By Allison Proffitt

October 22, 2019 | We have a problem, Bert Hartog told the audience at SCOPE Europe last month. We have huge inefficiencies in clinical trials, sup-optimal support for patients, and we aren't using new technologies the way we should. Hartog, senior director, clinical innovation, at Janssen Pharmaceutica, believes we can do better.

About four years ago, Hartog and the Janssen team began outlining a platform to solve these problems. After extensive internal needs assessment, the team set out to find a technology partner to build the platform.

"There wasn't anything available on the market," Hartog told Clinical Research News, "so we did a very comprehensive market search for the right partner to develop this platform. We were hoping to find a partner who would be able to do two things: one, build the platform, and second, take this platform into the industry for sites to benefit from what might become a standardized approach of working."

They found a likeminded partner in Tata Consultancy Services.

From the beginning the development was very collaborative, Hartog said. Janssen outlined the initial requirements, and together the partners "co-created" iStep—the integrated smart trial engagement platform. "We have done some conceptualizing, some proof-of-concept, and some technology pilots," Hartog recounts. And from there, any intellectual property that could have been Janssen's was transferred to TCS.

"Along the way there was a transition of ownership. Janssen made it very clear: we don't want to end up owning this platform, we want to be a user, because that allows [TCS] to market it to get to standardization," Hartog explained.

Janssen understands that as a sponsor it can't really drive standardization across the industry, Hartog said, but does believe they can enable an environment that allows for standardization. "We've been super transparent right from the start. We've engaged other pharma in the development process before there was a commercial solution to really make sure we didn't blindfold ourselves. I think that is a nice example of pre-competitive collaboration."

The Connected Clinical Trials Platform

Today the platform is available from Tata Consultancy Services branded as the Connected Clinical Trials (CCT) platform, with modules and offerings that extend beyond iStep. The product was recently awarded a European Innovations Award at SCOPE Europe.

CCT is a modular platform that includes what TCS and Janssen worked on together along with extended capabilities. The platform aims to empower patients, sites, and sponsors participating in a clinical trial with the power of connectivity with a variety of innovative sensors, smart medication packages and mobile devices.

The first modules cover intelligent trial medication: smart medication packaging technologies for medication adherence, electronic drug labels and automated drug accountability. They include CCT Adherence, which enables registration and verification of individual medication intake via smart packaging; CCT Label, which employs patient-specific and easily readable all-in-one electronic drug labels in the patient's own language; and CCT Tracking, which uses medication kit scanners to track all medication kit transactions at the site, and prevent dispensing errors.

Some of the CCT modules are "extremely obvious" Hartog said. Kit tracking at sites, for example, ensures that the right kit gets to the right patient, yet it is not happening often enough.

Hartog calls CCT smart blister packs, available through CCT Adherence, "quite innovative." The blister packs integrate simple electronics within the medication packaging. When a pill is pushed through the blister pack, a circuit is broken, and a time stamp is created. When you can timestamp when a medication is taken, there is much to learn, Hartog explained. "You can see how that relates to the treatment schedule. You can see patterns over time: maybe patients change during the weekend, or during the week. Behavior related to timestamps can be quite telling." For sponsors, "you no longer have to do this crazy pill counting business," Hartog said. "You've got data you can use as evidence; you can take a risk-based approach." This is just a beginning, he predicted. Soon similar tracking will be available for bottles or syringes.

Other CCT modules enable digital patient and site engagement through a bring-your-own-device patient app with multiple engagement capabilities using zero programming effort and a mobile app for sites with real time insight into patient progress and intelligent alerts. And two virtual trial modules—Digimarkers and eConsent—help facilitate direct data capture from patients and connected devices, supported by algorithms for deriving digital endpoints.

TCS designed the platform for rapid development and onboarding with a zero-programming approach. It also serves as a common platform that integrates with customer's clinical ecosystem and can be easily set up for use across a variety of studies, divergent digital adherence technologies, different wearables, biosensors and medical devices and patient engagement tools.

Janssen ran a small pilot study of the CCT patient app in 2018, and Hartog reported findings in his SCOPE Europe presentation. The study itself was terminated because of safety issues, but ten patients evaluated the app before the study ended. One subject dropped out of the pilot due to tech issues, but 60% reported overall positive patient experience. Even participants who didn't particularly enjoy having a smart phone were happy with the app. Hartog considers this evidence that even non- or low-tech using participants can use technology successfully in a clinical study.

Currently Janssen is testing the CCT patient app and site tracking modules in four existing portfolio studies that span geographies, sizes, and phases. He is already gathering data on what they are learning. For instance, there are geographic and cultural differences. Wi-Fi isn't always available in the basement where some medication storage cages are located. Some local teams prefer to double check all patient communication, and customs can be challenging. But Hartog expects long term ROI from these efforts including impacts on retention and recruitment. In every case, Hartog advises users to take time to explain the business case—the "why" behind new technologies and strategies.

Move to Market

Now as a user of the platform, Hartog says there are things on TCS's development roadmap that Janssen is watching closely, for instance, the integration of sensor data, which he says is very complex. "We are staying very close to Tata to explore opportunities for future," he said.

And he's very pleased with the success of CCT in general. Early in the development process, Janssen was particularly concerned about sites and patients and their interactions with the platform. "We were extremely aware of the potential that sites would find this yet another sponsor-driven platform amidst all the other sponsor-driven platforms and really create complexity rather than anything," Hartog explains. "From day one… we wanted to avoid unnecessary complexity for sites. For patients, [we wanted] not another point solution but find one… that will help patients feel part of the trial and not something that's just connected to the trial. Engagement is really first and foremost on the patient side."

With the award-winning commercial CCT platform from TCS, Hartog is hopeful that many others will use the platform and the industry can move toward a useful standard for sites. "Now there's a market solution," he said. "And of course every sponsor needs to decide for themselves to purchase… but at least we know from the interactions we've had that what we've developed isn't alien to many sponsor companies' way of working."