Central and Eastern Europe Building Clinical Trial Success
News Feb 14, 2011
Clinical trial sites in Central and Eastern Europe have high investigator standards and strong patient interest, making them a prime location for conducting clinical trials, according to a new study by Cutting Edge Information.
High Standards Driving Scientific Confidence
Clinical development executives rated the Central and Eastern European region an eight out of ten when judging the rigor and quality of physicians leading clinical trials at each site. These standards are a critical consideration because loose adherence to safety and data reporting requirements can jeopardize trial results and mislead drug development teams about the benefits and side effects of new products.
"According to the executives interviewed for the study, emerging Europe's investigator standards are approaching those of established European markets," said Jason Richardson, president of Cutting Edge Information. "Improvements are driven by both tougher regulatory requirements for medical research and a growing interconnectedness in which many clinical investigators receive some or all of their training in Western Europe."
Factors for Judging Performance
Cutting Edge Information's new report, "Emerging Markets Clinical Development Series: Central and Eastern Europe," summarizes the study's findings. Researchers looked at thirteen key factors influencing trial quality and efficiency, including regulatory environment and patient access. The study includes comparative ratings for key areas, such as Russia and Poland, and the region as a whole, based on responses from drug and device company executives.
The quality of medical infrastructure emerged as a critical differentiator in choosing successful clinical trial sites. "If development teams focus on urban areas, the standard of care delivered should generally not cause problems," said Jeremy Spivey, senior research analyst. "In some cases, rural areas have infrastructure problems that can lower the standard of care and disrupt clinical trial operations."
Executives noted that higher standards help them meet more of their specific goals:
• Accelerate patient recruitment
• Increase patient retention
• Reduce costs based on comparative advantages
• Protect intellectual property
• Improve clinical trial data quality