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More Work Needed To Support Transparency Under Clinical Trials Regulation, Says EFPIA

 
• By Vibha Sharma

Research-based drug companies believe the EU guideline on protecting confidential business and personal information in the clinical trials portal CTIS addresses some key concepts, but they point to the need for greater clarity and simplification going forward.

Clinical trial
The EU Clinical Trials Regulation Seeks To Improve Research Transparency • Source: Alamy

Protecting commercially confidential and personal data while using the EU Clinical Trials Information System (CTIS) has proved a tricky aspect of the Clinical Trials Regulation (CTR) that has ushered in strict transparency requirements.

While the recent EU guidance on this topic addressed “some fundamental concepts with which industry has been struggling,” further clarifications...

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