Abstract
BackgroundClinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.MethodsWe conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013 and 2018 for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction were undertaken between January and May 2019.ResultsWe identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (about 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.ConclusionsIn the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined-up thinking between the registries and the regulatory authorities.Trial registrationPROSPERO CRD42019123088.
Highlights
Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth
Results of the search The search and extraction of data were undertaken between January and May 2019; 74 Health Data Research UK (UK) registries holding RCHD were identified and 13 of these maintained accessible release registers (Fig. 1)
The remaining 61 registries were contacted to request information about Randomised controlled trial (RCT) having accessed RCHD, resulting in a further 19 RCTs identified from eight registries
Summary
Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Many national databases and registries collect data that map to common important health-care events such as hospital admission, cancer registration and death. Use of this routinely collected health data (RCHD) to replace or supplement traditional data capture should reduce trial costs, enabling a greater number of large, definitive trials and efficient long-term assessment of health-care interventions. This explains why the use of RCHD in RCTs has been labelled a disruptive technology (i.e. a technology that transforms current practice) [2]. Health Data Research (HDR) UK was established with the ambition of unleashing the potential of RCHD to deliver “Better, Faster and More Efficient Trials” [5]
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