EMA Simplifies CTIS with Revised Data Transparency, Sponsor Deferral Rules
The European Medicines Agency (EMA) has revised the data transparency rules for its Clinical Trials Information System (CTIS), reducing complexities and barring sponsors from deferring the publication of critical data and trial documents.
The revised and simplified data transparency rules, which “strike a balance between transparency of information and protection of commercially confidential information,” according to the EMA, will better serve patients by ensuring that trial information most relevant to them is published early. In particular, it will help improve the user experience for multinational trials, which require sponsors to provide many documents.
The revisions also make it easier, procedurally, for sponsors to protect participant data and commercially confidential information, and for healthcare professionals to navigate the system and access information about trials, enrollment and potential treatment options, the EMA says.
The new rules remove deferral capabilities for every trial category, which had allowed sponsors to delay the sharing of key trial documents, including protocols, for certain types of trials for up to seven years after a trial ended. As part of this, the updated rules narrow the publication of documents to only those most critical to patients and researchers.
The EMA said it is working to fully implement the new rules by Q2 2024. CTIS users will be alerted prior to the rules becoming applicable.
Read the revised data transparency rules here.