Challenges of Using Routinely Collected Healthcare System Data in Randomised Trials

There is increasing interest in using individually linked, routinely-collected healthcare systems data for Randomised Controlled Trials (RCTs). These “data-enabled” trials aim to reduce site and participant burden and increase efficiency of trial delivery.1 Routinely-collected data have been used successfully in large ‘big data’ retrospective studies for years,2 and new methodology such as target trial emulation has allowed researchers to reduce the bias inherent to retrospective data.3 This still cannot replace the traditional randomised trial design, but a hybrid approach potentially builds on the strengths of both designs.