The trials will be a mix of virtual and traditional models and will have increasing degrees of decentralization towards a largely site-less model.
With decentralized or virtual trials that are monitored using digital technology, some or all aspects of a clinical trial can be held at a participant's home or local physician's office. Thereby, drug makers can avoid a central trial site like a large hospital for their clinical trials.
Novartis plans to begin its new decentralized trials later this year in the US in the areas of dermatology, oncology and neuroscience.
Science 37's NORA technology facilitates patients’ participation in clinical trials, irrespective of their geographical location, by using mobile devices and telemedicine services.
Novartis global drug development ad interim head and chief medical officer Rob Kowalski said: "Novartis aims to run studies in ways that overcome many of the barriers patients face when deciding whether or not to enroll in clinical trials, like long journeys or extensive time spent at hospitals or trial sites.
"With our shared vision of futuristic trials enabled by technology, we're excited to expand our collaboration with Science 37 to pioneer a new, patient-centric research model."
The new agreement builds on Novartis’ investment in and collaboration with the Los Angeles-based Science 37 to deploy emerging digital technologies to improve clinical trial participation for patients.
Through its partnership with Science 37, Novartis had already commenced virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH).
Science 37 co-founder and CEO Noah Craft said: “We are excited to deepen our relationship with an industry leader in innovative drug development like Novartis. As one of our earliest investors and supporters, their senior leadership recognized the value proposition of our NORA technology platform and ‘siteless’ clinical trial model.
“We are thrilled to launch this strategic alliance to accelerate our patient-centered scientific work together across these new therapeutic areas.”
Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.