Janssen Launches First-Of-Its-Kind Mobile Medication
Janssen R&D’s iSTEP is a first-of-its-kind information technology toolset developed to automate investigational product supply and data management in clinical trials. The platform has now been launched by the healthcare giant for industry-use and is designed to replace the paper-based conventional processes of managing clinical supplies and tracking patient health data with a cohesive suite of digital technologies.
For now the technology is still at the development stage. It’s passed a technical test and Janssen aims to run a pilot assessment of iSTEP within one of its own clinical trials by the end of this year.
Andreas Koester, VP of R&D operations innovation at Janssen, said: “As clinical trials grow in complexity, duration and cost, we are adopting different technologies to optimise workflow, improve communication, and expedite data reporting, all critical success factors in clinical trials.”
“The open innovation philosophy at Janssen led us to develop iSTEP in a way that allows the technology to be available to other pharmaceutical companies. We believe that having a consistent approach across the industry can accelerate the process of bringing medicines to patients.”
“Once it ships out it is being scanned, the scanner information is fed into a central database,
” Koester said. “It’s scanned again when it arrives at the investigation site. There are solutions out there that have tackled this first scan, but we have taken it a step further because we also scan the medication when it is dispensed to the patient, which is important because it prevents dispensation errors, which otherwise almost inevitably occur.”The monitoring doesn’t stop there. The system also has several features that help make sure patients don’t just receive their medications, but actually take them.
“Once the medication gets to the patient, the patient is able, on his smartphone, to watch instructional videos, to know how to take it, with or without food, what time of the day, how to press out the blisters — all things that we know from previous investigations patients typically struggle with,” Koester said.
The smart blister packs, which interact with the same patient-facing apps, give trial investigators a way to know if medications were actually taken. (Technically all they know is that the pills were removed from the blister packs, but Koester says studies have shown this is a much better proxy for actual adherence than prescription refills.)
“We are acting right now, collectively, with a lot of imprecision when it comes to medication,” he said. “What we can do when this system is installed in all clinical trials is — because we know when the medication is taken, and the patient has via the smartphone a direct link to the investigator — we can send reminders, we can send encouragement, we can ask the patient to come back for an unscheduled visit if there are issues with the medication. All measures that overall will make it easier for patients to adhere with the prescribed schedule.”
iSTEP has four components which address these problems. The first is eTracking, which uses scanners to verify and register all medication kit activities at study sites; and eCommunication provides tailored information to patients such as reminders and dosing instructions. Meanwhile eLabel provides data in a patient’s native language in addition to information provided through booklets, and eAdherence is a set of ‘smart’ medication blister packs that register when each pill is removed.
The platform also has its own smartphone app to help patient follow their treatment schedule and interact with their healthcare provider while part of a clinical trial.
So far Janssen has tested iSTEP in a technical pilot of 24 healthy volunteers of a mixture of ethnic backgrounds. The platform produced a compliance rate of 92% and a satisfaction rate of 84%.
