EU Aims To Foster Innovation Through Streamlined Uptake Of Clinical Trial Methodologies

Regulators in the EU are to publish a roadmap next year on existing, ongoing and planned guidance activities on novel clinical trial methodologies.

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Innovative methodologies can improve how clinical trials are performed • Source: Shutterstock

EU regulators have kick-started a project to align their views on supporting innovative clinical trial approaches that can improve the design, conduct and analysis of studies for the benefit of participants, researchers and others who use the evidence to make health care decisions.

On 23 November, the European medicines regulatory network set the ball rolling on the project by organizing a multi-stakeholder workshop to gather feedback on selected clinical trial methodology topics, such as the validation of digital endpoints, use of complex clinical study designs, deployment of

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