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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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.
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.