Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials

Abstract

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data (RCHD) for at least one outcome were included. RCHD sources and outcome information were extracted. Of 216 RCTs, 102 (47%) planned to use RCHD. A RCHD source was the sole source of outcome data for at least one outcome in 46 (45%) of those 102 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort (NIHR HTA funded trials that had a protocol available) plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of which were carried out in North America (McCord et al., 2019).

Realising the full potential of data-enabled trials in the UK: a call for action

“…It is currently estimated that fewer than 5% of trials in the UK successfully access routinely collected datasets to support trial execution, 31 much lower than the proportion of trials planning to access such data at the grant application stage. 32 Therefore, more is clearly needed to increase confidence and capabilities in the use of routine health data across the UK clinical trials community. In the short term, route maps depicting these dataset details and access methods would be welcomed.…”

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

“…To date, only a small number of trials access RCD to inform participant data, and few provide details on the use of such data sources 18 but designs for trials conducted using cohorts or RCD including administrative databases, registries, and electronic health records (EHRs) are increasingly used in healthcare evaluation. One study carried out in the UK found that almost fifty percent of all publicly funded trials in the UK intend to collect data from RCD sources 19 .…”

Data provenance and integrity of health-care systems data for clinical trials

“…In the UK, 50% of the National Institute for Health and Care Research-funded trials (to 2019) were planning to access and use RCHD. 1 However, looking at the data given to trials from registries between 2013 and 2018, fewer than 5% of UK-based randomised clinical trials obtained RCHD. 2 As notable examples, the RECOVERY 3 and PRINCIPLE 4 trials of potential treatments for COVID-19 have each successfully harnessed benefits of RCHD, which has simplified multi-site data collection through centralised collation and aided identification of potential trial participants.…”

“… 2 As notable examples, the RECOVERY 3 and PRINCIPLE 4 trials of potential treatments for COVID-19 have each successfully harnessed benefits of RCHD, which has simplified multi-site data collection through centralised collation and aided identification of potential trial participants. 5 There is an intention by trialists more widely to make use of RCHD for study design and recruitment through to outcome ascertainment and post-trial follow-up; 1 , 2 , 5 , 6 successful high-profile example trials will encourage further uptake.…”