Home “became the new trial site” last year for Novartis, which has around 500 clinical trials ongoing at any given time, with about 100,000 patients in 20,000 sites across 60 countries. With such a large operation, the challenge to respond to the impending pandemic in 2020 was tremendous.
“From our perspective, when we noticed COVID start to happen, clearly, given the scale, we wanted to quickly go into measures and [determine] how we can handle COVID,” said Badhri Srinivasan, head of global development operations.
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Planning began before the pandemic was even declared. Novartis set up a “COVID SWAT” team and other governance structures that could anticipate the impact of the virus emerging from China. Once the true danger of the virus became all too clear, Novartis kicked its plan into place.
Safety of the Swiss pharma’s own staff, the clinical investigators and the patients was the first priority. Then, Novartis worked to ensure the integrity of the trials was not compromised as the company figured out new ways to continue collecting data. All decisions were made “in 24 hours or less” because of the shifting information on COVID-19 and the spread of the virus, according to Srinivasan.
“Rapid decision-making was one of the things that we wanted to make sure does not get in the way, that there's no bottlenecks, there's no unnecessary hold-up,” Srinivasan said.
Novartis’ clinical program went virtual, including site visits with investigator contacts, and the company redeployed technology to ensure the existing infrastructure could meet the challenge.
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To ease the burden on patients, Novartis began mailing medications and doing home nursing care—a risky bet that had always been off-limits. The company created internal guidance documents to ensure the trials were following good clinical practices and keeping patients safe.
Thousands of at-home visits
Novartis ramped up from zero remote monitoring visits to 55,000 conducted in 2020. Nursing care was offered across nine countries.
More than 3,000 medicine shipments went out directly to patients’ homes, and it wasn't as simple as dropping a bottle of pills in a box and sending it on. Srinivasan said at times people on the ground had to work with embassies to ensure patients could get their medication.
While some of these virtual applications could reduce costs for companies, Srinivasan said the “extra white glove service” of home nursing offset those savings.
“We obviously didn't do it for the cost savings. We did it to make sure that we minimized the disruption [and to] do the right thing by our patients and investigators,” Srinivasan said.
The bigger benefit is that Novartis got to keep developing medicines in an unprecedented year with minimal disruption.
“We were able to maintain continuity of operations, trial integrity [and] meet our trial commitments 95%,” Srinivasan said.
Novartis had to beef up its technological capabilities to make the entire transition happen, so the new R&D methods—although launched quickly—are now permanent, according to Srinivasan. That means the new norm will include remote monitoring visits, virtual site startup, direct-to-home medicine shipments, telemedicine and managing the patient experience.
“We ask patients to come in when they have to—maybe there's an oncology infusion that's coming—but if there are follow up visits, [it’s] absolutely fine to stay at home,” Srinivasan said.
This all goes into a new focus for Novartis: the “rise of the patient as a consumer,” he added.
“Patients expect more, want more. [They] want to be treated as a consumer, not as a patient, and want an experience that is, frankly, better than just contributing data to a trial,” Srinivasan said.
"Just in case" delivery
Novartis also removed red tape and placed decision-making power in the hands of people closest to the research, instead of layering those decisions through steering committees.
Novartis executives or decision-makers back at a corporate office just couldn’t do everything that had to be done to make the trials happen. They had to trust people on the ground. For instance, Srinivasan remembers people in the countries running trials stepping up to work with embassies to ensure medicine shipments could happen on time even though borders were closed.
“When we actually trusted our people and allowed them to make decisions, we saw absolutely amazing things happen,” Srinivasan said.
Before the pandemic, a big trend in business was “just in time” delivery, a theory that labor, materials and goods are scheduled to arrive exactly when they are needed. But COVID-19 blew that up.
“If [we] want to disruption-proof our operations, then we have to do just in case,” Srinivasan said. He cites a study from consulting firm McKinsey that says companies should expect a major disruption to their business every 3.7 years, on average. “We will invest and make sure that risk management is something we follow,” he added.
Another thing Novartis has learned is not to wait for guidance from regulatory agencies, but to instead inform policy changes as needed. The FDA took feedback from the industry and watched as companies figured out a path through the pandemic, using all that information to shape its ongoing guidance.
“We used to wait for guidance documents from the various regulatory agencies,” Srinivasan said. “COVID taught us that we don't need to wait. We can take the lead and do things the right way.”