Covance, the drug development business division of LabCorp, announced it is working to expand its technology offerings with solutions intended to speed the industry adoption of decentralized and hybrid trials. The company plans to partner with Medable, a provider of software for digital clinical trials.
Conventional challenges
Bill Hanlon, president of enterprise solutions with Covance, told Outsourcing-Pharma that conventionally structured, ‘brick and mortar’ trials create a number of potential obstacles for participants, which leads to negative impacts on the trials themselves.
“The traditional clinical trial model relies on investigator sites to identify patients to participate, and then requires those patients to travel an average of 25 miles each way on a regular basis for procedures at investigator sites,” Hanlon said. “As a result, less than 5% of potential patients participate in clinical research.”
What’s more, Hanlon told us, potential patients who aren’t aware of the options available to them in the trial realm never hear of the opportunities, or they cannot travel the long distances required due to work, illness, family obligations, and other hurdles.
“A stunning 85% of clinical trials miss enrollment timelines,” he explained.
Industry evolution
However, Medable’s head of decentralized trials Alison Holland points out as virtual and decentralized trial technology has evolved, acceptance has increased.
“With the increasing use of mobile phones and wearables in digital trials, the patient-centric aspect of these new trials will make it easier to recruit and retain patients and accelerate clinical timelines as well as open the door to patients who would otherwise live too far from a clinical site to participate,” she said. “Digital trials offer custom and off-the-shelf capabilities to support the most complex trial protocols with virtual visits, from scheduling to conducting the visit.
COVID-19 impact
Hanlon also explained the current COVID-19 pandemic has rapidly accelerated the build-up of interest in decentralized trials, and the drive toward adoption of the technology, and he believes the trend will continue, thanks to newly created obstacles.
“In some communities, healthcare resources have been significantly diverted to treating COVID-19 patients,” Hanlon explained. “In other locations, regional authorities have discouraged people from going to a hospital unless it is COVID-19 related or another emergency situation, or patients may be reluctant to come into a hospital or doctor’s office for a routine study visit.”
Additionally, Holland explained COVID-19 has created needs and opportunities regarding patient experience and development of therapies.
“There is an immediate opportunity for decentralized trials and creative digital solutions to improve patient access, experience, and outcomes,” she explained. “Working together as a community to drive forward faster, whether it’s streamlining trials for COVID-19 vaccines, reducing timelines for other therapies, or initiating new trials to address the 7,000 rare diseases that have no therapies on the market.”
Parnership details
According to the companies, the Covance patient and site interface will be powered by Medable’s modular software platform. The platform is engineered to provide immediate access to applications empowering patients to participate in trials remotely; it also reportedly will increase data/system interoperability, enable remote data collection, and increase engagement between patients, sites and investigators.
“Medable will supply the data and application platform that includes patient, site, and sponsor-facing tools that enable functions such as eConsent, ePROs, eCOAs, IRT, reminders, and a host of additional features,” Hanlon added. “This includes capabilities supporting telemedicine, mobile health, wearable data collection devices, patient service center scheduling, and other remote functions.”
Covance is a participating company at BIO Digital. For more information, click here.
