EU and US regulators are closely aligned in their efforts to support modernization in clinical research and their recent recommendations on decentralized clinical trials (DCT) are a testament to this fact. There are, however, some differences between the two regulators when it comes to their advice on running DCTs.
EU regulators offered their harmonized perspective on the use of decentralized elements in clinical trials in a final recommendation paper in December 2022. The US Food and Drug Administration published its draft DCT guidance in May, with stakeholder comments due 1 August
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?