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.
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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.
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.
The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”