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EU Offers Advice On Running Complex Clinical Trials Under CTR

 
• By Vibha Sharma

New EU-wide guidance describes the factors that sponsors should consider when designing and conducting trials with complex innovative designs. 

Cancer cells on scientific background.3d illustration
Complex trials are more commonly used in the oncology setting • Source: Shutterstock

EU regulators have issued much-awaited guidance on the scientific and operational aspects of undertaking complex clinical trials under the EU Clinical Trial Regulation (CTR), which came into force earlier this year, ushering in major changes to how trials are assessed and supervised in the region. 

Jointly developed by the European Medicines Agency, the European Commission and the EU Heads of Medicines Agencies, the guideline offers harmonized advice on how companies should plan, set up, seek...

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