April 2004 – The CenterWatch Monthly : Volume 11, Issue 4, April 2004

Expanding Opportunities in Central and Eastern Europe

Central and Eastern Europe countries have become increasingly popular locations for clinical research, and the interest continues to push eastward as Poland, Hungary and the Czech Republic approach the saturation point. While lower costs remain a draw, access to motivated investigators and patients concentrated in large public hospitals are the biggest advantages. Major sponsors and CROs are all well represented in the region, aided by small but capable local CROs. Though the research infrastructure and regulatory environment is not ideal, positive changes are afoot in eight CEE nations joining the European Union next month.

Pediatric Trials Come of Age

Now that the Pediatric Research Equity Act has become law, re-instating the provisions of the Pediatric Rule, sponsors are expected to make pediatric assessment a regular part of drug development. CROs and SMOs already report an increase in protocols for new pediatric studies since the legislation was signed in December. A new Institute of Medicine report is expected to rekindle discussion on ethical considerations of pediatric trials and could further highlight activity in this market segment.

EU GCP Directive Endangers Future of Investigator-Initiated Trials

When the European Union Good Clinical Practices (EU GCP) Directive goes into effect next month, investigators are concerned that it will impact the role and responsibilities of the sponsor. They fear investigator-initiated studies, which are mainly non-commercially sponsored and conducted at academic medical centers, will be hardest hit.

Eye On: Hepatitis C

Hepatitis C infects 170 million people worldwide and more than three million infections are diagnosed each year. CenterWatch has identified a pipeline of 17 drugs in development for hepatitis C.

• Month in Review
• In the Pipeline
• Opportunities Underway
• TrialWatch