Leveraging the reuse of Real-World Data (RWD) in medical research comes with key objectives: i) advancing interoperability, ii) promoting harmonization, iii) ensuring data integrity, and iv) establishing protocols for data utilization and access. Yet, the complex legal framework around RWD hinders progress.
From a technical perspective, the absence of shared standards, user-friendly interfaces, structured data, and patient-centric clinical data systems poses challenges.
As highlighted in the insightful commentary paper "What prevents us from reusing medical real-world data in research", it is evident that a paradigm shift is needed in the way we collect and manage RWD. A critical first step in this direction is to implement data infrastructure that is compliant by design, both from a legal and technical perspective.
At AHDB, we recognize that addressing these challenges requires a fundamental cultural shift in the medical research landscape. This shift can be facilitated by an initial change in the technical paradigm currently used to handle medical RWD.
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The new infrastracture for clinical research studies