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.
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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.
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.
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.