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EU IVD Regulation Delaying Clinical Trials Using Diagnostics

Lack Of Coordination On Performance Study Applications Negatively Affecting Drug Trials

 
• By Vibha Sharma

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Pencil drawn line avoid a crumpled paper ball avoid mistakes concept.
Trial Sponsors Are Considering Moving Studies Outside Of EU To Avoid IVDR-Related Complexities • Source: Shutterstock

Problems in implementing the EU In Vitro Diagnostics Regulation (IVDR) are unintentionally delaying drug clinical trials and blocking patient access to new treatments for conditions like cancer and rare diseases, says the European federation of research-based pharmaceutical companies, EFPIA.

Between 82 and 160 trials involving the use of IVDs to manage study participants are currently delayed in Europe and...

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