Why in Central & Eastern Europe
(CEE)?
Clinical research is becoming more and more complex. High
scientific standards and regulatory guidelines require today
a large number of patients in clinical trials for approval
of a new drug. The average number of patients in clinical
trials tripled since 1980.
The European Commission pointed out in the explanatory memorandum
attached to the project of the EU clinical trials directive
that demonstration of efficacy and safety requires multi-centre
clinical trials with up to 50-60 study centres involved in
a single trial.
These centres spread across more than one country making clinical
development a substantial global process.
Large phase III clinical trials involve even hundreds research
sites all over the world, recruiting into the same study patients
in Americas, Western, Central and Eastern Europe and in other
countries.
Until the fall of the Berlin wall there was some uncertainity
about the quality of the research work in Central and Eastern
European countries. However, as soon as travel to and from
these countries became easier and the internet facilitated
electronic communication of this region with the rest of the
continent it appeared that the CEE scientists are skillful,
talented, well-educated professionals, who are up to date
with the latest developments in their therapeutic areas. These
medical specialists became internationally recognized opinion
leaders in many scientific groups. CEE investigators and the
study sites in CEE are now well-acquinted with the Good Clinical
Practice guidelines which guarantees respectance of patients’
rights, high ethical standards and reliability of the clinical
research process.
They are willing to take part in international, high-standard
research programmes.
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