It’s no secret just how much of a struggle it is to recruit patients to clinical trials, keep them enrolled until the study ends and, finally, get the trial drug approved. And that’s not to mention the huge costs associated with trials which are often unsuccessful or incomplete.
It seems inevitable then that sponsors are beginning to look with great interest at the possibilities presented by virtual or remote clinical trials.
Virtual trials have evolved since the first big internet-based trial in 2001 when Eli Lilly studied its erectile dysfunction drug Tadalafil by conducting online surveys with patients. We’ll look at the benefits of the virtual approach to clinical, and make note some of the persistent challenges that still need to be overcome.
Pfizer was another one of the first companies to conduct a remote clinical trial. In 2011, Pfizer’s Research On Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) trial recruited and enrolled patients via the web.
The major problem was a failure to recruit. The target population were much older than those that tended to use technology. While this has changed significantly in the past seven years, Pfizer’s then Director of Clinical Services, Miguel Orri, M.D., rightfully saw the process as providing vital learnings. These included successfully distributing blinded investigational drugs to patients’ homes and using mobile and web-based tools and platforms for data capture.
Another important takeaway was that “for certain diseases and severity level, offline conventional channels work better than the online channels.”
According to mobile technology research company Science 37’s CEO, Noah Craft, M.D., Ph.D., the firm’s virtual trials have a 97 percent retention rate and are completed 30 percent faster than traditional trials.
No wonder Science 37 has partnered with big names in pharma, such as Sanofi and Novartis.
Most recently, Novartis has expanded its partnership with the firm. The focus will be on having patients and trial staff communicating via mobile phones and telemedicine devices rather than onsite visits.
This approach is a boon to recruitment efforts, Evan Beckman., M.D., global head of translational medicine at the Novartis Institutes for Biomedical Research, explains. Indeed, he cites it as being “superior to traditional hospital or clinic sites” with the ability to include patients from more diverse regions and socio-economic backgrounds.
While trial sites remain an important and often essential component of clinical trials, the choice to conduct a virtual trial can bring with it many advantages. These include better patient engagement, cost efficiencies, improved data capture and empowered research teams.
Not only do they eliminate travel time to trial sites, they provide a safer and more comfortable space (a patient’s home) in which to receive treatment. Patients with mobility issues are also granted reprieve and greater access to trials when they are virtual.
Whether patients are immobile or not, virtual trials allow patients to participate from the comfort of their homes. This makes them more willing to participate and also grants greater access to an increased number of patients by physicians and trial staff, Hand says.
The cost savings are also a major benefit as, while trial staff will likely still be based at a single site or a reduced number of sites in multi-site trials, the operating costs will be significantly lower.
Consider, Hand says, that a single study site can cost between $1,500 and $2,500 a month to manage.
Virtual trials are growing in number, John Reites, at patient data capture platform THREAD, says. The inevitable concern for many CROs is their lack of technological expertise, but Reites explains: “It’s less about tech support, and more about understanding how to use the technology to the best advantage.”
It’s more impactful, he suggests, to think about virtual trials as a new and powerful means of collecting data.
Reites lists the numerous benefits of conducting virtual clinical trials. Not only does the study benefit from better data collection, it also experiences faster timelines, better safety reviews and new endpoints and measures.
Fewer than 5 percent of patients participate in clinical research, 49 percent drop out before the study ends, and new therapies tend to take a decade before they enter the market, according to Josh Rose, VP Global Head of Strategy at health information technologies and clinical research company IQVIA.
These statistics, Rose argues, are clear reasons for making participating in trials as simple as possible for patients — chiefly through virtual trials.
But it’s also the benefits to the research team that makes virtual trials so appealing. Consider that the remotely-based principal investigator and their virtual care team are gathering data constantly. This often results in better “physician oversight” and the ability, with the necessity of onsite visits removed, for researchers to see more patients, Rose says.
The technology underpinning virtual trials also makes the job simpler for researchers. With notifications, scheduling and reporting functions, researchers are freed from performing tedious administrative duties.
There are certain instances for which virtual trials are better suited, Rose argues, such as chronic diseases and less interventional observational studies. These might include endocrinology, CNS, dermatology, respiratory, gastrointestinal, immunology and cardiovascular diseases.
Fierce competition for sites, along with added burden on them from late-phase studies, make virtual trials attractive, Matthew McCarty, global head of patient engagement at development services provider Icon, says.
With patients at home, gathering data at moments that make it easier for them to fit into their daily lives helps guarantee patient retention and trial compliance.
McCarty notes that in some instances, the traditional site-based model will still be required, but opts for choosing a hybrid approach to maximize the benefits listed above. The important qualification of support for virtual trials is, of course, that sponsors partner with CROs or technology vendors to ensure patients can easily use the technology and the data gathered is accurate.
Last year, life sciences company AOBiome Therapeutics shared the results from its 12-week trial of an experimental acne drug. The “randomized double-blind and placebo-controlled trial” showed that the drug spray, containing good bacteria, was “safe and effective,” health journalist Barbara Mantel writes.
She adds that the unique aspect of this largely unremarkable trial is that it was conducted remotely. Trial managers recruited participants through social media and online ads, screened more than 8,000 people online and sent treatment drugs to the 372 final participants via the mail.
Using provided smartphones, patients photographed their acne and sent them in for review and communicated with study staff through video conferencing.
While many are championing the advantages of virtual clinical trials, challenges persist, slowing down their adoption. To date, virtual trials make up “a tiny fraction” of the more than 100,000 registered US-based clinical research studies, Mantel explains.
And industry experts are cautious of a full adoption of virtual trials with problem issues such as a pervasive conservative corporate culture and greater amounts of data to collect, manage and prove reliability to regulators.
Ensuring the technology needed works as it should is also a challenge, Mantel adds. Sensors used to measure heart rates or blood levels need to be working properly for the data to be meaningful. Without any technicians present to monitor the equipment, the risk arises that it won’t operate optimally.
Indeed, the integrity of data is the “main reticence” in the industry of virtual trials, science writer Caterina Lucchini at Pharma World Magazine says, warning that another challenge comes down to standard of care. Without clinicians dealing with patients in person, the concern arises that trial patients will not receive ideal standards of treatment.
The conservatism of corporate executives is “one of the critical stumbling blocks now,” according to Ken Getz at the Tufts Center for the Study of Drug Development.
The concern is with the quality of data that is generated and collected offsite. Getz speaks of sponsor companies being “reluctant to jump into this initiative with both feet” until they know that the data can be trusted.
Virtual trials, at this stage in the industry’s experimentation, remain the exception rather than prevailing practice. However, with cost savings and the potential for greater patient enrollment and retention, it’s likely virtual trials will grow in popularity.
With this future trend on the way, it’s the pharma companies that partner with agile medtech firms that will gain the competitive advantage.
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