The New EU Clinical Trials Regulation: The Good, The Bad, The Ugly

By Dr. Martine Dehlinger-Kremer, Vice President, Global Medical and Regulatory Affairs

Challenges of the Previous Clinical Trials Directive

The time and costs of conducting clinical trials in the European Union grew significantly.

• Staffing requirements for the clinical trial authorization process for sponsors doubled.
• Insurance fees increased by 800 percent for industry sponsors.
• There was a 98 percent increase in administrative costs for non-commercial sponsors.
• Delays for launching a clinical trial increased by 90 percent to 152 days

Worse yet, there was little cooperation among the Member States and no pooling of expert knowledge. As a result, the number of clinical trial applications in the EU fell by 25 percent from 2007 to 2011.