Clinical Trials in Poland – Life Science Krakow Klaster in Investigation
On the picture Kazimierz Murzyn, Managing Director, LifeScience Kraków Klaster
With about 450 studies and 30.000 subjects taking part in clinical trials of new medicinal product and huge percentage of patients includes in global trials Poland is important market for clinical trials. According to a recent PMR report ‘Clinical trials in Poland 2012. Development forecasts for 2012-2014’, Polish ‘market for clinical trials is forecast to expand by an average annual rate of 5% over 2012-2014 and to reach PLN 860m and 580 new trials in 2014” At this same time PMR report state that ‘is worth noting the high proportion of mentions for biopharmaceutical drugs in the current year – 13% compared to 2% in 2010 and 6% in 2008.’, – so Poland seems to be good place for both biosimilars and new molecular entity development.
LifeScience Kraków Klaster take opportunity to ask clinical research professionals about possible reasons of such a situation. Outside faster patients recruitment for clinical research in CEE and lower costs mentioned in report ‘Clinical and Preclinical Research Opportunities in Central Europe (CE)’ by Bioforum there are several other factors quoted during our interviews as epidemiology and demography and standard of care similar to traditional target countries, most of CEE countries belong to European Union, which assure safe common legal framework for clinical trials and IP protection, easy and not expensive sample handling and IMP shipping and logistics for biological and bisosimilar product, traditionally highly educated & motivated CRO employees and investigators, clinical trials considered prestigious and investigators/doctors want to participate in clinical trials. Below we would like to share examples statements from companies working for multinational customers in region, or find in press release or given by to our staff.
“Poland has the largest number of open clinical trials, which accounts for 33% of all open trials in the Central European countries, which is understandable taking into account its size and the level of development of infrastructure and the qualifications of researchers. What is more, the past four years have seen a marked improvement in the assessment of the CEBK’s activities regarding registration of clinical trials by companies operating in Poland: the proportion of respondents positively assessing the CEBK’s activities more than doubled between 2008 and 2012, from 16% to 38%. Another factor is the outsourcing trend which has been visible between global and local CROs. Local small and medium-sized players, which are very much involved in local specifics and can solve many problems, sometimes faster than their international competitors.”said Monika Stefańczyk Head Pharmaceutical Market Analyst, PMR
„In my opinion as well as in the opinion of other professionals conducting clinical research, CEE countries guarantee effective recruitment sufficient number of patients, high quality of data and cost effectiveness both for innovative products as well as for biosimilars. A key to success is a though, proper process of feasibility and individual planning for each trial and by working together with local regulatory and clinical research experts” points out in press release Mariusz Olejniczak, General Manager (Poland) and Chief Operating Officer – Late Stage Projects, Assign Group.
“We have all noticed industry-wide tendency to cut costs. It reflects current economic situation and evolution in traditional pharma company business model. CEE countries with efficient clinical research infrastructure could be an interesting option. It concerns not only fast patient recruitment but also innovation and intellectual input from local experts cooperating in research clusters.
Traditionally R&D centres were based in Western Europe or US. Poland and Krakow become a local leades in business processes outsourcing. Pharma and medical device companies could take advantage of local intellectual potential, investment areas or tax reliefs in special economic zone to set up R&D hubs in this area. This is another attractive opportunity, already explored by some companies.”said Lukasz Partyka , Chief Operating Officer, KCRI, Krakow, Poland.
According to statement in press release by Marek Kiecana, President of KCR S.A (Poland) -, “quality and speed of conducting clinical research are much better than in the US or Western Europe. The Central – Eastern European region (CEE) was repeatedly subject to audits by the US agency FDA ( Food and Drug Administration), which based on own audits carried out around the world, proved, that quality of research is the best in the CEE region, thus better than in the US, Western Europe or Asia. If it comes to recruitment speed, in clinical trials in oncology or central nervous system diseases, recruitment’s speed should be ca 5-10 times higher than in the US or Western Europe”
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LifeScience Kraków Klaster is the collaborative network of institutions and businesses from Krakow region representing diverse areas of interests in life science innovations – science, business and health care supported by economic and regional development. Please visit our web-page to learn more how to collaborate with us.
