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EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation

 
• By Vibha Sharma

A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.

Biomarker DNA Strand Medical Research 3d Illustration
Companion diagnostics can support the safe and effective use of a drug by identifying patients more suited to the treatment • Source: Shutterstock

EU drug and device regulators have joined hands to issue guidance on the factors that companies should consider when undertaking clinical trials using diagnostic assays, including combined trials for the development of companion diagnostics (CDx).

Regulations on clinical trials and IVDs in the EU have both undergone significant change recently and the guideline, issued in a Q&A format, clarifies “certain interfaces” between:

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