Real-world evidence gathering in oncology: The need for a biomedical big data insight-providing federated network
Geldof, Tine Huys, Isabelle Van Dyck, Walter
Geldof, Tine
Huys, Isabelle
Van Dyck, Walter
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Publication Type
Journal article with impact factor
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Supervisor
Publication Year
2019
Journal
Frontiers in Medicine
Book
Publication Volume
6
Publication Issue
43
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Abstract
Moving towards new adaptive pathways for the development and access to innovative medicines implies that real-world data (RWD) collected throughout the medicinal product life cycle is becoming increasingly important. Big data analytics on RWD can obtain new and powerful insights into medicines’ effectiveness. However, the healthcare ecosystem still faces many sector-specific challenges that hamper the use of big data analytics delivering real world evidence (RWE). We distinguish between exploratory (ExTE) and hypotheses-evaluating (HETE) studies testing treatment effectiveness in the real world. From our experience and in the context of the four V’s of data management, we show that to get meaningful results data Variety and Veracity are needed regardless of the type of study conducted. More so, for ExTE studies high data Volume is needed while for HETE studies high Velocity becomes essential. Next, we highlight what are needed within the biomedical big data ecosystem, being: (a) international data reusability; (b) real-time RWD processing information systems; and (c) longitudinal RWD. Finally, in an effort to manage the four V’s whilst respecting patient privacy laws we argue for the development of an underlying federated RWD infrastructure on a common data model, capable of bringing the centrally-conducted big data analysis to the de-centrally kept biomedical data.
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Keywords
Real-world Data, Real-world Evidence (RWE), Oncology, Data Exploration, Federated Network, Common Data Model