As a distinguished physician and life science executive, Dr. Frisch leads our European-based medical and regulatory teams while providing expert guidance and advisory services to our clients worldwide. This post is second in a series from Dr. Frisch on his perspective on the state of clinical research in Central Europe and pan-European region.
In my last post I discussed general observations of things Central European companies could be doing to help offset challenges associated with the high cost of running clinical trials in this region of the world. In this post I explore special considerations for conducting clinical trials in the pan-European region with regards to cultural nuances, language, and regulatory affairs.
Traditionally, this region has been one of the hottest growth areas with regards to the number of clinical trials initiated. In fact, the number of trials initiated in Central and Eastern Europe has more than tripled over the past five years.
When you consider the high standard of care, access to routine medical care, and scientifically ambitious work, the conduct of clinical trials are a big advantage in this region. The reliability of approval processes and speed and efficiency of approvals, data collection, and patient recruitment also make the region attractive.
However, when conducting a trial in Europe, the diversity in cultural nuances, language, regulatory affairs, and other factors offer opportunities and challenges both at the same time. For example, while the acceptance of a certain regimen or drug may be higher than average and such a trial easier to recruit for in some countries, diversity in language, medical, and cultural nuances need to well understood in order to successfully conduct clinical trials in this region.
I consider a thorough knowledge of these cultural aspects as well as local presence as critical aspects of success. Also, it is most important to understand the different regulatory requirements of different countries in this region, as well as to gain practical experience handling a variety of regulatory affairs.