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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A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
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.