Late last month, one of the largest contract research organizations and its parent company announced a partnership with a technology company to promote adoption of virtual clinical trials. But an important subtext to the trend is what has helped drive it over the past few months: the Covid-19 pandemic.
Burlington, North Carolina-based LabCorp, the lab-testing giant, said May 28 that its CRO, Covance, would partner with Medable, a Palo Alto, California-based company that makes software for digital clinical trials, to give patients access to applications that allow them to participate in decentralized trials while also enabling interoperability, remote data collection and engagement between patients, sites and investigators.
“If we were talking pre-pandemic, we would say everyone is curious,” said Allie Holland, Medable’s head of virtual clinical trials, in a phone call. In other words, what was happening before consisted of pilot studies, evaluation of components and the like. “What’s really happened through the pandemic is that it’s accelerated breaking down barriers.”
Bola Oyegunwa, head of virtual trials at Covance, agreed.
“We have seen a significant uptick in that as we’ve engaged with clients,” he said, on the same call. Several customers, he said, have moved away from experimenting with virtual trials to becoming actively interested in conducting studies with a more decentralized approach.
One could say it’s a classic example of necessity being the mother of invention. In March, a survey of 170 clinical trial sites by Continuum Clinical found that many anticipated disruptions due to Covid-19, particularly in their ability to recruit and retain patients. Experts have also said that many drug companies – publicly traded firms and startups alike – face problems enrolling patients, especially for studies of drugs for non-life-threatening conditions, both because of clinics’ focus on caring for Covid-19 patients and perceived threat of the disease among participants. The Food and Drug Administration released a guidance also in March that provided ideas for how sponsors can make up for challenges in areas like data collection, such as by performing virtual assessments.
In a nutshell, decentralization of trials means using technology like telehealth, mobile phones and wearables to enable people to take part in trials from home rather than having to frequently travel to a site, which has historically been the case. The hope is that this will open up trials to more diverse populations, given that study enrollment is often biased in favor of urban and affluent participants, which can skew results.
That doesn’t mean there won’t be challenges to greater adoption of decentralized trials, such as those arising from reluctance and concerns about change. But the hope is that decentralized trials will improve the overall trial experience.
“This challenges sites to amend how they engage with patients,” Holland said. “It certainly isn’t intended to break the physician-patient relationship – it’s intended to enhance the physician-patient relationship.”
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