EU Project To Evaluate Delays To Drug Trials Conducted In Combination With Studies For IVDs/Devices

 
• By Vibha Sharma

The European Commission is steering a new member state driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.

Mobile Electronic Traffic Sign stating “expect Delays” taken at sunset with traffic blurred driving past the sign and traffic cones
Clinical Trial Delays Can Block Patient Access To New Treatments • Source: Shutterstock

EU regulators have launched a project to address the challenges faced by sponsors in running so-called combined studies in which the clinical trial of an investigational medicinal product is combined with the performance study of an in vitro diagnostic or the clinical investigation of a non-IVD medical device.

The project is being driven by EU member states and will look at the interface of three EU Regulations: the Clinical Trials Regulation or CTR (536/2014) that came into effect...

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