, and experienced and motivated investigators, make it an attractive choice for a clinical trial.

In this article, Doatas Grina, Indre Tutlyte and Auudius Sveikata, PhD, that ran in the February 2013 issue of Applied Clinical Trials, presents a persuasive case for the area’s present desirability as well as a history of steady growth in the past that indicates the Baltic clinical research market is poised to grow. Already it has proven rich in clinical research potential. Consider:

• The Baltic States approve around 80 new clinical trial applications per country each year.

• The biggest part of clinical trials performed are within the therapeutic areas of oncology, neurology/psychiatry, and endocrinology.

• Nearly 70% of the studies performed are Phase III trials.

• States legislation is harmonized and the regulatory process is similar to other EU countries.

• The timelines are attractive-the approval process takes approximately 60 days.

• The region has an appropriate population size to populate large trials.

• Its infrastructure is sufficient and their investigators are experienced and motivated.

• A considerably large pool of treatment-naïve subjects is available, similar to most of the Central and Eastern European counties.

So, where exactly are the Baltic States? Typically, the term refers to three north-central European counties located on the eastern edge of the Baltic Sea-Lithuania, Latvia, and Estonia (from south to north). Together these countries represent a population of 6.57 million in 2012. The Baltic States regained independence in 1990-1991 and entered the European Union in 2004. The States then harmonized their legislation with international clinical trial law and established a friendly environment for clinical trials.

The Baltic States have a significant incidence of oncological and cardiovascular diseases. The environmental burden of these diseases is also above the average world rate given by the World Health Organization. The region has one of the highest cardiovascular mortality rates in the European Union-the situation is worse in Bulgaria and Romania.  Furthermore, similar to most of the Central and Eastern European countries, the Baltics States can offer a considerably large pool of treatment-naïve subjects.

Of all the medicines consumed by Lithuanians, Latvians, and Estonians in 2010, 40.9% were cardiovascular drugs. Other notable anatomical therapeutic chemical groups include: alimentary tract and metabolism (13.8%), nervous system (11.3%), blood and blood forming organs (8.3%), musculoskeletal (8.1%), and respiratory (7.1%) systems.

And if you needed one more positive reason for planning your clinical trial in the Baltic States, it’s recruitment: Doctors there are revered and respected. One of the dominant motives for a patient to participate in a clinical trial is a physician’s recommendation. In the Baltics, this high level of patient’s trust and respect for the physician characterizes physician/patient relations was proven in a study conducted at the Lithuanian University of Health Sciences evaluated patients’ opinions on clinical trials. The study revealed that over 90.7% of respondents trusted in their physicians and that trust significantly increased the possibility of a patient participating in a clinical trial in the future.