ALLURE
reAL worLd data UtREcht: the Utrecht Real World Data Research Infrastructure for Personalized Medicine
Every day, vast amounts of valuable clinical data is generated in medical centers. To make optimal use of these routine data the UMC Utrecht started an infrastructure which integrates research into routine clinical care; the UMC reAL worLd data UtREcht (ALLURE) infrastructure. The essence of this infrastructure is to give every patient the opportunity to contribute to or participate in research and be part of a learning health care system. This way, clinicians and researchers can learn from every patient, with the aim to continuously improve our understanding of diseases, and improve patient outcomes (in particular (disease-free) survival and quality of life).
Infrastructure and User Services
The ALLURE (reAL worLd data UtREcht) infrastructure aims for standardized entry of routine clinical data in electronic health records (EHRs), automatic extraction of (un)structured data, in combination with structured data collections and linkages with several organizations (e.g. Netherlands Cancer Registry, Julius General Practitioners Network, Foundation for Pharmaceutical Statistics) to obtain high quality baseline and follow-up information. All patients will be systematically invited to contribute to and participate in clinical research, through an (e-)visit the ‘innovation clinic’, or during hospitalization/hospital visits. Research personnel will inform patients about the importance of patient participation in clinical research, and about privacy protection policies.
Patients are asked to provide informed consent for:
- Use of their routine clinical data for translational and clinical research, deep learning activities, product development and linkage to national and regional health databases.
- Storage and use of biomaterials (e.g. tissues, liquid biopsies) and medical images.
- Repeated patient reported outcomes questionnaires (PROs).
In addition, patients are asked to give ‘broad informed consent’ to be invited for future studies, including randomization according to the Trials within Cohorts (TwiCs) design to participate in intervention research. After randomization an additional informed consent is asked of patients in the intervention arm, before any study treatment is started.
ALLURE currently consists of different disease cohorts (e.g. cancer, infection and immunity, cardiovascular diseases and cancer) enriched with real world data. The concept has proven to be feasible in regional (UMBRELLA-breast cancer, Utrecht Cardiovascular Cohort-cardiovascular disease), national (PLCRC-colorectal cancer) and international settings (MOMENTUM-patients treated with MRI-guided radiotherapy, MEN-1-endocrine tumors).
Examples/description of the type of research
ALLURE creates a data infrastructure in such a way that all consents are in place to facilitate different types of studies using this infrastructure. This can be different types of study desings, including randomized trials according to the TwiCs design, but also more etiologic, diagnostic and prognostic studies, including AI methods, are possible in ALLURE. In ALLURE patients are systematically asked to consent to use of clinical data, patient-reported outcomes, and blood/tissue banking, via an (e-)consult at the “innovation clinic” or during hospital visits. Patients may give broad consent for future studies, so that in future, when eligible, they may be (randomly) offered experimental interventions. ALLURE generates large representative, GDPR proof study populations and serves as a multi-trial facility for comparison of effectiveness of new interventions against standard care. A wide range of studies (molecular biology, biomarker validation, technical development, artificial intelligence, and randomized trials) have been/are/will be completed. ALLURE gives every patient the option to be part of a learning health care system, and contribute to continuous improvement of clinical care and outcomes.
How to access the infrastructure?
ALLURE organization and workflow, its cohort specific approaches, and its real-world data are available to the wider research community and policy makers. In the coming year we will work on further harmonization and standardization of access rules and regulations as well as a single point of entry for patients and users and align the procedures with the national procedures and EHDS. In the current procedures, researchers from in- and outside the UMC can request data and samples following a standard data request procedure after which tailor made datasets will be made available in a secure processing environment.