Electronic health records can help simplify drugs trials, study finds

Research led by the University of Manchester found that medical records stored and updated routinely by doctors could be used to identify eligible participants for clinical trials and monitor the effects of those trials once they have begun. It said the process could deliver better treatments for patients as well as cut down on the cost and administrative burdens associated with running clinical trials.

The University of Manchester said that the study it conducted had involved the installation of a new computer programme in 23 GP surgeries in England and Scotland.

"This programme 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," the University of Manchester said in a statement. "Researchers then used the patients’ electronic health records, as recorded in the Clinical Practice Research Datalink, updated as part of their regular medical appointments, to monitor the impact of the treatments they had been prescribed."

"By studying these records, researchers are 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 research is all conducted with minimal impact on the lives of the patients who, after offering their consent are not required to have any active involvement," it said.

In their report, the researchers said that its study had shown that 'electronic health record point-of-care trials' were feasible (178-page / 5.44MB PDF) and could "greatly simplify trials of medicines". However, they highlighted a number of barriers that could prevent the potential of such trials being realised. The challenges include "complexities in obtaining research governance approvals, recruitment and retainment of GPs and consent procedures for recruiting patients", according to the report. It said that "red tape" needs to be reduced if doctors are to be encouraged to facilitate clinical trials using the electronic health records they store.

"The current research governance system mandates special requirements and conditions to trials, even those that aim to evaluate interventions in routine use," the report said. "As a consequence, only a selective minority of clinicians participate and trial interventions may no longer reflect usual care (e.g due to lengthy consent procedures or requirements to switch trial medication for administrative convenience). Point-of-care trials will have limited scientific value if the trial setting or participants are artificial."

"These trials aim to compare actual clinical decisions (rather than testing biological effects of a molecule) and, thus, will need to replicate these clinical decisions. The concept and practice of research exceptionalism are a fundamental and critical challenge to the use of point-of-care trials," it said.

The report related to pragmatic trials, which are conducted in real-life settings across the full spectrum of the population to which an intervention or therapy will be applied.

"The utilisation of technology such as electronic health records and web based platforms could potentially allow greater collaboration and sharing of data and facilitate the adoption of innovative more adaptive approaches to clinical trials," said life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com. "However, patients will have to agree to be monitored and concerns over data protection and confidentiality will need to be mitigated."