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EU Addresses Complex Clinical Trial Designs In New Guideline

 
• By Vibha Sharma

The advent of precision medicine has prompted sponsors to experiment with complex clinical trial designs, which can involve increased operational complexity. A new EU-wide guidance has been issued on the subject to pave the way for a harmonized approach.

Clinical trial
Complex trials are more commonly used in oncology • Source: Shutterstock

An EU group has issued long-awaited guidance on the key aspects that drug companies should consider when initiating and conducting complex clinical trials, which are fast gaining ground as a way to support the development of personalized medicines. The guideline explains the different approaches that sponsors should follow when filing a clinical trial application or requesting substantial amendments for a complex trial as compared to a conventional trial.

The guideline has been issued by the Clinical Trials Facilitation and Coordination Group (CTFG), which functions under the aegis of the EU Heads of Medicines Agencies to coordinate the implementation...

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