Novel approach to clinical trials could prove ‘transformational’

Funded by the National Institute for Health Research (NIHR) and the Department of Health and Social Care, DaRe2THINK is an entirely new way of running large clinical trials for patient benefit in the NHS.

Using innovations focused on data privacy and the security of health information, this approach will allow us to run clinical trials in the NHS without talking up the time of front-line staff or patients, and not requiring any additional visits to hospitals or GPs. DaRe2THINK will use this system in a group of patients with atrial fibrillation (AF) in order to prevent strokes and blood clots, as well as cognitive decline and dementia.

AF is a common heart rhythm condition that leads to a high chance of stroke, frequent hospital admissions and poor quality of life. Patients can also develop cognitive decline in later life (trouble remembering, concentrating or making every-day decisions) that can lead to dementia. Blood thinning tablets, or anticoagulants, greatly reduce the number of patients with AF that will suffer a stroke, but are usually only given to older patients or those with other health issues.

A team of researchers will recruit 3,000 patients from around 600 GP surgeries across England, led by Dipak Kotecha, Professor of Cardiology at the University of Birmingham and Consultant at University Hospitals Birmingham – both founding members of BHP.

DaRe2THINK will test if a newer class of blood thinning tablets widely used in the NHS are cost-effective in younger patients with AF and can reduce the devastating impact of stroke and other blood clots. These blood thinners (direct oral anticoagulants) are more convenient for patients to take, and have a lower risk of bleeding than older treatments such as warfarin.

DaRe2THINK will recruit NHS patients via their GP. In surgeries taking part in the trial, patients who are eligible will be contacted by their GP. The trial is designed to better reflect the diverse UK population and include patients who may not normally be recruited into clinical trials. The DaRe2THINK approach is entirely remote – meaning that patients can join the trial, discuss with their doctor or other local healthcare staff over the phone to give their consent, and complete simple questionnaires using their mobile phone, tablet or any computer connected to the internet. There is no need for patients to come back for trial visits, as information is collected through medical records at their GP and any hospitals they visit. 

Professor Kotecha said: “This approach is a real game-changer for clinical research that can help to improve the lives of NHS patients, and those around the world. At the heart of DaRe2THINK is that health data collected in routine NHS care can be used for important research and the benefit of all patients. In the context of coronavirus, having no visits is really important to keeping our patients healthy, while still giving them the opportunity to contribute to NHS research.”

Dr David Shukla, a GP, Clinical Research Fellow in the University’s Institute of Applied Health Research and the lead for the West Midlands Primary Care research team, added: “DaRe2THINK will allow us to pre-screen from over 12 million NHS patients in Primary Care across England, and direct our efforts to specific GP surgeries to reduce the cost and burden to the NHS. At the same time, we can address major public health problems that affect the NHS, in this case by trying to prevent strokes and dementia.”

DaRe2THINK is being led by the University of Birmingham in collaboration with the Clinical Practice Research Datalink (part of the Medicines and Healthcare products Regulatory Agency sponsored by the Department of Health and Social Care), University Hospitals Birmingham NHS Foundation Trust, Aston University, London School of Economics, and the Nuffield Department of Population Health at the University of Oxford.

DaRe2THINK is supported by a Patient and Public Involvement team, the NIHR Clinical Research Network (West Midlands Primary Care) and Health Data Research UK Midlands. The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS – primary 2 secondary) will start in early 2021 and lay the groundwork for future research in the NHS that will continue to benefit those patients most in need.