The pharma unit of US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that it is embarking on a world first for the drug industry.
Janssen says that it has developed a novel mobile technology platform designed to make clinical studies more efficient and that its use of this will represent the first usage of a comprehensive technology toolset like this in a global pharmaceutical clinical trial.
The Integrated Smart Trial & Engagement Platform (iSTEP) has been developed to automate investigational product supply and data management in clinical trials and is being made available for industry-wide use through a collaboration with the Indian information technology giant Tata Consultancy Services (NSE: TCS).
Although many other pharma majors have joined up with tech companies in similar collaborations, Janssen is bold in its claims that it has an industry first that will change the way trials have been conducted for the last 50 years, replacing the paper-based conventional processes of managing clinical supplies and tracking patient health data with a cohesive suite of digital technologies.
Its platform promises to leverage mobile technology, ‘smart’ packaging and electronic labels in an effort to streamline and automate the investigational product management process in clinical trials. Smartphone apps are integrated to support patients in following their treatment schedule and interacting with their healthcare provider while participating in a study. Real-time adherence-related data is captured and delivered for patient and sponsor insight.
Andreas Koester, vice president, R&D operations innovation, Janssen, said: “As clinical trials grow in complexity, duration and cost, we are adopting different technologies to optimize 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.”
Janssen has conducted a technical pilot with iSTEP and is working with health authorities and ethics committees to implement a pilot assessment within a clinical trial by the end of the year. Thereafter the company plans to progressively implement the platform into a variety of studies that it is conducting in its portfolio.