Stephen Voice (left) and Robert McGregor during the opening of the SENSE center on the Campus in Basel.
Published on 01/07/2020
Every year, Novartis conducts close to 500 clinical trials around the world, each involving global and local organizations, clinical supplies, site staff, physicians, and, of course, trial participants. With so many moving pieces, it is a formidable task to maintain an overview of end-to-end clinical trial activities, let alone manage risks proactively before they become issues.
“It used to be this tortuous review of pyramids of spreadsheets to obtain the country, region, and global status of a clinical trial – all data being cut at different time points, coming from different systems, and considering different assumptions and rules,” says Stephen Voice, Global Head, SENSE & Bridge CoE. “Discussions were often derailed, and teams only realized the real issues once we stumbled across them and it was too late.”
Issues can arise anywhere along the clinical trial lifecycle, but these layers upon layers of spreadsheets made it difficult to have a clear and comprehensive view of how any given trial was progressing. As just one example of the types of challenges that clinical teams face, newly set-up trial sites sometimes struggle identifying and enrolling potential participants – delaying the trial from the very outset.
Such things are now a thing of the past. SENSE now highlights all irregular situations. In one instance, Stephen Voice and his team observed that for one trial in China nearly 30 percent of new sites had yet to screen a single patient, despite being open for more than 30 days. The situation on the ground was remedied quickly.
SENSE now makes all of this clinical operations data transparent and readily available to the clinical teams. In addition, it provides data-driven predictions, enabling teams to remediate risks before they emerge. Thanks to the information provided by SENSE, the trial manager was able to identify which sites needed support and remotivation, helping reduce the number of non-screening sites down to 12 percent in only six months.
“Before this transparent data and SENSE, it might have taken six months to even know about the issue, or we might never have seen those results,” says Voice. “Today we have that information right at our fingertips and, thanks to SENSE, we now have trials where we’re actually ahead of plan and end the trial early.”
The heart behind it all
In 2017, SENSE was originally conceived as the Study Operations Center – like an airport traffic control tower. The vision was that this center would enable clinical trial managers to have end-to-end trial overview, with SENSE providing data-driven insights and predictions regarding potential risks throughout trial conduct.
At that time, the proposal was so ambitious and technologically sophisticated that the team jokingly compared it to Tony Stark’s personal artificial intelligence computer, JARVIS, from the Iron Man movies. Despite starting off as a joke, the analogy stuck with the team and actually shaped a number of graphical design components in SENSE (the study overview radial looks very similar to the arc reactor that powers Tony’s suit).
“That mantra has stayed with the team ever since day one,” says Voice. “SENSE has to be something above and beyond anything attempted before – and that’s what we’ve built.”
Since those early days, the concept has evolved into both a physical headquarters, “The Bridge,” and the SENSE application, which enables clinical teams to have end-to-end trial overview on their laptops, phones, or tablets. With a few clicks, trial managers can now quickly switch from global trial overviews to the detailed operations of a single site – and everything in between. “SENSE can tell us for every single trial how we’re doing,” explains Voice. “It’s also starting to really intelligently identify where activities occur in the wrong chronological order and where we’re missing data.”
