Cardiovascular Disease and Diabetes Cohorts Trusted Research Environment (CVDD Cohorts TRE)

There are many studies across the UK that collect detailed information about patients with particular diseases and aim to follow their health over many years. These studies are called cohorts. They allow researchers to study the causes of diseases, better understand how they affect patients, and develop new approaches for diagnosis and treatment. With their consent, these studies collect data directly from patients (using questionnaires and measurements) and from specialist hospital and clinic information systems, including imaging scans. They may also collect blood samples for laboratory measurements and information from mobile phone apps and monitoring devices worn by the patients taking part in the study. All of this information is collected into a database. It is particularly valuable for research analyses when combined with data about the health of the patients taking part before they developed the disease and during follow up over many years after their diagnosis. This health data can be obtained from databases collected and held by national NHS organisations, including data about hospital visits, medicines dispensed from pharmacies and death certificates. Obtaining information from these national databases is challenging, time-consuming, costly and - as a result - not always successful. It involves understanding which data are available from which NHS organisation, completing complex applications and obtaining the approval of each relevant organisation. Cohorts also need to provide a secure environment to receive and hold the data, link it together with the other study data, and provide safe, secure access to researchers to conduct their research analyses.

This proposal aims to provide a single platform to overcome these challenges for UK-wide cohorts of patients with diseases of the heart and circulation (so-called 'cardiovascular diseases', such as heart attacks, heart failure and stroke) and diabetes. A dedicated, experienced team will coordinate applications and approvals for cohorts to obtain data from national NHS databases. A secure platform will be provided by a carefully selected, specialist provider to hold all the data collected by each cohort and link it with the additional data from national NHS databases. Specialist health data scientists will provide support for the cohorts in managing, checking, interpreting and analysing this additional linked NHS data. Data from each cohort will be held in a separate, secure space within the platform. Researchers approved to carry out analyses of cohort study data will not take data out of the platform but instead will access it remotely within the platform via a secure log in. To protect the privacy of the patients taking part, all information from which they could be identified (for example name, exact date of birth and NHS number) will be held securely in a separate part of the platform. This identifiable information will only be accessible for essential purposes by a very small number of named cohort study staff. Researchers will not access any of this identifiable information. The platform will also provide specialist tools for the combined analysis of the many different types of data collected by each cohort.

This single platform will allow researchers to answer crucial research questions to improve the care of patients with cardiovascular diseases and diabetes much more quickly, more securely, and at lower cost than is currently the case. In the future it could be expanded to support research on cohorts of patients with a wide range of other diseases.

The UK has a rich collection of cohorts of patients with cardiovascular disease and diabetes (CVDD), each recruiting 100s-1000s of individuals from across the UK. Data collected may include detailed demographic and clinical data, bio-samples for 'omics and other assays, detailed imaging, and personal monitoring data. Cohorts can be significantly enhanced through linkage to routinely collected health data across the life course, enabler richer characterisation and longitudinal follow up of participants. These cohorts have considerable potential to enable research to better understand disease mechanisms, identify new disease subtypes, better predict prognosis, and develop new, personalised strategies for prevention and treatment. They can also provide a major resource for recruitment into experimental studies and clinical trials. However, this substantial research potential is not being fully realised because cohorts struggle to successfully navigate the complex processes for linkage to NHS data, and face logistical and resource challenges in cleaning, curating and securely sharing data with approved researchers. Currently, each cohort usually tackles these challenges alone, with duplicated effort, lack of shared solutions, limited success, and suboptimal return on investment for funders.

The British Heart Foundation Data Science Centre proposes to provide a coordinated, trusted research environment (TRE) platform for UK-wide CVDD cohorts to support recruitment, data storage, linkage to national health datasets, secure, privacy-preserving, remote access to de-identified data by approved researchers, and the provision of tools for managing, curating and analysing multi-source, multi-modal data. This will enable cohorts to reach their full research potential, reducing current inefficiencies, achieving economies of scale and accelerating research outputs. The platform could be extended to support cohorts recruiting patients with a wide range of other diseases.