Embedding randomised trials within routine care

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Data collected about an individual's health in medical records, registries and hospital activity statistics is becoming increasingly accessible to researchers in an electronic form. Progress in achieving connectivity, data linkage and security now offers the possibility of better use of this data for research purposes. The ability to identify potentially eligible participants and follow them up through the health system for outcome data is facilitating the embedding of randomised trials within routine clinical practice. 'How can randomised trials become part of routine care and best utilise current clinical care pathways?' was identified as the number one priority in a study amongst patients, carers and healthcare professionals of research priorities for how to improve the process of how people are recruited to clinical trials1.Innovative data-enabled study designs can answer pressing knowledge gaps in research evidence. However, the extent to which such sources of data are now being employed in research to deliver efficient clinical trials, potentially at a wide scale, is unclear. A recent study2 found that around half of NIHR-funded trials ongoing in 2019 in a UK cohort planned to collect outcome data from routinely collected health data (RCHD) sources. However very few trial teams described any assessments of data quality from RCHDs in their protocol. In addition, the pandemic has increased awareness about the ability of embedding trials in routine care, provoking consequent developments in relation to e-consent, e-PRO data capture, etc.What the studentship will encompass The student will gain an understanding of the area through an update of the earlier review of trial protocols2 to describe who is doing what, when and why. They will undertake a survey and/or structured interviews with (i) trialists, to understand the rationale for design choices, including those related to data sources; and (ii) data controllers, to understand interactions with trialists during the design phase from their perspectives. Various issues may emerge from this research, providing the student with options for further research depending on their interest and experience. These may include: understanding engagement with patient-reported outcome data collection, assessment of data quality, understanding and engagement of health professionals and patients, improving adherence to forthcoming SPIRIT-Routine guidelines, international perspectives.Keywords:Healthcare systems data, Outcomes, Clinical trials, Routinely collected data, Data validity, Registries, Routinely collected health data, Randomised clinical trials