Using eHealth records for clinical trials

FINDING and selecting participants for clinical trials can be vastly improved through electronic health (eHealth) records. Using eHealth records to understand the best available treatment for patients, from a range of possible options, is more efficient and less costly for taxpayers than the existing clinical trial process. Currently, when researchers want to investigate whether one treatment is better than another they need to organise lengthy and expensive trials that require heavy form filling by patients and GP’s, additional staff resource, regular attendance at appointments and can create artificial test environments that do not represent the reality of patient’s behaviour in regular day-to-day life.

Research* led by Professor T.P. van Staa published in Health Technology Assessment (HTA) on Friday (11 July) looked at the use of statins in 300 people with high risk of cardiovascular disease by tracking their electronic records. 
The study was carried out while he was a member of the Clinical Practice Research Datalink (CPRD); he is now based at The University of Manchester’s Health eResearch Centre.

A second part of the study involved 31 participants and looked at the use of antibiotics in those with chronic obstructive pulmonary disease – where people have difficulty breathing, primarily due to the narrowing of their airways.

For the purposes of this study, researchers instead installed a new computer programme in 23 approved GP surgeries across England and Scotland, which was able to confidentially identify which patients were eligible to take part and allowed doctors to sign up relevant participants at the click of a button, saving time and money for the public purse. 
Researchers then used the patients’ electronic health records, as recorded in the CPRD, updated as part of their regular medical appointments, to monitor the impact of the treatments they had been prescribed.  This was all conducted with minimal impact on the lives of the patients who, after offering their consent, were not required to have any active involvement.

By studying these records, the researchers were able to understand health patterns in relation to specific medications with potentially much larger and more diverse members of the public, and to understand which treatment offers the best results.

“The use of electronic health records in simplifying clinical trials means that we no longer need to remain uncertain about which medicine offers the best health benefits for patients,” Professor van Staa said. “This study shows that scientists are able to conduct clinical trials that will highlight which treatment is best for patients.”

Following participation in the study, interviews took place with 27 GPs, 26 of whom expressed strong support for the use of patients’ electronic records to support clinical trial.

Ten patients were also interviewed who all agreed that discussion of their involvement in the trial as part of a routine health appointment was a wholly acceptable practice. Future studies regarding the use of electronic records in clinical trials will be delivered as part of the Farr Institute of Health Informatics. A national organisation that encompasses four centres of excellence in the field of eHealth research with Centres based in the North of England, East of England and Wales, Scotland and London. The Farr Institute exists to understand how – within the highest ethical standards – patients’ health information can be used to improve public health services.

The study was done in collaboration with researchers from the London school of Hygiene & Tropical Medicine and the Universities of York, Liverpool and Brighton and Kings’ College; it was funded by the National Institute for Health Research and the Wellcome Trust.