UCB announced it will work with Science 37 to bring clinical trials out of brick-and-mortar research sites and into participants’ homes. By using telemedicine, real-world data and outcomes reported by patients via a mobile device, they plan to ultimately make certain types of studies much more feasible.
The pharma company plans to initiate its first trial employing Science 37’s decentralized, siteless model later this year to evaluate its Neupro patch in pediatric restless leg syndrome, following its approval for adults. Participants will track their sleep, the impact of the disease and their overall quality of life using a smartphone app, with the drug and other study materials delivered through the mail. The trial plans to enroll at least 138 patients, aged 13 to 17, from across the U.S.
“If we pursued this study in the traditional model, it would probably have been impossible to identify and engage patients and their parents appropriately,” said Iris Loew-Friedrich, UCB’s chief medical officer.
The company projected it would take seven years or more to accrue the necessary number of patients, all of whom would have to live within reach of an investigative site.
“This is a patient-focused revolution in the way we operationalize clinical studies,” Loew-Friedrich told FierceBiotech. “It’s an opportunity to turn a ‘mission impossible’—mainly fulfilling the pediatric requirement for Neupro—into a very realistic and meaningful opportunity, on top of providing a very positive experience for patients."
“We think of ourselves as a giant site without borders,” said Science 37’s co-founder and chief medical officer, Belinda Tan, who described how enrolled patients could use the smartphone app—Network Oriented Research Assistant, or NORA—to contact the company's study investigators and schedule video conferencing on their own time.
“Young individuals have lives, or they’re going to school, or going to college,” Tan said. “Certain types of patient support, from a customer-service point of view, for us includes being very available throughout the day, during afterschool hours or weekends—unlike what is available in a traditional clinical trial.”
Other initial studies in the partnership will focus on neurology and immunology, but UCB may not stop there.
“In our efforts to really enhance the patient experience, we’re currently looking at all our upcoming studies to identify the candidates that are fit for this model,” said Loew-Friedrich. “We’re really trying to move our clinical operations approach toward virtualization and towards our partnership with Science 37.”