Best Practices: Bringing the Trial to the Patient
By Allison Proffitt
May 11, 2012 | 2012 Bio-IT World Best Practices Winner | Almost a year ago, Pfizer started recruiting for a different kind of clinical trial: the first ever conducted under a Participatory Patient-Centered (PPC) model. Last month, the team’s efforts—still very much ongoing—were rewarded with a Bio-IT World Best Practices Award in the Clinical and Health IT category.
The trial, called REMOTE, is structured so that patients can participate regardless of geographic proximity to clinical sites using mobile phone and web-based data capture to conduct all aspects of the trial without clinic visits, including recruitment, screening, consent, randomization, drug shipment, data collection and monitoring and safety management.
Craig Lipset, head of clinical innovation at Pfizer, prefers to steer clear of the “siteless trial” label, however. “My hesitation about that term is that there is an investigator site. We’re required by law to have an investigator site,” he explains. “What’s virtual isn’t the patient, it’s the investigator. The patient doesn’t have to travel. There is still an investigator, but [patients] don’t have to go to them.”
So how should it work? The trial is a Phase IV post-marketing study for the treatment of overactive bladder. REMOTE mimics a previously-completed trial in order to replicate the results and validate the approach. Patients will be able to interact with study physicians remotely 24 hours a day thanks to mobile phone technology and the internet and will have access to medical care as needed. Any drugs are delivered to the patient at home. Stephen Bent, an assistant professor of medicine at the University of California San Francisco, serves as the lead investigator on the REMOTE study.
The goals of the REMOTE trial and the Pfizer team are lofty. This type of trial should reduce geographic limitations in patient recruitment; offer broader patient access and convenience leading to lower dropout rates; save time as subjects can be recruited simultaneously and data capture is in real time; and result in better data quality and improved trial study compliance.
Learning Curve
Since the trial was initially launched, Lipset says the team has learned a lot about recruitment. In the past 12 months, “we’ve been accumulating data on recruitment channels, and shutting off ones that are disappointing us,” he says.
One of the major challenges has been recruiting online without referring physicians. “We’ve been conditioning patients and consumers for many years not to trust what you read online, so it’s a little tricky to engage a patient entirely online,” Lipset says. “Patients have been trained not to trust information online. Overlay that with low health literacy, and we’re really coming in cold with a lot of patients.”
Lipset declined to share numbers or targets, but said, “We’ve been experimenting with many different channels like Craigslist, Google, Facebook, PatientsLikeMe, and others.”
The challenges with recruiting patients online highlighted another issue that Lipset says will be crucial to the success of trials like this in the future: the role of the treating physician.
“The treating physician is an important element we were missing first time,” he says. “In today’s world physicians are given two opportunities: either becoming an investigator (which costs money) or refer your patients. But what are the incentives? Why send patients to other doctors for a study? Health care is still reimbursed based on procedures, so treating physicians wouldn’t do that.” Lipset says the team is now considering ways to use this model to create new opportunities for treating physicians to engage in research.
Team Effort
The REMOTE study team consisted of not only Pfizer and UCSF, but several vendors providing services to facilitate interaction.
Mytrus provides the trial’s Web front end for patients to interact, get informed, and do initial screening. Exco InTouch allows patients to participate and report data with mobile tools. Perceptive Informatics provides a backend database for study data, and tools for randomization. And Greenphire provides compensation tools.
“A lot of these people aren’t out of their comfort zones,” Lipset says of the vendor team. “These companies do this every day; we’ve just put them together in a slightly different way.”
Lipset is very positive about the opportunities for a trial like this. We are asking patients to do quite a bit more—to be more active and invested in their care—which doesn’t describe the typical patient, he concedes. “But brick and mortar trial patients aren’t typical either. We’re looking for a new engagement model for a different type of patient. We need to take advantage of tools and technologies available to reach patients who aren’t now part of the process because they aren’t willing or able to come in every week or two weeks.
“The world of Health 2.0, where we see a couple of hundred patients actively sharing data, tells us that patients are willing to take a more active and engaged role in health and wellness. ePatients are only growing and patients will become more willing and able to participate.”
Beyond the REMOTE trial, Pfizer hopes to widen access to clinical trial participation for both patients and providers. “Every interaction between patient and provider should be a research opportunity,” Lipset says. REMOTE’s broader goal is, “to enable a future state where research can be a seamless part of the background [of patient care].”