Taking a Virtual Approach to Clinical Trials
Physical clinical research organizations have an established role in the pharma space, but as the industry faces and prepares for new challenges, what role might virtual strategies play?
Maryam Mahdi | | 3 min read | Technology
Let’s face up to facts – there are challenges when it comes to clinical trials. Patient recruitment can be challenging and dropout rates can be high. Studies often put significant pressure on patients, who must juggle personal commitments with travel and trial participation.
Working with virtual CROs, explains Joel Morse, CEO at Curavit, could be one solution to the multitude of challenges companies face. “The traditional model for clinical trials has worked well for a very long time – and it still does serve a purpose,” says Joel Morse, CEO at Curavit – a virtual CRO. “However, it is inherently complex, with multiple sites, multiple and disparate patient recruitment efforts, and multiple places where data resides. The biggest challenge remains finding patients.”
Morse is passionate about the benefits of using digital tech to improve trials. For example, digital technologies can allow patients to participate in a trial regardless of location. For example, televisits allow patients to meet with the principal investigator of the trial from anywhere via a simple web link. “Patients can report how they’re doing to trial teams via electronic diaries rather than having to go into a doctor’s office,” he says. “They can also handle the often long process of consenting to participate in a trial through e-consent applications and report on progress via e-PRO technology or electronic patient-reported outcome solutions.”
Morse also adds that technologies can enable companies to solve big challenges that are important to regulators and government, including diversity, health equity, and patient centricity. Digital technologies expand patient access to clinical trials across a wide geography because patients are no longer tied to physical trial site locations. Most trials take place at large academic institutions or academic hospitals in major cities, making it logistically difficult, if not impossible, for patients in rural or remote locations or without the financial means to take off work and travel great distances to participate. In fact, 70 percent of all clinical trials worldwide occur at just 5 percent of research sites, which primarily draw patients from populations within 40 miles of trial sites. Digital or DCT technology allows patients to participate from their own homes, eliminating the barrier of travel.
He says, “In my view, the most exciting potential of virtual trials is the ability to reach the large percentage of patients that are not historically exposed to clinical research. Virtual trials are also one of the rare instances where the regulatory environment is providing tailwinds to innovation by creating new guidelines for digital tech use in trials so they can certainly add value to trial recruitment and retention.”
But this does not mean that virtual trials are a panacea to all of the industry’s clinical trial issues. “Sometimes sponsors will try to incorporate digital technologies into a traditional trial that was not initially designed for digital. This has the unintended consequence of pushing new technology onto the trial sites without properly training them how to use it from the beginning, complicating and even slowing down the trial mid-swing,” Mose says. “If companies designed trial protocols by collaborating with DCT experts from the beginning by looking at what aspects of the trial could benefit from decentralization and building those technologies and processes in early, you have the best results.”
But Morse is optimistic about virtual trials. But believes further progress will be necessary to see their widespread use. He says, “Currently too many trials shoehorn technology into a traditional design and end up increasing, not decreasing, patient burden. One day, digital technologies and processes will be an integral part of all trials, natively designed into each one.”