October 21, 2019
The clinical trials industry is divided on the value of virtual trials, with some thought leaders extolling their benefits and others decrying the loss of personal contact between patient and trial.
Relying on digital solutions for data-gathering and communication, sponsors and research organizations can reach patients that might otherwise not be able to participate and can save money by cutting the trial site out of the equation.
“Conducting trials virtually has a compelling economic reason — to cut the site out completely — but patients don’t want to participate in a trial in a vacuum,” says Ken Getz, director of the Tufts Center for the Study of Drug Development.
“They still want to feel that they are in a relationship with professionals that will help guide them,” Getz says.
While a completely virtual and “site-less” approach may be feasible for running some late-phase trials that deal with less life-threatening indications, early-phase and investigational cancer trials might require a physical site visit to conduct an MRI or intravenously administer a medicine with more medical oversight.
The question to be considered is, do patients value the convenience of virtual trials more than the relationship aspect of site-based trials?
Virtual trials might be too abrupt or impersonal, says Getz. One of the benefits patients get from trials is access to professionals or experts that can give them special attention. “For select trials, this may actually make sense. But as an across-the-board solution for all trials, it’s hard to see [virtual] being viable.”
Pfizer made the first attempt at a virtual trial in 2011 with its REMOTE study, an entirely home-based clinical trial for overactive bladder disease. For that study, informed consent was obtained online and documented by electronic signature, and the study drug was delivered directly to subjects’ homes. Adverse event reports and efficacy outcomes were recorded using mobile devices and web-based tools. But the study ultimately failed to recruit enough patients.
Since then, FDA interest in virtual trials — which the agency refers to as decentralized trials — has increased as it seeks out new and innovative approaches to drug development.
The FDA has created a working group that is reviewing the concept of virtual trials, which will likely lead to a guidance on the subject. There is no date set for releasing a draft guidance.
In the meantime, the industry is developing different approaches to the concept of virtual trials.
A hybrid model, which mixes remote data collection with clinical site visits, can reduce the burden on study participants while maintaining the personal connection, according to Lindsay McNair, chief medical officer with WCG Clinical.
One example of the hybrid model is VirTrial’s trial management platform, which combines video, text and email communication to help clinical trial sites address specific patient or study needs. The platform can be customized to meet both patients’ and sites’ needs.
“We are not trying to replace sites,” says Amanda Rangel, vice president of business development at VirTrial. “Our trials are not 100 percent virtual trials. Our approach is to focus on the human element.”
VirTrial hopes to replace 25 percent to 40 percent of standard trials with its hybrid approach, which combines in-person visits with digital interaction to make the clinical trial process as accessible and easy as possible for patients.
VirTrial’s platform, which claims to be best used with Phase 3 and 4 studies, aims to help patients communicate with doctors and trial staff using their mobile devices, getting answers to questions as simple as, “Am I allowed to take Tylenol?” And VirTrial’s matrix of trial staff contacts means someone is always available to answer those questions.
“We know that if something is not easy to use, the patients and sites won’t use it,” Rangel says. Enhancing communication between patients and sites keeps the patient engaged, she says.
Transparency Life Sciences (TLS) is taking a fully virtual approach and has tested its first all-virtual trial concept. By simulating all the procedures required for a pulmonary function trial, TLS has built a foundation for future virtual trials.
“We are the first enterprise that was built entirely on the hypothesis that clinical trials will go virtual eventually,” says Tomasz Sablinski, TLS founder and chief executive officer.
Participants in the TLS Virtual Siteless Technology Open Research (VISITOR) project were able to record data commonly collected in clinical trials — blood pressure, heart rate, body weight, for example — and use a single-lead EKG to monitor pulmonary function, uploading it digitally to the study hub from their homes or offices.
“This creates a template or scaffolding, says Sablinski. “We can build off that and do studies which follow those considerations.”
Striking a middle ground between the VirTrial and TLS models, IQVIA takes a more flexible approach to the balance between virtual and personal.
When IQVIA starts looking at a study, says Josh Rose, vice president and global head of strategy, first it examines the protocol and determines where traditional aspects of the trial can be replaced with virtual ones.
“We look at patient burden and we look at the study with five or six visits and what [aspects] of those visits can be moved to the patient’s home,” Rose says. “Sometimes it can be the entire study. But It’s not black and white.”
As sponsors continue to show more interest, creating virtual trials becomes more of a balancing act for combining technology and scientific research. But just because there are numerous technological tools available now for virtual trials, McNair says, that does not make them complete solutions for study conduct.
There is a misconception that virtual trials are all about putting technology and a study on an app, but nothing could be further from the truth, Rose says. “Phase 3 and 4 studies are complex. There are lots of safety precautions and measurements. It’s sending the wrong message.”
Sablinski says that 25 percent of current studies could be done entirely virtually but the concept still is only a blip on the industry’s radar.
“As we get better at integrating solutions, we may create a more customized approach,” says Getz. “That relationship between the patient and investigator is important and so are the ways to continue to reinforce that relationship.”
Researchers in the future will need experience in thinking about the unique design, conduct and ethical challenges of virtual clinical trials, McNair says, as more of them move toward this model of research.
By Colin Stoecker