About a year ago, we looked at Clinical Resource Network (CRN), a Chicago-area company with an upside down approach to clinical trial recruitment. Instead of bringing the patients into the clinic, bring the clinic to the patient. At home. At the office. Wherever.
We caught up with founder Gail Adinamis recently, and found her as blunt as ever on the problems inherent in finding patients. “The clinical trial process has not changed over the last three decades,” she says. “We are still trying to operate in the same model. The same inherent problems exist. They have not gone away.” She estimates that three-quarters of all trials might benefit from home-based visits, but says the oncology area has been particularly strong of late due to the difficulty of finding such patients.
Adinamis is polite about it. But she doubts protocol authors have much familiarity with the pressures on ordinary patients. Ordinary people have to hold onto their jobs. Take care of their children. Protocol authors may have different priorities. “You’re writing protocols in your office,” she says. “You’re not thinking about the real world.”
Adinamis believes that the sheer hassle of showing up for an appointment is part of the problem that has been baked into clinical trial recruitment. “You’ll find that a lot more patients are going to be willing and able to participate if they don’t have to come in for every visit,” she says. Her firm works with patients to ensure their participation even during vacations in a different part of the country.
Getting to the clinic is not the only issue. It’s also the time waiting for tests and procedures. Some Alzheimer’s trials may have several hours of waiting, she points out, which can be stressful for both caregivers and the patients themselves.
“We are able to accelerate recruitment by several months,” she says. “We’ve shown it on a rescue basis and a proactive basis.”
The home-based approach, in effect, greatly expands the radius of territory from which a site can recruit. That’s because it takes the issue of driving into the clinic off the table. With logistical issues removed, perhaps half as many patients drop out of the study with a home-based visit. Says Adinamis: “This leads to fewer patients needing to be enrolled.”
With that sort of track record, CRN is currently working with four of the top ten sponsors in the industry, with perhaps half its work coming from biotechnology companies, 40 percent from pharmaceutical companies, and the remainder from genomic and medical device sponsors.
She notes that her business is at the intersection of two highly regulated industries: clinical trials, of course, and home health care. Her firm has standing relationships with 3,000 pre-qualified home health care agencies.
The folks soldiering on in that endeavor, she reports, can be dedicated. In one case, the absence of a road required riding a horse to see the patient. “You can Google-map these patients and there are no roads,” Adinamis says.
Editor’s note: Here’s our earlier story.