Microservices-Based Architecture to Support the Adaptive RECORDS-Trial.

Information systems used by platform trials should handle changes that are not predefined. Unfortunately, the technical architecture of most existing clinical data management systems (CDMS) do not support changes to be incorporated into an ongoing trial. Adaptive clinical trials need advanced architectural solutions setup to enable biomarker stratification and enrichment strategy necessary for the adaptive clinical trial operation. This short paper presents the microservices-based architecture solution that is used to run and support the adaptive RECORDS-Trial.

AP-HP Health Data Space (AHDS) to the Test of the Covid-19 Pandemic.

Sharing observational and interventional health data within a common data space enables university hospitals to leverage such data for biomedical discovery and moving towards a learning health system. OBJECTIVE: To describe the AP-HP Health Data Space (AHDS) and the IT services supporting piloting, research, innovation and patient care. METHODS: Built on three pillars - governance and ethics, technology and valorization - the AHDS and its major component, the Clinical Data Warehouse (CDW) have been developed since 2015. RESULTS: The AP-HP CDW has been made available at scale to AP-HP both healthcare professionals and public or private partners in January 2017. Supported by an institutional secured and high-performance cloud and an ecosystem of tools, mostly open source, the AHDS integrates a large amount of massive healthcare data collected during care and research activities. As of December 2021, the AHDS operates the electronic data capture for almost +840 clinical trials sponsored by AP-HP, the CDW is enabling the processing of health data from more than 11 million patients and generated +200 secondary data marts from IRB authorized research projects. During the Covid-19 pandemic, AHDS has had to evolve quickly to support administrative professionals and caregivers heavily involved in the reorganization of both patient care and biomedical research. CONCLUSION: The AP-HP Data Space is a key facilitator for data-driven evidence generation and making the health system more efficient and personalized.