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Clinical study potential for electronic health records

But red tape still needs to be reduced if trials are to be simplified

Clinical study potential for electronic health recordsElectronic health records have the potential to streamline the clinical trials process and reduce costs but still face too much red tape, according to a new study.

Researchers using the UK's Clinical Practice Research Datalink (CPRD) recruited patients for two trials, one comparing two statins and another looking at the use of antibiotics in patients with chronic obstructive pulmonary disease (COPD).

The team was led by Professor van Staa, then a member of the CPRD and now based at The University of Manchester's Health eResearch Centre. They installed a new computer programme in 23 approved GP surgeries across England and Scotland that allowed doctors to confidentially identify patients eligible for the trial and sign them up at the click of a button - saving time and money.

The researchers then used patients' electronic health records, as recorded in the CPRD and updated as part of their regular medical appointments, to monitor the impact of the treatments they had been prescribed.

Prof van Staa said: “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.

“This study shows that scientists are able to conduct research which will highlight which treatment is best for patients.” 

In the Retropro trial 300 patients with a high risk of cardiovascular disease were randomised between simvastatin (the generic form of MSD's Zocor) and atovastatin (the generic form of Pfizer's Lipitor). The second study - eLung - compared immediate antibiotics against deferred or non-use in patient with COPD.

Together the studies found research could be conducted with minimal impact on the lives of the patients who, after giving consent, needn't any active involvement in the process.

However, although the statin trial recruited all its required patients, eLung only managed one-fifth of its 150-patient target and Good Clinical Practice guidelines, governance and consent procedures were found to have substantially complicated the trials.

The researchers concluded that trials using electronic health records (EHR) could successfully be used for clinical trials, but that the complexity of the approvals process for studies remains a major challenge.

21st July 2014

From: Research

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