Novartis is significantly expanding its virtual clinical trial collaboration with Science 37, planning to launch up to 10 new decentralized studies over the next three years as part of CEO Vas Narasimhan's strategy to reduce R&D costs through digital technology.
The Swiss pharmaceutical company, which was an early investor in Los Angeles-based Science 37, will implement the startup's "site-less" trial model that allows patients to participate in clinical studies from their homes using mobile devices and telemedicine services. The platform provides patients with study team notifications, remote consent forms, and mobile-based side effect logging capabilities.
Current Trial Portfolio and Future Expansion
Novartis is already conducting virtual trials with Science 37 for cluster headache, acne, and non-alcoholic steatohepatitis (NASH). The NASH program holds particular strategic importance as multiple pharmaceutical companies compete to develop treatments for this "fatty liver" disease, which represents a potential blockbuster market opportunity.
The upcoming wave of decentralized trials, expected to begin later this year in the United States, will target dermatology, neuroscience, and oncology indications. These studies will utilize Science 37's Network Oriented Research Assistant (NORA) technology, with plans to integrate the startup's enterprise software into Novartis' most critical trials.
Addressing Patient Participation Barriers
The virtual trial model addresses significant participation challenges in clinical research. According to data from the Center for Information & Study on Clinical Research Participation (CISCRP) cited by Novartis, only 2% of the eligible US population participates in clinical trials. Traditional trial participants attend an average of 11 trial site visits over six months, creating substantial burdens for both patients and research centers.
"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," said Rob Kowalski, Novartis' interim head of global drug development and chief medical officer.
Technology-Enabled Research Model
The collaboration represents Novartis' commitment to pioneering patient-centric research approaches. Evan Beckman, Head of Translational Medicine at the Novartis Institutes for BioMedical Research, emphasized the broader benefits: "Remote participation in research has the benefit of improving the breadth of participation from wider community and socio-economic backgrounds, while also allowing us to gather more meaningful real-world evidence in our clinical trials."
The virtual trial platform is designed to appeal to under-represented and underserved trial populations, potentially improving both the quality and quantity of data available during drug development. The 10 new trials will blend virtual and traditional models with varying degrees of decentralization, allowing Novartis to optimize the approach across different therapeutic areas and study requirements.
