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Care Needed With Plain Language Summaries Of EU Study Results

Layperson Summaries Will Be Mandatory Under The New Clinical Trial Regulation

 
• By Vibha Sharma

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.

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Trial Summaries Should Be Non-Promotional And Reader-Friendly • Source: Shutterstock: Castleski

The upcoming EU Clinical Trial Regulation presents a real opportunity to improve research transparency by requiring sponsors to summarize their trial outcomes in plain language but there is already concern that some companies will get it wrong.

There is no provision to check the content of these lay summaries before publication and so ensuring it is done in a strictly non-promotional and balanced way will be no easy task. The topic was covered at a recent virtual Drug Information Association conference on the CTR

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