e-Records Facilitate Clinical Studies

Electronic health records will substantially accelerate patient recruitment for clinical studies and improve researchers' reach into minority communities, the Wall Street Journal reports today.

EHRs are key to more methodical patient recruitment because they expand clinicians' access to patients fitting the specific parameters required of different studies, the newspaper says. Relying on traditional protocols, it can take years to recruit enough patients for a large clinical trial, since doctors and nurses generally discuss trials only with patients that come in for appointments. Searches of EHR databases can quickly identify patients fitting specific criteria.

The paper describes a GlaxoSmithKline study for a new drug thought to reduce blood-vessel inflammation that can lead to heart attacks and strokes. In just a few weeks one of the company's medical partners, Geisinger Health System, in Danville, Pa., identified 5,300 patients fitting the study's 20-plus criteria. The hospital mailed letters to the patients, fielded calls through a call center, and eventually enrolled 101 patients in the trial.

The streamlined recruiting process could get new drugs and treatments to market faster and at less cost, says Peter Berger, director of Geisinger's Center for Clinical Studies. The average cost to get a major drug or treatment to market is more than $1 billion, the paper says.

At Kaiser Permanente Northern California, meanwhile, researchers scan the facility's database daily for new patients who might qualify for clinical trials for new cancer treatments.

"I think this is the future of how we are going to do studies," Alan Go, director of comprehensive clinical research at the clinic, tells the paper.

EHRs also can speed study execution, submission and reporting of data, evidence-based reviews and evidence-based clinical care, researcher Michael G. Kahn of The Children's Hospital of Denver reports in a presentation, "Integrating Electronic Health Records and Clinical Trials: An Examination of Pragmatic Issues."

Those pragmatic issues encompass privacy concerns, Kahn reports, including who owns and has access to the data collected in the trial and whether any information is reported to health insurance companies.

"Overlapping regulations, competing institutional responsibilities and unclear role boundaries are difficult to untangle," Kahn says in a PowerPoint presentation.

A Canadian study published last year also found that inadequate security for transferring and sharing sensitive files from clinical trials endangered patient privacy. The study, "How Strong Are Passwords Used to Protect Personal Health Information in Clinical Trials?", by Khaled El-Emam of Children's Hospital of Eastern Ontario Research Institute, warned that patients could be stigmatized by the release of personal health information gathered during the trial.

The researchers successfully decoded passwords for all but one of 15 sensitive files sent by email, according to an article about the study by Healthcare IT News.