Clinical Trial Collaboration
Novartis Research Is Going Digital
The major drug manufacturer Novartis intends to expand its use of the Apple Research Kit (ARK) software in its clinical trials, according to Andrew McConaghie, writing in Pharma Phorum. This could increase the involvement of digital technology in all drug research and development.
It is hoped that going digital will lead to larger subject groups, recruited more easily thanks to the convenience of remote monitoring, and to lower costs for conducting clinical trials altogether. Most big pharmaceutical companies have made the investment in digital technology in order to open up clinical trials to more patients via remote monitoring technology.
Jacob LaPorte, head of digital development for Novartis, said, “What we’re doing is changing our culture right now. Our aspiration is to become a medicines and data science company. We think a cultural change is going to be required to do that, and we are heavily focused on becoming more agile and better able to relate to our partners.”
The Apple Research Kit is a software platform that enables subjects to input their own data at a distance, using sensors that record and transmit multiple forms of data. The digital smartphone research platform enables study participants to contribute to research from home or on the go. At the same time, it allows for researchers to collect data in the participant's everyday environment. Novartis is using ARK in its ELEVATE MS study, as well as in a feasibility trial for another disease. Increased adoption of the ARK by Novartis would be a big boon for Apple’s objectives in clinical trials, where it is competing with many other technology companies, many of them specialists in the clinical trial field.
ARK has not been used on the scale that Novartis proposes, so preparatory work will have to be done. La Porte said, “We have got to build functionality, so they [Apple] know that, we know that, we are going to make the investment. But I think it could be big.”
“Wearables,” digital remote sensors that report data while the subjects go about their day, are now being used in the AWAKE-HF trial that is investigating the effects of the heart failure drug Entresto, made by Novartis, on patients’ behavior and sleep. However, this study does not involve the use of ARK.
Novartis is also partnering with Science 37, another company working in mobile technology for trials, and Qualcomm to create a digital version of its Breezhaler inhaler for COPD.
Novartis International AG, a Swiss multinational pharmaceutical company based in Basel, Switzerland, is one of the largest pharmaceutical companies in terms of market cap and sales. Its products include the drugs clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), ciclosporin (Neoral/Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil) and others. In 1996, Ciba-Geigy merged with Sandoz, and the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity at that time.