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The advent of digital technologies and the widespread use of electronic healthcare record systems provide opportunities to transform the feasibility, cost and quality of randomised trials. However, for this promise to become reality there will need to be major improvements in the ease with which routine data are made available for clinical trials, the processes by which these data are used to recruit and follow-up participants, and the methods for assessing efficacy and safety outcomes. In parallel, changes to regulations that govern the conduct and interpretation of clinical trials are essential. Such regulations must facilitate adoption of advances in health data science and be based on the founding principles of randomised trials – protecting the well-being of trial participants and generating reliable results (which in turn influence the care of many future patients).

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