Navigating The EU's Revised Clinical Trial Disclosure Rules
Interim Measures Provide Options For Early Adoption Of The Updated Requirements
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
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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.
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”
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.