By Ed Miseta, Chief Editor, Clinical Leader
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The world of patient recruitment is changing. Whereas pharma and CROs once relied almost entirely on investigator sites to recruit study participants, patient advocacy groups, social media, and new technologies are creating opportunities to access needed patients. But in doing so, are companies running the risk of further alienating treating physicians?
Craig Lipset, head of clinical innovation at Pfizer, sees new companies popping up in this space that can prevent that alienation. “They are not being specifically billed as a solution to patient and treating physician engagement problems,” he says. “However, we are certainly seeing a range of new solutions emerging that, taken together, provide treating physicians with solutions that did not exist in the past.”
With the exception of healthy volunteer studies, most clinical trials recruit individuals already diagnosed with a disease and taking an existing therapy. Those patients also have a prescription that was provided to them by their physician. Therefore, Lipset feels most trial recruitment effort that goes directly to patients may be viewed as advising patients to go against the recommendation of their physician. Those recruitment campaigns also imply for patients to do the exact opposite of what pharmaceutical advertisements on television are telling them to do, which is to consult with their doctor.
“Many trial recruitment campaigns may think reaching patients directly is more ‘patient-centric’,” notes Lipset. “But not giving patients tools to have conversations with their treating doctor is doing those patients a disservice. Too often this may seem a deliberate oversight, as many treating physicians may not be supportive of a study and view a clinical trial at another location as a threat rather than an opportunity.”
New Firms Target Physicians
In the past, there were many fears that kept physicians away from clinical trials. There was the fear of losing a patient as well as the fear of a loss of control over the health of the patient. But Lipset feels some pride was also involved. Physicians have a tool box available to them, and may feel they have other treatment options for the patient without having to turn to a trial run by another physician. Even if we get past those issues, tools, manpower, and compensation remain sufficient reasons to keep physicians away from trials.
Any solutions meant to reach large numbers of patients will also have to target treating physicians rather than doctors who are already investigators. This approach makes sense, since the vast majority of physicians in this country are treating physicians who have neither referred a single patient to a clinical trial nor participated in one.
To address the tools/manpower problem, Lipset notes the rise of new firms attempting to ease the burden of patient recruitment by bringing studies directly to the physicians who have eligible patients but are not participating in clinical research. Young companies like Elligo Health and Circuit Clinical are actively growing in this area.
“These firms have technologies that can be dropped into a clinic to easily turn it into a clinical site,” says Lipset. “Manpower and information technology is also available to help clinics get through trials more efficiently and without having to make large investments.”
Relieve The Investigator Burden
Lipset also believes the resurgence of virtual clinical trials made possible by companies like Science 37 and Mytrus will be instrumental in getting more treating physicians involved in research. In one virtual trial model, patients participating in a trial are able to continue seeing their primary care physician (PCP) for study data capture even if that physician is not the study investigator. The study investigator may be employed by Science 37, for example, and maintain all of the responsibilities of the investigator, and the patient’s PCP will be responsible for routine trial tasks, such as blood draws. Under this model, the treating physicians are paid for the work they perform.
“Suddenly any physician can see their patient, talk to them, and perform the tests they do on a daily basis,” says Lipset. “In this scenario they do not have to become an investigator, they do not have to worry about losing their patient to a trial, and they get paid fair market value for their work. That concept is transformational, because it is an entirely new opportunity for treating physicians to participate in research. As we continue to roll out these types of models, we have an opportunity to engage with physicians and patients like never before.”
Compensation is certainly another factor keeping some physicians from participating in clinical research, whether they opt to be an investigator or simply refer patients. If time and effort will be required to find and refer patients into a study, most physicians will rightly feel they should be compensated. Lipset notes new platforms are assisting with that process, helping treating physicians find patients using their EHR data. One company, ePatientFinder, is an early pioneer with this approach.
“Solutions like these go the extra mile by compensation the physician their market value to perform bona fide work involved,” says Lipset. “That work includes searching the records, finding qualified patients, and consulting them about trial participation. This process works so long as it is ethical, it is compliant, and it does not involve inducement. Physicians are simply getting paid a fair market value for the work they perform.”
Health Systems Are An Opportunity
By using these new tools, Lipset feels the greatest roadblocks to treating physicians supporting patient recruitment for clinical trials are being removed from the picture. Physicians receive the manpower and tools they need to become investigators, and physicians who simply want to help get patients into trials are compensated for the work they perform. Lipset sees this as a win for pharma, investigators, and patients.
Lipset mentions one additional trend that will have an impact on patient recruitment, which is physicians becoming part of large health systems. He believes this will be an opportunity to improve both patient and physician participation in trials.
Large health systems make significant investments in health information technologies. At the same time, these organizations will generally align physician behaviors to employing their providers under large medical groups. They will have systems in place where physicians are incentivized or penalized for the manner in which they care for patients. Such a system results in the best outcome at the highest quality and lowest cost while maintaining high patient satisfaction.
“This is where health systems are very different from academia,” adds Lipset. “Academic medical centers encourage academic freedom and tend to avoid imposing rules on provider behaviors. Health systems are more rigid, structured, and rules-based. That structure also creates an interesting opportunity for clinical research. If health system executives buy into the idea that research participation is good for patients, lowers costs, and drives higher satisfaction, they are in an ideal position to apply their existing model to drive physician referrals for trials. That can create a win for everyone involved in clinical research.”