More Work Needed To Support Transparency Under Clinical Trials Regulation, Says EFPIA
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.
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The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.
The European Medicines Agency says that any changes it makes to its transparency rules on the information that is submitted through the Clinical Trials Information System will be implemented before the end of 2023.
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.