The scheme sounded too good to be true: with a few simple clicks researchers could identify thousands of people who would be a good fit for trials testing certain drugs or therapies, thanks to their geography, rare disease or risk factors like obesity. The promise of this method, researchers crowed, would allow them to leapfrog over the gaping chasm between the number of people typically needed for clinical trials and how many stumble across relevant advertising or meet with recruiting doctors. Gone would be the days where as much as of officially listed clinical trials would not be completed due to inability to recruit participants.
Faster, smoother clinical trial recruitment hinged on hospitals and clinics moving to electronic records that would capture patients’ health and demographic information. Then that bounty could be shared across facilities. Now many health care providers, prodded along by , have finally started regularly using electronic records. Yet even with that change there are very few large-scale research efforts that take advantage of the data.
Part of the obstacle is still logistical. If one health care system uses one kind of EMR, it may not be compatible with that of another system—and privacy restrictions may prevent facilities from sharing the information anyway. There have been a handful of efforts that tapped electronic medical records for prospective recruitment for clinical trials, usually drawing from within the health care system. But the first nationwide test-drive for this approach will finally kick off this winter.
, led by researchers at Duke University, will evaluate the best daily dose of aspirin for patients with heart disease. The study, which will begin in December, aims to recruit 20,000 people using electronic health records, and participants will be randomly assigned one of two drug regimens. “This will be the first study using this method but the aim is to do this across medicine, across health conditions and with both common and rare diseases,” says Adrian Hernandez, a cardiologist at Duke University School of Medicine and one of the researchers heading up the work.
The Patient-Centered Outcomes Research Institute (PCORI), an agency created under the 2010 Affordable Care Act tasked with studying the effectiveness of various medical treatments and procedures, is to the tune of $14 million. It will be the first conducted through the institute’s National Patient-Centered Clinical Research Network, or PCORnet.
To make this EMR recruitment tactic work will feed their electronic health records into a software program that coverts the raw records into de-identified and searchable participant information that is stored in a secure central database. That way, researchers will be able to pick up certain health information from patient records regardless of which system they came from.
Such an approach would be a game-changer. “Now we basically have to do a lot of publicity and go to all these doctors’ offices to see if they have anybody that would be a good fit. There is no centralized place where all that information is stored—and if there was, it would be much easier,” says Jean Claude Zenklusen, director of the a large-scale project at the National Institutes of Health to characterize cancers.
PCORI is not the only group interested in making the electronic-records recruitment work. In June the U.S. Food and Drug Administration published a about such approaches and asked how research for drugs would be improved by ramping up such systems. The NIH, too, has started funding research efforts to develop a network of sites that can share EMR data.
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