A Salford drug trial, collecting data from more than 4,000 patients using Graphnet’s CareCentric electronic patient record, is providing real-world insight into how patients use and benefit from their medication, one of the study’s researchers has told EHI.
The Salford Lung Study says it is the world’s first pre-licence “pragmatic” randomised controlled drug trial for asthma and chronic obstructive pulmonary disease.
The study is being run by NorthWest eHealth, a non-profit partnership between the University of Manchester, the Salford Royal NHS Foundation Trust and the NHS Salford Clinical Commissioning Group.
The organisation was formed in 2008 to build links between academics and the NHS in health informatics and develop new research using anonymised patient records.
The lung study is using data collected in real time from the Salford Integrated Record, a deployment of CareCentric that collects data from Salford Royal Hospital and 58 GP practices in the area.
The trial has also been expanded to include nine GP practices in Manchester, 17 in Trafford and three in Stockport.
Additional data feeds have been implemented to capture data from out of hours services, community pharmacies and health services outside of Salford, while also recording deaths.
Dr John New, a consultant physician at Salford Royal and one of the study’s directors, told EHI that normal drug trials have strict participation criteria that often restrict involvement to “highly motivated individuals”, limiting what can be learned.
“A lot of the drugs are already very good if you take them regularly… but we know in the real world that only 50% to 60% of people regularly take their medication.”
New said collecting data from the EPR on the number of prescriptions delivered and dispensed, as well as data on hospital admissions, allows researchers to remotely monitor participants’ safety and collect trial data based on real-life behaviour without any interviewer bias.
“They don’t really feel as if they’re in a study, so they behave as they normally would; and we can get a better idea of whether the drug does some good.”
The data collected can also help researchers to understand the cost of asthma and COPD to patients and the NHS and may accelerate new treatments, he said.
New said study participants must give written consent to their data being shared when they visit a GP practice taking part in the project, with strict data-sharing agreements in place.
The COPD study has been running since April 2012, with 2,800 patients taking part, while 1,500 patients have signed up for the asthma study with researchers hoping to recruit another 3,000.
New said he believes the data collection model can be used for other diseases and in other areas.
The COPD study will finish in late 2015, with the asthma study set for completion sometime in 2016. The findings are expected to take nine months to put together and publish, New said.
Brian Waters, chief executive of Graphnet, said: “There are two important benefits to the use of shared records – helping the patient at the point of care, and providing data from the wider health community to support important research work.
“This project led by Salford does both, and shows the real power of collaborative working across multiple NHS organisations.” The research is being sponsored by pharmaceutical company GlaxoSmithKline.