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Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal

 
• By Vibha Sharma

An analysis of publicly available information in the EU Clinical Trials Information System shows how commercial and academic sponsors differ in their approach to transparency. There are also concerns around the lack of “push back” from EU member states to address potential non-compliance. 

Redacted information texture on white background
There are instances of full-page redactions in CTIS • Source: Shutterstock

Neither commercial nor academic study sponsors seem to be doing a perfect job of complying with the transparency provisions of the EU Clinical Trials Regulation (CTR).

Industry sponsors are more attentive to removing commercially confidential and personal data from their trial documents before making them public, but there have been instances of some “unnecessary redactions,” including...

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