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EU Clinical Trial Portal Requires Rethink On Balancing Business Interests & Transparency

Sponsors Can Defer Publication Of Certain Data

 
• By Vibha Sharma

In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.

Macro photo of tooth wheel mechanism with arrows and PRIVATE, PUBLIC letters
Providing More Information On Clinical Trials Can Improve Public Trust • Source: Shutterstock/EtiAmmos

With just 13 months before the new EU Clinical Trial Information System (CTIS) goes live, drug companies are being urged to devise a clear strategy to balance their business interests with the new transparency provisions included in the CTIS portal.

For trials submitted through the portal (ie, evaluated under the EU Clinical Trial Regulation), almost all the information – except for personal data and information on the quality aspects of the investigational medicinal product dossier – will eventually be made public

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