Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data
Executive Summary
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.
You may also be interested in...
Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal
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.
EU Group Facilitates Switching Multinational Trials To CTR
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”
EMA Addresses Rapid Acting Therapies, Psychedelics In Updated Guidance On Depression Treatments
The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.