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EU Offers ‘Timely And Helpful’ Advice On Summarizing Trial Results For Laypersons

 
• By Vibha Sharma

With around three months left for the EU Clinical Trials Regulation to fully kick in, the European Commission has finalized much-awaited guidance offering practical insights into how companies can comply with new transparency requirements mandated under the legislation.

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Preparing Lay Summaries Of Clinical Trial Results Will Require Early Planning By Sponsors • Source: Alamy

The European Commission has issued final guidance explaining how sponsors can comply with the upcoming mandatory requirement under the EU Clinical Trials Regulation (CTR) to publish lay summaries of clinical trial results within specified timelines.

The CTR is due to apply from 31 January 2022, ie the date on which the new Clinical Trials Information System (CTIS) goes live. Many companies have already started putting processes in place in preparation for the lay summary-related requirement, which aims to improve the transparency of clinical trial information

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