The clinical research industry is facing a crisis. Nearly 80% of trials do not meet enrollment timelines, and these delays can amount to $8 million in lost revenue per day, according to one estimate by Cutting Edge Information. But now the industry is betting on a new trend: virtual clinical research.
Sanofi has partnered with Science 37, a remote research technology company. Allowing patients to participate from the comfort of their own homes will ultimately speed up the drug development timeline, “which means patients get the medicines they need sooner,” said Lionel Bascles, global head of Clinical Sciences and Operations of Sanofi, in a press release.
On average, trials conducted with Science 37’s technology have a 97% retention rate and are completed at least 30% faster than a traditional trial, said CEO Noah Craft. The partnership will allow Sanofi to develop remote trials using Science 37 software, which is housed in an Apple iPhone given to each patient in the study.
The Sanofi/Science 37 partnership is the most recent development in a rapidly growing groundswell of interest in virtual clinical trials. Although totally remote research is still a relatively new concept, pharmaceutical sponsors stand to gain millions per trial if decentralization can indeed shorten duration and improve retention, as proponents argue.
The virtual clinical trials approach still has limitations. A Pfizer study launched in 2011 was widely considered a failure, and even today the virtual approach is not advanced enough to attempt in phase I studies or certain diseases that require sophisticated monitoring.
Yet the biggest roadblock to virtual trial adoption is the industry itself, which is highly regulated and “slow to adopt new things,” said Nikki Norris, CEO, Symphony Clinical Research.
Adopting a decentralized approach is like turning an aircraft carrier, said Craft. “It takes a lot of persistence and support when you hit challenges,” he said.
In the summer of 2011, Pfizer launched the first virtual clinical trial to study an overactive bladder treatment. The study, called REMOTE, was met with initial fanfare but was halted in 2012 because of poor recruitment.
In a debrief with Pharmalot, Pfizer’s Head of Clinical Innovation, Craig Lipset, explained that recruiting through social media was a great way to spread awareness of the trial, but did not build enough trust for patients to actually sign up.
Although Pfizer did not meet its recruitment goal, the REMOTE trial was an important first step, explained Norris. Moving forward, it is important to remember that “no matter how automated we can get, you still need a personal relationship to get people involved in a trial,” Norris said.
Ultimately, Pfizer was only able to enroll 18 patients in its REMOTE study, yet results published in 2014 indicated that the study was just as safe and effective as a traditional clinical trial. Then, in 2015, Sanofi announced its own virtual clinical trial called VERKKO, which is being conducted in Europe. Instead of testing a drug, as Pfizer’s trial did, Sanofi’s European study will test a wireless glucose meter in diabetes patients.
If other companies can overcome trust concerns around virtual recruitment, they could see tremendous enrollment interest among patients. Approximately 87% of patients want to participate in relevant studies, according to a study by the Center for Information and Study on Clinical Research Participation (CISCRP).
“If you make the trial easy, satisfying and rewarding for patients, they will want to take part,” said Craft.
There are many benefits of virtual trials other than improving recruitment and accelerating timelines, explained Craft. Specifically, making trials virtual means that patients who were previously excluded can now participate. For example, patients living in rural areas would finally have a chance to enroll without traveling to a central academic center.
In addition, Science 37 studies have a track record of improving diversity among trial participants. “Depending on the trial,” Craft said, “between 30 to 40% of patients are underrepresented minorities.” In traditional trials, minorities only account for 10% of patients, according to the NIH.
However, there are still some areas of clinical research that are not ready for remote monitoring. “It’s not appropriate in a phase I trial because that is the first time a drug has been used in patients,” said Norris. “Patients need to be highly observed and located near a clinical site in case there is a reaction,” she added.
Science 37 doesn’t work on phase I trials for that reason. Other areas that are currently not appropriate are “acute problems, like strokes, which are probably a bad idea to monitor at home,” as well as other diseases that require in-hospital monitoring, Craft said.
Another consideration is the type of monitoring that is required by the study, Norris said. For example, virtual trials might not work if participants will need an MRI, a full physical exam or other types of evaluations that cannot be completed by a nurse during home visits.
Only in the last few years has telehealth technology made this type of research possible. Sanofi’s partnership with Science 37 “sends a strong signal to the world that this is going to be part of the future,” said Craft.
“We see this absorbing a lot of the clinical research space,” said Craft. Moreover, “it opens up new areas of scientific inquiry, like the ability to follow thousands of patients before they become ill, or [for] postmarket surveillance. You have to be willing to try things and fail.”
This article was reprinted from Volume 21, Issue 10, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »