Interview – Novartis goes all in on digital trials

Since being named Novartis’s chief executive last year, Vas Narasimhan has talked a lot about the importance of digital technologies in the pharma world. The group confirmed its commitment to the so-called digital revolution with two deals in the sector this month, partnering with Science 37 in remote clinical trials and Pear Therapeutics in digital therapies.

Still, there are inherent risks in investing heavily in a nascent field, and forays by other healthcare companies into IT have not always gone smoothly. Novartis’s head of digital development, Jacob LaPorte, admits that the group’s current projects might not all succeed, but he believes that this is part of the process.

“Some of these things may not work out, but we might be able to learn from those failures and be able to change our approach,” he tells EP Vantage.

Mr LaPorte believes that the risk is worth it because there are fundamental problems with the way drug development is carried out today. Novartis wants to change current thinking with the Science 37 agreement, which will test a “siteless” clinical trial model.

Speeding up

The idea is that bringing clinical trials to patients, instead of expecting patients to travel to trial sites, should speed up enrolment and reduce dropout rates, making drug development quicker and cheaper overall.

“The cost of bringing drugs to market is going up exponentially,” Mr LaPorte says, adding that much of this is down to inefficiencies in the conventional clinical trial model.

“We know that nearly 80% of clinical trials experience some delay, often due to issues recruiting patients. We know that, on average, 30% of patients drop out of clinical trials. And overall only 2-4% of eligible patients are able to participate in clinical trials.”

Mr LaPorte believes that, so far, the pharma industry has only tinkered around the edges of the traditional model, to little effect, whereas Novartis is pushing for a “complete shift” away from the current paradigm.

Ultimately, Novartis’s aspiration “is to be able to launch some form of decentralised trial in any part of our portfolio where it makes sense”, he says, and the Swiss company is already looking at more potential partners in the space.

For now it is focused on Science 37’s Network Oriented Research Assistant (NORA) technology, which allows patients to participate remotely in studies using mobile devices and telemedicine services.

Novartis, through its “innovation engine”, NIBR, has already worked with Science 37 on early studies, but the latest agreement has been expanded to include larger phase II and III trials.

Dermatology, neurology and oncology

Novartis will initially evaluate the remote trial model in dermatology, neuroscience and oncology.

Within neurology, Mr LaPorte highlights cluster headache as an area of particular interest: “Often protocols say when you have a headache come into the research site, but sometimes people are almost incapacitated, so how are they supposed to get to there?”

However, decentralisation will not be suitable for every trial, including those using sophisticated imaging that needs to be done at a research site or those in diseases that require hospitalisation.

As well as potentially improving efficiency, the decentralised model could increase diversity by capturing patients unable to enrol into conventional studies, such as people living in senior care facilities, Mr LaPorte says.

Although Novartis is convinced of the promise of remote trials, other efforts with telemedicine have not always worked out. Notably, Philips’ landmark UK Whole Systems Demonstrator (WSD) study found that telehealth was not more cost effective than standard of care in chronic conditions like heart failure. Still, the WSD was in a general care setting rather than a clinical study.

Mr LaPorte says preliminary data with a decentralised trial model have found a “severalfold increase in recruitment rates” and that a reduction in costs, while less important, should follow. It will be some time before Novartis can answer the question of whether remote studies are indeed more efficient than conventional ones; the company needs to do some feasibility work before starting its first siteless trial under the new agreement later this year.

Novartis’s other recent digital deal, with Pear Therapeutics, is at an even earlier stage. The Swiss group’s NIBR division will test Thrive, a cognitive behavioural therapy app developed by Pear – which will be regulated as a medical device – in schizophrenia and multiple sclerosis.

Mr LaPorte admits that Novartis’s digital efforts are still embryonic, but says the company hopes to become a leader in this field. Other groups including Sanofi and Otsuka have also partnered with Science 37, but Mr LaPorte says: “I don’t see anyone that has that type of commitment at the scale we do.”

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow @ByMadeleineA on Twitter