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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...

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