The European Union's Clinical Trials Regulation is set to raise transparency obligations to unprecedented levels, mandating the disclosure of interim clinical trial results. This change, outlined in Article 37(8) of the EU CT Regulation, will require sponsors to make public the results of every intermediate analysis planned in the protocol, a practice that is currently discretionary.
Impact on Transparency and Clinical Operations
Currently, sponsors are not obligated to disclose interim results unless they voluntarily publish them in a scientific journal. However, with the implementation of the new regulation, this will change. For Phase 1 trials, the posting timeline will be up to 30 months after the intermediate analysis. For later research phases, interim results must be published 12 months after the intermediate data analysis date.
This new obligation will significantly impact clinical operations teams, requiring them to capture the dates of interim analyses to ensure timely publication of summaries on the future European Clinical Trials Portal. The regulation aims to provide greater access to clinical trial data, enhancing clinical intelligence and benefiting the broader scientific community.
Automation as a Key Solution
To ensure consistency, accuracy, and compliance with the new requirements, automation is essential. This begins with the clinical trial protocol, where events must be well-defined to identify their date of occurrence. Sponsors should update their internal Clinical Trial Management Systems (CTMS) to include a transparency sheet with all necessary information for collection in public registries.
Connecting the CTMS to public registry management software, such as TrialAssure REGISTRY and TrialAssure BEACON, can automate the process of pushing data to transparency software, generating compliance alerts and initiating workflows to ensure timely posting of interim results. This approach also necessitates close collaboration with medical writing teams to ensure interim results summaries are posted within the stipulated timelines.
Preparing for the Change
The EU Clinical Trials Regulation represents a significant shift in the landscape of clinical trial transparency. Sponsors must proactively adapt their processes and systems to meet these new obligations. By embracing automation and fostering collaboration between clinical operations and medical writing teams, organizations can navigate the complexities of the regulation and ensure compliance, ultimately contributing to greater transparency and efficiency in clinical research.
