New way to run clinical trials in general practice recruits 1,000 patients

New way to run clinical trials in general practice recruits 1,000 patients image

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DaRe2THINK, an innovative approach to delivering remote clinical trials in primary care, has reached a major milestone of recruiting more than 1,000 patients.

The pioneering approach, which will be developed further in the West Midlands Secure Data Environment (SDE), will be targeted to address the health issues in the West Midlands region.

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The trial platform is now active in more than 400 NHS sites, supporting general practitioners (GPs) and their teams to recruit patients for clinical research that can advance public health.

Designed to open up the benefits of research for NHS staff and patients, DaRe2THINK is able to securely screen routine health records for more than 13 million NHS patients. 

The focus of DaRe2THINK is to demonstrate if strokes, blood clots and vascular dementia can be prevented in patients with a common heart rhythm disorder called atrial fibrillation.

A collaboration between the University of Birmingham, NHS providers and the Clinical Practice Research Datalink, DaRe2THINK has successfully implemented a new way to run large-scale trials and to support research in primary care. The trial is funded by the National Institute for Health and Care Research (NIHR) and supported by the NIHR Research Delivery Network across England.

Professor Dipak Kotecha, co-chief investigator for the study, leads the West Midlands Secure Data Environment’s digital clinical trials workstream. He said: “The aim of building these trials into the SDE is to address health inequalities that are a particular problem in our local communities. We will enable our GPs and hospital teams to re-use health data collected as part of normal NHS care, with the objective of preventing poor health outcomes and improving the care their patients receive.

“Bringing these innovations together with the West Midlands SDE will allow us to undertake trials with patients in the comfort of their own home. These trials will help us create real change and improvement in the quality of NHS care and the patient experience. Once the trials demonstrate benefit, we can then implement that change directly into clinical practice for existing and future patients.”

Recent innovations of this efficient, data-enabled approach have led to a ‘number needed to invite’ of 5.3. This means only five patients need to be invited by their primary care team for one patient to be randomised, far surpassing other recent developments in clinical trials. 

Supported by a patient and public engagement team, DaRe2THINK has been designed to transform the way trials can be conducted within the NHS. This will open up participation to a wider range of patients and contribute to the UK’s life science strategy to improve health, wellbeing and economic growth.

Dame Julie Moore DBE, Chair of Health Data Research UK, said: “DaRe2THINK is a new way of undertaking research to improve public health by working with GPs. Through screening of comprehensive health records of patients in the NHS, DaRe2THINK is able to identify patients to recruit to trials to improve their health, and the wider health of the nation.”