Novartis Expands Virtual Clinical Trial Project with Science 37

Richard Staines, pharmaphorum news

March 7, 2018

New CEO Vas Narasimhan wants to cut Novartis’ R&D costs by using digital tech – and with this in mind the firm has scaled up a project involving virtual clinical trials.

The Swiss pharma company is to begin up to 10 new trials with Science 37, which is pioneering a ‘site-less’ trial model, over the next three years.

Novartis was an early investor in LA-based Science 37, which has developed technology allowing people to take part in clinical trials from their own homes via mobile devices and other telemedicine services.

It provides them with reminders and notifications directly from the study team, allows them to connect at any time and fill in consent forms remotely. Possible side effects can be logged using mobile devices.

Novartis said the 10 new trials will blend virtual and traditional models with increasing degrees of decentralisation.

The pharma company is already working with Science 37 on virtual trials for cluster headache, acne, and non-alcoholic steatohepatitis.

The latter is very important for Novartis as a number of pharma companies are trying to find drugs to treat this “fatty liver” disease, which could lead to blockbuster-level sales.

A new wave of decentralised trials is expected to begin later this year in the US in dermatology, neuroscience, and oncology.

They will use Science 37’s Network Oriented Research Assistant (NORA) technology, and through the alliance the companies plan to apply some of Science 37’s enterprise software to some of Novartis’ most important trials.

Novartis also hopes that the new clinical trial model will appeal to patients too. It cited data from the Center for Information & Study on Clinical Research Participation (CISCRP), showing only 2% of the eligible population in the US participate in clinical trials.

Those who do participate attend an average of 11 trial site visits in six months, representing a significant burden for both patients and trial centres.

It also hopes that the approach will appeal to under-represented and underserved trial populations, improving the quality and quantity of data available during drug R&D.

Novartis’ interim head of global drug development 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.”

Evan Beckman, Head of Translational Medicine at the Novartis Institutes for BioMedical Research, said: “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.”

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