Soltel has completed the SmartTRIAL project, a technological solution aimed at improving the management and coordination of multicenter clinical trials within the framework of health data spaces.

Clinical trials conducted across multiple healthcare centers require coordinating teams, protocols, data, and participants in complex environments. Fragmented information, differences between systems, and difficulty accessing relevant data for each study can slow down planning, recruitment, and follow-up processes.

SmartTRIAL addresses these challenges with a platform that facilitates the planning, coordination, and monitoring of networked clinical trials. The solution allows for defining trial characteristics, managing its progress, and conducting controlled consultations with participating centers, maintaining a shared view of the study without centralizing participants' clinical information.

A federated collaboration model

SmartTRIAL has been designed to operate within a healthcare data space environment where each participating hospital or entity retains custody of its clinical information. The platform does not act as a central repository of medical records, but rather coordinates queries and processes with each organization's authorized systems.

This model allows the criteria defined for a trial to be evaluated locally in the relevant clinical sources. Instead of centralizing patient information, the platform receives only the results necessary for each stage of the study, such as aggregated feasibility results, operational statuses, or pseudonymized references where appropriate.

In this way, SmartTRIAL helps research processes to rely on distributed information, preserving data sovereignty, limiting the circulation of sensitive information, and respecting the conditions established by the responsible entities.

From design to monitoring

SmartTRIAL supports the main phases of a multicenter clinical trial:

• Design and preparation: protocol configuration, participation criteria, involved centers and monitoring parameters.
• Feasibility assessment: conducting federated queries to estimate, in aggregate, the availability of profiles that can meet the study criteria.
• Coordinated recruitment: support for operational flows associated with recruitment, respecting the role of each healthcare center in the relationship with its patients.
• Trial management: coordination of tasks, schedules, statuses, and milestones of ongoing studies.
• Analysis and reports: consultation of aggregated indicators and results that facilitate monitoring and decision-making during the development of the study.

The solution uses an AI agent for intelligent searching of unstructured databases to help leverage information from clinical trials that complement patients' medical records. This process takes place within a coordinated research environment, where the data remains under the control of the responsible entities and is used according to established conditions.

Secure and traceable data

SmartTRIAL incorporates mechanisms aimed at ensuring responsible use of health information: access control, application of conditions of use, pseudonymization or anonymization where appropriate, recording of operations and traceability of the queries and processes carried out.

Furthermore, the solution helps facilitate compliance with the legal and ethical requirements associated with accessing and processing health data. These capabilities help participating entities align with the General Data Protection Regulation (GDPR), the European Health Data Spaces Regulation (EHDS), and other applicable frameworks, without replacing the legal, clinical, and organizational responsibilities that correspond to each entity.

Clinical network coordination

The platform has been designed to promote interoperability with healthcare information systems and European data spaces, using healthcare standards and secure exchange mechanisms. This facilitates smoother collaboration between centers, even when the data remains under the custody of each participating organization.

SmartTRIAL provides research teams with a common platform to coordinate multicenter studies, leverage distributed information in a controlled manner, and improve visibility into the different phases of each trial, while preserving each entity's control over its data.

The project's completion paves the way for transferring the developed capabilities to new collaborative clinical research scenarios, where coordination between centers and the responsible use of data contribute to improving the preparation and development of clinical trials.

This project has the financial support of the European Union through the Next Generation EU funds within the framework of the 2024 call for the granting of aid, in the field of digitalization, for the digital transformation of strategic productive sectors through the development of technological products and services for Data Spaces, of the State Secretariat for Digitalization and Artificial Intelligence (Ministry of Digital Transformation and Public Function).