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The European Medicines Agency updated the Clinical Trial Regulation (Regulation EU No. 536/2014) to ensure that clinical trials are executed in the subjects’ best interest. Although the regulation went into effect on 16 June 2014, its application depends on the release of the EU clinical trials portal “Clinical Trials Information System (CTIS).”
The European Medicines Agency updated the Clinical Trial Regulation (Regulation EU No. 536/2014) to ensure that clinical trials are executed in the subjects’ best interest. Although the regulation went into effect on 16 June 2014, its application depends on the release of the EU clinical trials portal “Clinical Trials Information System (CTIS).”
European CTIS Initiative
The EU Clinical Trials Register makes clinical trial protocol and results information from the European Union Drug Regulating Authorities Clinical Trial Database (EudraCT) publicly available. It was launched in 2011 and has been enhanced numerous times.
In 2015, the EMA created a new system architecture for an EU Portal, or Clinical Trial Information System (CTIS), consisting of three databases and a data warehouse. There is a safety database, a workspace database for draft documents, and the current EudraCT database for published protocols and trial results.
In 2019, the CTIS development team began using an agile delivery methodology. The latest release was validated in December 2019. It offers improvements to user experience relating to submission and access to clinical trial data and other functional enhancements that promote trial transparency. In December 2020, the EMA initiated an audit readiness assessment that documented outstanding features and functions that still need to be addressed before release.
The development of the CTIS is mandated by Article 80 and 81 of regulation No. 536/2014 and has highly structured interfaces based on specific regulatory reporting requirements.
US MyStudies Application
Like the EMA, the US FDA has also invested in digital tools to help inform regulatory decision-making. The agency’s MyStudies mobile app is free and supports patient input of real-world data from clinical trials, pragmatic trials, observational studies, and registries. The tool was designed to gather real-world data for research.
Unlike the European approach, FDA’s MyStudies application is an open-source platform and is not mandatory. It is being designed to facilitate the voluntary collection of real-life data in clinical trials.
The application has an interface that can support external systems retrieving data from the MyStudies storage environment. Enhancements currently being designed will provide a more streamlined integration with external systems.
The differences in approaches between the two health authorities are due to the underlying regulatory frameworks that are driving each initiative.
Continuing Challenges
The success of the EU Portal assumes harmonization between ethics committees and medicinal agencies in the EU. Though efforts in that direction continue to move forward, there is still more work to be done.
Challenges also arise when submitting a multicenter or international trial conducted in multiple countries (some outside the EU). It can be a time and resource intensive endeavor to submit this complex set of data. Additionally, complex technologies, trial designs, regulatory and developmental pathways can also impede harmonization. Advanced therapy medicinal products (ATMPs) illustrate the level of complexity that must be supported in any technology platform that will support science and innovation of the today and tomorrow.
Some national competent authorities have developed useful platforms that address components of the harmonization debacle. For example, Switzerland (not an EU member state) has the Swissethics platform, a centralized portal where clinical protocols are submitted for review by one of seven ethics committees. This platform works well but is not integrated with Swissmedic, the national competent authority.
Different Approaches to Clinical Trial Information
US FDA and EMA are developing tools that support different regulatory frameworks. Increasing trial complexity and evolving regulations will continue to pose challenges for regulators around the globe. These types of challenges must be balanced by the continuing need for clinical trial transparency.
As platforms and tools evolve, the industry’s need for greater collaboration across geographic regions and regulatory pathways will continue to grow.
