Normally, you’d think of Janssen as the sponsor of clinical trials, assigning study tasks to contractors, but the Johnson & Johnson pharma unit has taken the opposite role as a service provider, having developed a mobile app for trial supply management and patient engagement that can track medication adherence to each pill.
“While there are many standalone solutions available, we saw a key need for a comprehensive, mobile toolkit with the ability to address two key pain points in clinical trials: investigator administrative burden and providing better patient information and adherence support,” Andreas Koester, M.D., Ph.D., vice president of R&D Operations Innovation at Janssen, said in an emailed interview with FierceCRO.
Indeed, there are many randomization and trial supply management (RTSM) solutions out there, why does Janssen call its new Integrated Smart Trial & Engagement Platform, or iSTEP, a “first-of-its-kind information technology toolset”?
Janssen developed the platform in collaboration with Tata Consultancy Services as part of the latter’s Connected Clinical Trials platform. It consists of four modules, which can be used independently or together.
First comes eTracking, which uses scanners to track medication kits, from arrivals to allocation and dispensing to returns. This component definitely helps make site staff’s work easier, but a few months ago, Parexel has already launched a mobile app called ClinPhone with almost exactly the same barcode scanning and tracking feature.
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Koester said it is iSTEP’s patient engagement and intake monitoring elements that make it special.
An eCommunication module provides information such as reminders, dosing instructions and tutorial videos, tailored to patient needs. The communication is actually going in both ways as the module will also collect certain data from patients, such as adverse events.
The eLabel function can customarily distribute electronic drug labels, together with other patient-related data, in the patient’s desired language. It is also designed to be flexible, as it can update trial protocol and inform patients even after the trial has started.
But perhaps the most “smart” part of the platform is eAdherence. Drugs are put in blister packs that automatically register each pill as it is removed. Janssen said such close monitoring of adherence may enable real-time intervention.
Before rolling out the final product, to evaluate the effectiveness and user-friendliness of the platform, Janssen has already tested a prototype in a technical pilot conducted in Belgium that enrolled 24 healthy volunteers of different age groups and who speak three different native languages. The pharma company reported that the compliance rate reached 92%, and said in an introductory piece that the pilot “verified that all of the iSTEP components worked in an integrated manner.”
Koester told FierceCRO that the company is planning to deploy the platform in a phase 2 trial in 2017, and said that feedback from health authorities regarding the use of iSTEP “has been very positive and encouraging thus far.”
“We envision this platform will become the backbone and integrating component for many of the currently available and future clinical trial applications,” he said.
The iSTEP platform is actually not Janssen R&D Operations Innovation’s only clinical trial program. It also has a tablet-based electronic informed consent solution that provides interactive, multimedia educational materials for prospective clinical trial participants. It is also carrying out two patient-centered initiatives that allow either patients’ perspectives into trial design or their access to routine lab data to be collected in clinical trials, all for better enrollment, engagement and retention.