What do we mean by ‘data-enabled clinical trials’?

Clinical trials are a way of testing new treatments/approaches in a robust and standardised way. However clinical trials are expensive, requiring substantial resources to identify, recruit, and collect health data from, participants. Many healthcare settings, national databases and registries already collect health data. By using this routinely collected health data (e.g. GP or hospital medical records), we could identify and recruit, or follow-up the health of, participants involved in a trial more efficiently. This could enable more clinical trials to be carried out, including more people, and considering a wider range of follow-up health data over a longer period. This will lead to more accurate and representative information, ultimately resulting in better prevention and treatment for patients.

What are we doing?

Currently only a very small proportion of clinical trials access and use healthcare systems data (also called “routinely-collected healthcare data (RCHD)”). We want to make it easier for scientists and clinicians running clinical trials to use healthcare systems data to support, or replace, data that is collected just for a clinical trial.

To investigate the use of healthcare systems data in cardiovascular clinical trials, we initially carried out a survey, which highlighted clear barriers to their use. To delve deeper into these challenges and explore possible solutions, we organised a workshop, which brought together trials team representatives, including leads and members involved in trial planning, management, coordination, operations, data management and analysis. The workshop particularly drew in people interested in cardiac surgery trials, building on our discussions with Prof Gavin Murphy and the National Cardiac Surgery Clinical Trials Initiative.

Insights from these activities, along with wider discussions, are being used to shape and prioritise the BHF Data Science Centre’s work in this area, with the aim of increasing the number and proportion of cardiovascular clinical trials utilising healthcare systems data. You can read the full report of our findings and outline of our plan here.

Read our report and outline of our plan to facilitate data-enabled trials here