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Pharma Firms Urged To Get Going On EU Lay Summaries

Encapsulating Clinical Trial Results For Patients Is Not Easy

Executive Summary

The upcoming EU requirement for summarizing clinical trial results in plain language is a real opportunity for companies to engage with the public. But if companies don’t provide clear and concise information, it may be reduced to a box-ticking exercise.

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

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.

New Guide Offers Practical Insight Into EU Clinical Trial Lay Summaries

Sponsors are being urged to plan early and involve patients in every aspect of preparing the plain language summaries of clinical trial results that will become mandatory when the EU Clinical Trials Regulation starts applying from December 2021.

EU Fine-Tunes Guidance For New Clinical Trials System

With a clear implementation date now in sight for the EU Clinical Trials Regulation, the European Commission is focusing its efforts on finalizing additional guidance and templates to support compliance. The pharmaceutical industry wants access to a test version of the new CT portal so that companies can make the necessary adjustments to their own systems.

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