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 routinely-collected data. We want to make it easier for scientists and clinicians running clinical trials to use routinely-collected data to support, or replace, trial-specific data collection.
As an initial step, we carried out a survey to investigate the use of routinely‑collected data in cardiovascular clinical trials, and to explore the challenges faced. The survey responses highlight clear barriers to the use of routinely‑collected data. Respondents reported challenges with ease and timeliness of data access, and with data availability, with many difficulties arising from the processes and bureaucracy involved.
We are now carrying out further investigations to determine how we can address these challenges by streamlining the access to, and facilitating the use of, routinely-collected data in clinical trials.