Running clinical trials is an expensive business and Novartis has signed a new deal with US tech company Science 37 to try to take some of the costs out of the process.
The aim is to expand the number of ‘virtual’ trials it runs, with patients interacting with investigators via mobile phones and telemedicine devices rather than attending investigation sites in person. It’s not a new concept – Novartis already has virtual trials ongoing – but the deal with Science 37 for ten trials over the next three years signals greater acceptance of the approach.
It’s a gradual process, and Novartis says the studies will “blend virtual and traditional models, with increasing degrees of decentralisation towards a mostly ‘site-less’ model”. This could allow trials to dramatically increase the pool of patients they can draw upon as they can now participate at their home or via their own doctor’s office.
Under former R&D chief and now CEO Vas Narasimhan, Novartis has long been a devotee of using technology to help the clinical trials process, medical education and healthcare delivery become more efficient.
In 2015 for example the company formed a wide-ranging alliance with tech giant Qualcomm to move towards greater use of digital devices in clinical trials, and it has also been active in making venture capital available to players in this sector – in fact it took a 10% stake in Science 37 after participating in the firm’s third-round financing last year.
Novartis says the new decentralised trials are expected to begin later this year in the US in the areas of dermatology, neuroscience and oncology. It’s already running semi-virtual trials for non-alcoholic steatohepatitis (NASH), acne and cluster headache.
According to the Center for Information & Study on Clinical Research Participation (CISCRP), only 2% of the eligible population in the US participate in clinical trials and 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.
“In our experience to date, we have been impressed with the recruitment in the virtual trial setup and believe for many patient populations this will be superior to traditional hospital or clinic sites,” said Evan Beckman, head of translational medicine at the Novartis Institutes for BioMedical Research.
“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,” he added.