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Combing for clinical trials patients and the best way to make the match between trial and patient is a multifaceted task.
Combing for clinical trials patients and the best way to make the match between trial and patient is a multifaceted task. In this article,Applied Clinical Trials only touched on a handful of companies currently in the trial matching business, each with its own formula. Some direct solutions to investigators, others to patient communities, and still others offer access to claims and EHR data to mine both physicians and patients for potential trial participation.
A new entrant in this emerging territory is ePatientFinder. Its model is physician-directed and takes advantage of a doctor’s need to stay on top of cutting edge treatments, adding in EHR to find eligible patients and topping it off with the ability to provide additional revenue streams for the practice. Tom Dorsett, President and CEO of ePatientFinder, told Applied Clinical Trials, “The biggest difference is that we create trial awareness through the trusted patient-physician relationship.” For example, a Research!America opinion poll found that 72% of Americans say it's likely they would participate in a clinical trial if their doctor recommended it, but only 22% say a doctor or other healthcare professional has ever talked to them about medical research.
How it works
Information regarding a client's clinical trial or those curated from ClinicalTrials.gov is entered into the ePatientFinder platform, which includes geographic site locations, information to educate referring physicians and inclusion/exclusion criteria. The information is directed to the appropriate physicians in the network through matching algorithms and accessed through their mobile app or their EHR. The physician will then review the information and-if they feel like the trial represents a good opportunity for their patients-they opt-in and initiate a three-tiered filtering process.
The three-tiered process is as follows:
Upon presenting for the consultation, the physician will review a pre-screening checklist that addresses additional subjective areas. In making their decision whether or not to refer the patient they also have access to all of the information in the patient's record within the EHR. If they do indeed feel that the patient is a good fit, they will refer the patient through the platform to the closest trial site along with the patient's medical summary to provide the site with greater clinical context.
Referring physicians are compensated fair market value for the amount of time they spend on the consultation with the patient. Most importantly, says Dorsett, they are compensated whether the patient is referred into the trial or not.
Changing healthcare systems
The Affordable Care Act isn’t only about health insurance. It significantly impacts the way that healthcare is delivered-leaning toward accountable care, managing chronic conditions cost-effectively, telemedicine, and consumer incentives from employers for engaging in healthy activities. In addition, the changing landscape of physician practice is a trending from the self-employed or solo practitioner to being part of larger practices within hospital health systems. Only 18% of physicians are in solo practice, according to a 2013 survey from the American Medical Association. Most physicians are in group practices, which in turn are being acquired by larger health systems.
But how does this effect physicians informing patients about new therapies or referring them to clinical trials? First, physicians report less time with patients during a visit-the number is around eight minutes per patient. But on a positive note, Dorsett says that physicians can refer patients to other physicians in their growing health systems, which means no single loss of revenue for their overall employer or themselves. “Primary care physicians are accustomed to referring their patients all day,” says Dorsett. “In addition, the accountable care organizations (ACO) are worried about saving money, as well as providing optimum care for patients. If an ACO is working with a principal investigator in its network of physicians, those physicians can refer patients into a trial, and that trial participation allows the ACO to defray the costs per patient to the sponsor of the trial.”
The readiness of principal investigators doing research in these health systems is explored more deeply in this peer-reviewed article from Applied Clinical Trials.
If a physician is in a large ACO or health system, as outlined above, then the ability to mine more patients within an EHR is also exponential. But saying the words EHR and clinical trials in the same sentence can lead to a bit of doubt. To date, the relation between data mining of electronic health records and the finding of clinical trials patients has been sketchy at best. Says Dorsett, “Early on, the EHR potential for data set up big expectations within pharma, but it just hasn’t provided actionable insights.”
In fact, it was in 2010 when Dorsett first rolled out the ePatientFinder model. However, as Dorsett found, EHR adoption was at a still very low 30%. But with the Affordable Care Act and its EHR requirements, that adoption grew enough for Dorsett to go full-time with ePatientFinder in 2013. “Claims and EHR data hasn’t been so successful and not nearly as robust to satisfy all the requirements of a clinical trial participant,” Dorsett said. “But we can refine a patient database of 2,000 to 20 or 30 through our three-tiered filtering system.”
The growth of ePatientFinder since 2013 has largely been quiet-it has many partners, one is Medidata Solutions, a well-known technology provider in the clinical trials space. ePatientFinder is offered through the Medidata Clinical Cloud platform to help life science companies and CROs find patients through the ePatientFinder network of referring physicians, clinics, hospitals and ACOs that want to connect patients to new treatments.
Its other partners are EHR vendors such as Allscripts and Greenway. Dorsett says that they can integrate with almost any EHR solution available, but he says partnering with the top 10-which own 85% of the market-has proven positive. This is probably a good move. According to this article on the EHR market for 2014/2015, there were 3,600 certified EHR vendors for meaningful use 1. Only 1,600 have been certified for meaningful use stage 2. Additionally, it said, “… 10 hospital EHR vendors accounted for roughly 90% of the market at the end of 2013.”
Physicians and patients
Dorsett is no stranger to healthcare IT, working in this space for 14 years and in 2003 sold his company NuScribe-which offered a voice recognition service for hospitals-for $9 million. In 2008, his daughter who had been born with nevus flammeus or a port-wine stained (PWS) birthmark on her leg, was told during a visit to a specialist to search for treatments online. Dorsett was somewhat taken aback as this specialist offered no real standard of care for this not uncommon condition-it occurs in approximately three out of 1,000 live births. Dorsett quickly found information on PWS clinical trials and treatments online, but was concerned that physicians, even specialists couldn’t stay on top of new medicines. “I thought there was a huge varying difference between the knowledge that specialists could know and take advantage of for their patients.”
In this discovery and research process, Dorsett coupled the fact that physicians don’t have time to keep on top of all developments in medicine and that they don’t have the information on the ready to share with their patients. KRC Research, another public opinion research consultancy, found that physicians use multiple sources to stay on top of medicines, which include CME sources, articles in peer-reviewed medical journals, clinical practice guidelines, and their peers. But four in 10 physicians reported it was somewhat difficult to stay informed about new medications.
Dorsett has found that the physicians using ePatientFinder are excited about what they are learning about clinical research, and the possibilities they are offering their patients. In turn, patients are grateful that their physicians are referring them to potential treatments. They feel more engaged with their doctor.
Of the multiple other avenues out there to match clinical trials and potential patients, Dorsett says, “We could partner with direct-to-patient services, if need be and provide a new type of access. We can be part of the landscape, not competitive, more complementary.”
“Patients that are aware of trials will continue to find them on their own. However, we address the much greater segment of the population that is unaware and would otherwise not likely ever participate.” And as clinical trials become more of the patient treatment continuum, rather than the treatment of “last resort,” physician knowledge will continue to be a cornerstone in clinical trial delivery.