Clinical trials are research studies that assess the effects of healthcare interventions in people. They are the best way to assess the safety and benefits of new forms of treatment and prevention, like a new drug or medical device. The use of routinely collected healthcare systems data has the potential to make clinical trials more efficient but to date it has been rarely in this type of research.

The Transforming Data for Trials Programme will transform access to, and the utility, analysis and understanding of healthcare systems data to enable its use in clinical trials – providing research teams with the same reliable outcomes with less effort and reduced costs. The programme will equip the clinical trials community with the skills and technical solutions needed to work effectively with healthcare systems data, across both academic and industry-led trials.

In the longer term, the programme outputs will also allow updated decisions by trial sponsors and funders on how trials and trial teams might be better structured and funded in the future with more efficiency and lower costs, while maintaining, or improving, the quality of trials.

    • Establish a forum that brings together key stakeholders across the UK, including data custodians, clinical trials teams, and the users of the data and research findings
    • Develop a route map providing clinical trials researchers with the tools and resources needed at each stage of the trial lifecycle to effectively use healthcare systems data
    • Curate a catalogue of case studies to demonstrate impact from the spectrum of national and international clinical trials benefitting from enhanced data science capabilities, facilitated through a standard template and including methodological insights
    • Develop a wide range of training resources to enable the clinical trials community to effectively use healthcare systems data
    • Work with patients and the public to develop the strategic aims and planned output of the programme, plus identify patient and public involvement and engagement impact related to the use of healthcare systems data in clinical trials
    • Undertake and support work needed to demonstrate the overall integrity of healthcare systems data for use in clinical trials and assess the utility of these data sources to accurately identify specific health outcomes for trial analysis
    • Cardiff University
    • MRC-NIHR Trials Methodology Research Partnership
    • University College London
    • University of Dundee
    • University of Oxford