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 20 percent of officially listed clinical trials would not be completed due to inability to recruit participants.
The solution—recruiting via electronic medical records (EMR)—was always just in the offing year after year. But for the most part, there it remained. In the coming months that may finally change.
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 federal financial incentives, 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 massive Kaiser Permanente health care system. But the first nationwide test-drive for this approach will finally kick off this winter.
The clinical trial, 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 funding the study 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 seven participating health care systems 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 Cancer Genome Atlas, a large-scale project at the National Institutes of Health to characterize cancers.
Although millions of Americans with heart disease are told by their doctors to take aspirin, the forthcoming study will assess whether a regular-strength (325 milligrams) or low-dose (81 milligrams) aspirin regimen each day is a better fit for most patients. To get the project off the ground local health care providers had to agree to participate, and they will each decide how patients identified via electronic records will be initially contacted—via e-mail or another approach.
Despite all the excitement about identifying study candidates through electronic records, it also creates new worries. When there are only a few trials using them to enroll participants, there is not a large risk of the same individuals being contacted again and again. If a patient is contacted via e-mail once and asked if she or he would be willing to participate in a clinical trial, perhaps the person would not be annoyed. Once the strategy becomes more common, however, there’s the risk that patients could be inundated with such requests, and a continual barrage of requests might seem like harassment. The early pioneers of using electronic medical records for patient recruitment are struggling to figure out what is acceptable.
In the case of the aspirin trial many local health care networks may contact potential participants via online patient portals they already signed up for, which enable them to easily see their lab test results or other health care information, Hernandez says. Because alerts about changes to patient portals often come via e-mail, however, users may still inadvertently—or intentionally—ignore invitations to participate in a study. The same could also hold true for a direct e-mail from their doctors' offices.
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 request for information 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.
Meanwhile, smaller-scale efforts are also gaining ground. This month a study that will test how lifestyle factors like exercise and Mediterranean diet regimens affect the risk for Alzheimer’s disease is tapping electronic records. Researchers at the University of California, Los Angeles, will lead the study, slated to kick off in the coming weeks. The 200-person trial will draw from patients who have risk factors associated with developing Alzheimer’s disease like obesity and hypertension. Researchers will identify potential trial participants by scouring health care records for relevant insurance billing codes. Then, the researchers will send strong candidates letters with a link to a screening survey. (The researchers are contacting the recruits via post because they do not have most of the contacts’ e-mail addresses and there may be security issues associated with e-mail.)
“We need to find people who are years if not decades away from disease. We would have to recruit widely so this was a good fit,” says co-principle investigator Zaldy Tan, medical director of U.C.L.A.’s Alzheimer’s and Dementia Care Program. As for how future trials could find that sweet spot where people will not begin to look at clinical trial requests like spam, it’s always a balancing act, he says. “We do want to provide information and give participants the opportunity to participate in important studies but not feel like we are forcing them to do so.”