Clinical Trial Solutions
How about Recruiting Subjects through Their Doctors?
Patient-oriented lay groups and their websites, and of course, social media, have become major new sources for finding clinical trial subjects who are approached directly by the trial sponsor. But Ed Miseta reports in Clinical Leader that this can lead to problems with their physicians, who are out of the loop.
The majority of clinical trial subjects have the disease that the drug under study seems to treat and are taking current medications for it as prescribed by their own doctors. Recruiting them directly can create the perception that they are told to disregard their own physicians or have less confidence in them.
Craig Lipset, director of clinical innovation at Pfizer, says, “Many trial recruitment campaigns may think reaching patients directly is more ‘patient-centric’, 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.”
Attending physicians have often been negative toward clinical trials, seeing them as posing a risk for patients being lured away from their practices and/or for overruling their preferred treatment options. As a result, most doctors have never referred a patient for a clinical trial.
Now new companies, including Elligo Health and Circuit Clinical, have appeared with the aim of approaching attending physicians as a source for trial subjects, presenting the studies to them instead of directly to their patients.
According to Lipset, “These firms have technologies that can be dropped into a clinic to easily turn it into a clinical site. Manpower and information technology is also available to help clinics get through trials more efficiently and without having to make large investments. We are certainly seeing a range of new solution emerging that, taken together, provide treating physicians with solutions that did not exist in the past.”
One such emerging solution, being used by companies like Science 37 and Mytrus, is called a “virtual clinical trial.” The subject’s own doctor gathers much of the data and is paid as a trial investigator.
“Suddenly any physician can see their patient, talk to them, and perform the tests they do on a daily basis,” Lipset explains. “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.”
Still another potential new avenue for subject recruitment via attending physician opens up as doctors affiliate with HMOs. Lipset concludes, “This is where systems are very different from academia. 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.”
It is hoped that these new possibilities will overcome doctor resistance to clinical trials.