Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal
Executive Summary
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.
You may also be interested in...
EMA To Explain How Trial Transparency & Data Redaction Can Live Together
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.
Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data
EU regulators explain how sponsors who are running integrated Phase I/Phase II trials can overcome default transparency settings in the Clinical Trials Information System to protect the disclosure of dosing details if these contain commercially confidential information.
CTIS: EMA Consults On Transparency Rules & Simplifications For Clinical Trials Portal
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.