The New EU Clinical Trials Regulation: The Good, The Bad, The Ugly
Source: Synteract
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.
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