Decades in the making: A wet lab for digital health and the evolution of research data infrastructure (Preprint)

Abstract

UNSTRUCTURED Traditionally, medical research is based on randomised controlled trials (RCTs) for interventions such as drugs and operative procedures. However, increasingly there is a need for health research to evolve. RCTs are expensive to run, are generally formulated with a single research question in mind and analyse a limited data set for a restricted time period. Progressively, health decision makers are focussing on the real-world data (RWD) to deliver large scale longitudinal insights that are actionable. RWD is collected as part of routine care in real-time using digital health infrastructure. For example, understanding the effectiveness of an intervention can be enhanced by combining evidence from traditional RCTs with RWD, providing insights into long-term outcomes in real-life situations. Clinicians and researchers struggle in the digital era to harness RWD for digital health research in an efficient, ethically, and morally appropriate manner. This struggle encompasses challenges such as ensuring data quality, integrating diverse sources, establishing governance policies, ensuring regulatory compliance, developing analytical capabilities, and translating insights into actionable strategies. The same way that drug trials require infrastructure to support their conduct, digital health also necessitates new and disruptive research data infrastructure. Novel methods, such as common data models, federated learning and synthetic data generation are emerging to enhance the utility of research using RWD often siloed across health systems. A continued focus on data privacy and ethical compliance remains. Establishing strong cross-sector collaborations among healthcare and academic institutes will further promote a learning health system. The past 25 years have seen a notable shift from sole emphasis on traditional medical research to the inclusion of modern-day methods, harnessing RWD. This paper describes the evolution of research infrastructure developed to support digital health research and shares the lessons learned as a model for other jurisdictions with similar RWD infrastructure requirements.