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Social distancing meets clinical trials
HORSHAM, Pa. & LOS ANGELES—Remote clinical trials didn’t start with the current global pandemic, though the interest for them is certainly growing fast as many studies face delays or the risk of cancellation due to social distancing and concerns over patient and researcher safety.
In that vein, early April saw PPD Inc. subsidiary Accelerated Enrollment Solutions (AES) and virtual clinical trials company Science 37 announce that they will collaborate to recruit and enroll clinical trial participants who live beyond the geographic location of traditional research sites—and they will work to rapidly deliver continuity solutions for clinical trials affected by COVID-19, including the use of telehealth to remotely screen patients and conduct study visits.
The collaboration enables AES to provide its customers with increased patient access by reaching beyond its existing physical site infrastructure of more than 180 research sites. These patients can instead participate in AES studies through Science 37’s Metasite, a hybrid clinical trial methodology that combines traditional site visits with remote trial capabilities, allowing patients located virtually anywhere to participate in a clinical trial. The collaboration also enables Science 37 to extend its investigator network by leveraging AES’ global research network. In total, the collaboration offers multiple combinations of traditional and virtual visits for conducting highly patient-centric trials around the world.
“We are pleased to provide our customers, through our collaboration with Science 37, one of the most advanced, trial-tested approaches to clinical research virtualization,” said Roger Smith, general manager of AES. “By offering the Science 37 Metasite in conjunction with our existing network, we give our customers a taste of the future, while more patients will have the opportunity to participate in trials that might otherwise be unavailable due to location restrictions.”
In addition to managing its global research sites, AES coordinates startup, patient enrollment and study conduct under a single contract via centralized and controlled processes. Concurrently, Science 37 oversees an extensive network of telemedicine investigators, in-home nurses and clinical research coordinators who are connected by a purpose-built, integrated platform to orchestrate virtual trials, also known as decentralized clinical trials.
“Science 37 is already renowned for our ability to conduct fully decentralized trials in the United States,” stated David Coman, CEO of Science 37. “Now, by combining with the extensive global reach of AES, we are building on our promise to ‘make virtual the new reality’ nearly anywhere in the world.”
Of course, Science 37 isn’t alone in the market, and Pleasanton, Calif.-based Veeva Systems debuted its own personal spin on the “distancing” aspect of clinical trials in April when it announced new remote monitoring capabilities in Veeva SiteVault Free for source document review and verification in clinical trials.
“Remote monitoring supports the immediate need for sites and study monitors to continue working together while onsite visits have largely stopped,” remarked Bree Burks, vice president of site strategy at Veeva and a former clinical research director. “Veeva SiteVault Free gives sites access to remote monitoring capabilities, at no cost, so they can keep running studies and treating patients.”
SiteVault Free allows sites, sponsors and CROs to remotely manage and track the workflow and downstream processes for source document review and verification. Sites and study monitors can easily view, comment and respond to questions in a single centralized system. Reporting, dashboards and automatic notifications enable stakeholders to organize their tasks, get complete visibility into documents, and prioritize activities for immediate action.
And in a little hint that companies might want to consider the idea of remote trials at least in passing—even once the pandemic is long over—there is this commentary from data and analytics company GlobalData: “There has been an overall increase in clinical trials that have pushed back their estimated start dates since the beginning of January 2020, largely due to the COVID-19 pandemic. However, remote studies such as Heartline may have a significant advantage, as patients can continue to enroll and participate from their homes.”
As such, the Heartline trial will likely continue with minimal disruptions, predicts GlobalData. Of course, a major point of the Heartline Study—being conducted by Johnson & Johnson and Apple Inc.—was to be remote, as it aims to evaluate changes in stroke risk and atrial fibrillation detection through the use of the Heartline Study’s app and the Apple Watch.
As such, Heartline’s relatively rosy position in the current clinical trial climate was happenstance rather than design. But there might be lessons to take away, as associate pharma analyst Kajal Jaddoo of GlobalData pointed out in April that “Across various indications, clinical trials are increasingly expected to experience delays as investigators and hospitals, which are used as clinical trial sites, are inundated with COVID-19 patients. With fewer trial sites and investigators available to run the trials, clinical trials for certain indications will be deprioritized.”