Transparency Provisions In EU Clinical Trial Portal To Be Reviewed In 2023
Public Consultation Expected In Q1 Next Year, Says EMA
The European Medicines Agency’s management board believes it is time to review the disclosure rules under the EU Clinical Trial Regulation that were agreed almost seven years ago.
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Revised transparency rules for the EU Clinical Trials Information System aim to deliver earlier publication of key documents of interest to patients and researchers, including study protocols, as well as a significant simplification of the system for sponsors.
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.
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.