EU Clinical Trial Portal Requires Rethink On Balancing Business Interests & Transparency
Sponsors Can Defer Publication Of Certain Data
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.
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When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.
Companies readying themselves for the upcoming implementation of the EU Clinical Trial Regulation should think beyond its obvious stated aim of harmonizing the submission and evaluation of trial applications. The regulation, which will be implemented via a new portal, has the potential to affect several business dimensions.
In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.