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Volume 55, April 2007 |
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Featured Industry: Clinical Research Clinical Trials in Central Europe: Focus on Poland Clinical trials are the basis for determining the safety and efficiency of pharmaceuticals, biologics, and medical devices. They are a field of science which is subject to strict rules specified in the legal acts pertaining to the industry so as to protect the subjects by means of appropriate procedures for organizing, monitoring, and controlling each trial. According to research firm Euromed Communications, Central and Eastern Europe (CEE), which includes Poland, plays a vital role in global clinical R&D. With 350 million inhabitants CEE has become the second source of Caucasian patients in the world for commercial trials, after the U.S. Poland, for example, has seen the number of clinical trials soar to around 400 per year from below 100 in 1997, according to Grzegorz Litynski, senior regional manager for i3 Research, as reported in "The Pharma Times" (2007). Clinical Trials in Poland The Economist Business Intelligence Unit, in its April 11, 2007 country report, attributes Poland as a particularly attractive location because of the steady flow of willing patients who ask to take part in trials. These patients are enticed by the free medicines and additional diagnoses such as x-ray scans. According to consulting and market research company PMR, the value of the Polish clinical trials market is forecasted to increase by as much as 10-12% in 2007. It attributes this growth primarily to the improvements in the quality of co-operation with the Central Evidence of Clinical Trials (CEBK), the institution responsible for registering clinical trials in Poland. At the end of 2006, the CEBK published a list of new requirements aimed at streamlining the trial registration process. Under the new requirements, the authorities have waived the requirement for notarial authentication of certain documents (i.e. GMP certificates) each time a firm applies for permission to conduct trials. In addition, applicants are no longer required to submit copies of their entries in the KRS (National Courts Register) for agreements concerning conducting clinical trials between parties within Poland. Why Clinical Trials Are Moving East Pharmaceutical companies are increasingly shifting clinical trials to emerging markets - as much as 40% of all drug trials in 2005, up from about 10% in 1999 (FORTUNE Magazine). Trials continue to shift to poorer countries in search of more patients, lower costs, and faster recruitment. Further, many of these countries have centralized health systems; meaning that hundreds of patients with similar symptoms are found in the same place. And, the subjects often have not built up resistance to new drugs from years of antibiotic treatment. The shift from the U.S. and the UK to poorer countries is largely being driven by economics - translation, faster time-to-market equals lower costs. In 2005, FORTUNE named Russia is the frontier, but noted that as it gains experience and improves its research standards, costs will inevitably go up. Drug companies are already well established in Poland and the Czech Republic and are looking farther east (i.e. India and China) for new testing locations. To find out more about the clinical research industry, visit this issue's useful links and the detailed section outlining upcoming events. Sources: "Clinical trials in Poland 2007, Poland compared to other Central and Eastern European countries," a report published by PMR (2006). Bhatt, Arun, "(Clinical) Trials and (Regulatory) Tribulations," published in the Express Pharma Pulse (2003). "UK Regulations - Tougher on Drugs," published by The Economist Intelligence Unit (2007). Lustgarten, Abrham, "Drug Testing Goes Offshore," FORTUNE Magazine, August 2005. |
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