The Future of Clinical Trials Is Virtual
WHY YOU SHOULD CARE
Because virtual clinical trials could potentially end the pandemic sooner than traditional ones.
- Travel restrictions during the pandemic have affected traditional clinical trials. Startups like Medable and Unlearn.AI are creating platforms for virtual trials instead.
- These could allow faster clinical trials with larger numbers of participants, potentially allowing cheaper drugs to hit the market more quickly. But virtual trials come with risks too.
Most of the time when a vaccine is being tested, scientists bring in clinical trial participants for in-person evaluations, a crucial part of the path toward approving new drugs. The coronavirus — and the forced quarantines and lockdowns that are only now being lifted — threw a wrench in that process.
Some startups, such as Medable and Unlearn.AI, are using the crisis to disrupt that model by building platforms for virtual trials. They are being tested not just in the United States but also in other countries, including Denmark, where scientists have closely studied their efficacy in specialized fields like dermatology and found virtual clinical trials to be “not only operationally feasible but also successful,” with “higher recruitment rates, better compliance, lower dropout rates.” They can be conducted faster than traditional clinical trials. And given the need to develop mechanisms for clinical trials that can survive travel shutdowns, going virtual has never been more urgent.
The idea of using remote clinical trials to test drugs before bringing them to market isn’t new. The first partially virtual study was in 2001, when Eli Lilly tested the erectile dysfunction drug tadalafil by surveying men via an online questionnaire. A decade later, Pfizer successfully conducted the first fully virtual trial, called REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience).
Despite those early breakthroughs, though, drug manufacturers have been slow to adopt virtual models. Until now.
In April, Unlearn.AI, a San Francisco–based company that’s developing a machine-learning mechanism for conducting remote clinical trials, raised $12 million in funding. Medable, a venture-backed company also based in Silicon Valley, has pioneered a decentralized clinical trial platform that secured $25 million in new funding in May. In a victory lap press release, Medable CEO and co-founder Michelle Longmire stressed that the investment was undoubtedly tied to the extra focus on bringing therapies faster to market. “As we’ve seen with the COVID-19 pandemic, traditional trial processes and timelines are insufficient to meet the global need for clinical research,” Longmire said.
The future of medicine is digital, personalized, data-driven and delivered directly to the patient.
Sunny Kumar, partner, GSR Ventures
Clinical trials constitute a bulk of the cost, not to mention much of the time, it takes pharmaceutical companies to bring drugs to market. Virtual trials not only have the benefit of bringing more potential patients into the fold — allowing companies outside of major urban biotech hotbeds like San Francisco or Boston to better compete, among other things — but also the potential to get faster results and more responsive interactions from prospective subjects. That in turn could reduce research costs and allow firms to charge lower prices. “The future of medicine is digital, personalized, data-driven and delivered directly to the patient,” said Sunny Kumar, a partner at GSR Ventures, when announcing the fund’s increased investment in Medable.
According to mobile technology research company Science 37, its virtual trials have a 97 percent retention rate and are completed 30 percent faster than traditional trials.
A potential legal minefield still awaits pharmaceutical companies. Patient medical information, which must be kept private, is more vulnerable to being hacked or stolen when transmitted online. The veracity of the data may be harder to track as well, particularly with user-submitted results that don’t have direct scientific supervision. And while the Food and Drug Administration has approved virtual trials in some cases, before 2020 it had not released a broad policy supporting them.
That changed in March, when the FDA released guidance advising virtual visits, phone interviews, remote monitoring and self-administration to keep researchers and patients safe while conducting trials. And what may start as a wartime shift could soon become a long-term one, like so many other changes spurred by the pandemic.