- RWD can support and improve randomized clinical trials that struggle to find enough patients or need to test a hypothesis before a full launch.
- Decentralized trials make it easier for patients to participate in studies — especially during COVID-19 — and for researchers to follow up on long term outcomes.
- Diversity in hiring practices and sources of inspiration helps your company innovate in unexpected and rewarding ways.
The impacts of a pharmaceutical company’s digital and data team on patient care can seem less consequential compared to the work that goes on in the lab.
But technology and data collection are being used at all stages of treatment to improve patients’ experiences and outcomes.
Pharmaceutical company Novartis is using real world data to support clinical trials, track patients’ progress on specific medicines, and improve decentralized trials just as COVID-19 has made remote medicine essential.
In an episode of the “Real World Talk” podcast, Bruno Villetelle, Global Head of Data and Digital for Novartis, discusses the ways real world data can support randomized clinical trials, improving treatments with technology, and why taking the trial from the lab to the patient is vital in the age of COVID-19 — and beyond.
RWD Can Support Clinical Trials
Randomized clinical trials remain, as Villetelle notes, “the gold standard” when it comes to gathering efficacy and safety data on medical treatments in development. But real world data can provide invaluable insight to support that research.
“Real world data can complement typical development programs by informing the selection of endpoints, the design, and recruitment of studies — which can potentially accelerate timelines, reduce clinical trial costs, and increase the probability of success,” Villetelle says. Novartis is already working with COTA, “to evaluate the feasibility of your real world data to optimize and develop programs and accelerate access, and potentially optimize medical practice,” he points out.
In circumstances that make randomized clinical trials difficult, real world data can help fill in the cracks. For example, in a study with patients whose cancer was caused by a very rare mutation, real world data was used to compare against data gathered from a single-arm Phase II trial testing a medical intervention. “These data can provide a benchmark comparison to support regulatory decision-making and reimbursement,” Villetelle says.
Using Technology to Improve Patients’ Experiences
Digital and data technologies can have a direct impact on patient care. Villetelle explains that Novartis’s data and digital ambitions are consolidated into three aims: bringing medicines to twice as many patients two years faster for a better cost.
“We are tackling that from two sides,” he says. “One is to keep working on how technologies can help us reinvent methods of developing drugs. And we’re also looking into how specific medicines could benefit from technologies beyond the current process.”
For example, Novartis is investigating the use of an immunosuppressant therapy that can help prevent organ rejection in transplant patients. The data and digital team is helping in three ways. “We are using a machine learning-enabled surrogate endpoint to predict long term graft survival,” Villetelle says. “We hope this will help us shorten clinical development by up to three years.”
Second, he says, patients are fitted with sensors that monitor, “cognitive impairment, tremor and sleep disturbance in transplant patients treated with the current standard of care.” And finally, “we are using smart drug delivery devices to improve the experiences of the patients.”
Decentralized Trials are More Relevant Than Ever
Villetelle describes Novartis’s work on decentralized trials (DCTs) as, “a topic that’s very close to my heart.” Using its own and its partners’ technology, Novartis has been developing methods to help take trials to patients, instead of the other way around.
“Our focus is to enhance the patient’s experience using solutions such as telemedicine, mobile nursing and direct-to-patient investigational medication delivery,” Villetelle says. He adds that Novartis has implemented DCTs in several pilot studies, some ofwhich even involve interventions from researchers. The plan is to use digital technology to keep following up with patients after the initial study is complete. “This means at the end of the day, decentralized clinical trials will span the entire life cycle of drug development,” he says.
Not surprisingly, COVID-19 has accelerated the need for carefully conducted and reliable long distance research. “These difficult times reaffirm the role of these technologies and services,” Villetelle says.
“We aim to continue our conversations with regulators to further explore opportunities to implement a decentralized clinical trial model. We are now truly scaling the new data and digital-enabled model of drug development. I think we can say that we have moved from myth to value.”
Diversify Your Reference Points
Innovating processes that have been set in stone for decades requires flexible thinking — which is why Novartis makes an effort to look at other industries for ideas.
For example, Villetelle and his team looked to the build-operate-transfer model used in many public-private partnerships for inspiration when it came to working out how to incorporate new technology into their existing processes.
When the data and digital teams build something new, they initially operate it in isolation until it meets a set of predetermined criteria that confirm it’s ready for a wider release. “And then we transfer it to the business to become a new normal,” Villetelle explains.
This openness to outside experiences and expertise explains why Novartis aims, as Villetelle says, “to become the number one partnering ecosystem.” And it extends to its internal hiring practices. As a sponsor of the company’s diversity and inclusion movement, Villetelle says, “I am a firm believer that diversity is essential to innovation.” Bringing individuals together who have “unique cultural and experiential backgrounds” puts them “in the best environment to thrive.”