What do we mean by data enabled clinical trials?
All clinical trials rely on data to help answer important questions and make decisions about health care. However, only a small proportion of clinical trials that are run in the UK make use of data that is routinely collected by healthcare providers.
Using routinely collected healthcare systems data in research could make clinical trials run more efficiently by:
- Identifying and inviting potential participants more easily
- Ensuring the diversity of people in the trial is close to the population
- Reducing effort in data collection and data entry by removing duplication of effort
- Reducing the need for trial monitors to visit hospital sites to check data
- Following participant’s health over a longer period
- Potentially increasing the number of clinical trials being undertaken
Ultimately, this will lead to more accurate and representative information, resulting in better prevention of disease and treatment for patients.
If you are interested in finding out more about clinical trials or finding opportunities to participate in research, you can find information here.
Why are ‘data enabled trials’ important for cardiovascular research?
There are over 7 million people in the UK living with heart and circulatory diseases. A wide range of data about these diseases and their treatment is routinely collected during hospital and GP appointments, this data can be used within clinical trials when regulatory approvals and appropriate consent from patients are in place. By supporting cardiovascular researchers to use routinely collected data within their trials we hope to be able to streamline and improve the way that cardiovascular clinical trials are run.
Clinical trials are considered as the gold standard for providing evidence to identify the best and new treatments for patients; by focusing on the development of methods to allow streamlined, efficient clinical trials it may be possible to reduce the costs for running clinical trials and allow more trials to be run.
What are we doing?
Working with the cardiovascular clinical trials community we have identified several key areas which will support the use of routinely collected data in trials; Providing Guidance; Developing Best Practice; Standardise clinical outcomes for clinical trials using healthcare systems data; Using leverage to improve processes and data; Targeted driver project activity.
Providing guidance
We have created some guidance for the clinical trials community within the Resource section of our website, this includes Key Datasets and Key Data Access Guidance.
Standardising Clinical Outcome measures in Routinely collected Electronic healthcare systems data
The SCORE -CVD (Standardising Clinical Outcome measures in Routinely collected Electronic healthcare systems data) project brings together cross-functional teams including clinical experts, clinical triallists and health data scientists to develop consistent definitions of trial outcome measures within healthcare systems data. The initial report outlines the plans to develop these outcomes for; Myocardial Infarction (heart attack); Stroke; Cardiovascular Death, Heart Failure and Major Bleeding.
Building the community
We work closely with the clinical trials community across the UK, please get in touch if you would like to talk to us about:
- Accessing health systems data for cardiovascular or diabetes trials
- Developing a data utility comparison (DUCk) – a form of SWAT (‘Study within a trial’) that would allow assessment of healthcare systems data to traditional data collection
- Sharing your experiences with others
- Support materials
Areas of work
Find out more about our data-led research.
Whole Population Data
Better use of nationally-collated, structured, coded data: accessing, improving and using linked, national, population-wide health data.
Defining Disease
Developing methods to define cardiovascular health and disease in computable form through a collaborative network of expertise that provides a world-leading, open, cardiovascular phenotype library of tools and protocols.
Enhancing Cohorts
Facilitating the linkage of large, ‘omics-rich’ cohorts to electronic health records to better understand the causes of cardiovascular diseases.
Imaging
Better use of unstructured data: addressing the challenges of accessing, improving and using unstructured data, for example from cardiac and brain imaging, medical free text and electrocardiograms.
Smartphones and Wearables
Exploring how data from apps and wearables, linked to other health datasets, can inform trajectories of cardiovascular health and disease.
CVD-COVID-UK / COVID-IMPACT
One of seven National Flagship Projects approved by the NIHR-BHF Cardiovascular Partnership, linking population healthcare datasets across the UK to understand the relationship between COVID-19 and cardiovascular diseases.
Diabetes Data Science Catalyst
This exciting partnership between the BHF Data Science Centre, Diabetes UK and HDR UK aims to develop improvements in our understanding of the link between cardiovascular diseases and diabetes.
Stroke Data Science Catalyst
This partnership between the BHF Data Science Centre, HDR UK and the Stroke Association will enable researchers to securely access, link and analyse existing UK health data, speeding up the search for better stroke prevention, treatments and care.
Kidney Data Science Catalyst
This partnership between the BHF Data Science Centre, Kidney Research UK and HDR UK will enable researchers to securely access, link and analyse existing UK health data, speeding up the search for better kidney and cardiovascular disease prevention, treatments, and care.