New Guide Offers Practical Insight Into EU Clinical Trial Lay Summaries
Executive Summary
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.
You may also be interested in...
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.
Pharma Firms Urged To Get Going On EU Lay Summaries
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.
EU Clinical Trials Regulation To Apply From December 2021
Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi.