Addressing Administrative and Adherence Burdens in Clinical Trials

In early October, Janssen Research & Development, LLC announced the Integrated Smart Trial & Engagement Platform (iSTEP), a first-of-its-kind information technology toolset developed to automate investigational product supply and data management in clinical trials (read here). Developed by Janssen, in collaboration with

Andreas Koester

Tata Consultancy Services (TCS), the tool is available for industry-use and is designed to replace the paper-based processes of managing clinical supplies and tracking patient health data with a cohesive suite of digital technologies. 

In the Q&A ahead, Andreas Koester, MD, PhD, Vice President, R&D Operations Innovation at Janssen, discusses iSTEP, the platform’s history, and its future potential.

Q:When did you start developing the iSTEP Platform with TCS and what precipitated that idea?

KOESTER: Janssen began exploring a digital platform for medication management and patient engagement more than five years ago. At that time, we realized while there were many standalone solutions available in the marketplace-smart bottles, smart blisters, medication scanners-we were missing a comprehensive, mobile toolkit with the ability to address two key pain points in clinical trials: investigator administrative burden and patient information/adherence.

We started interactions with TCS on iSTEP toward the end of 2014. They are a leading global IT services, consulting, and business solutions organization with a very strong IT business. We had confidence in their technology prowess and experience in clinical trial IT to collaborate with us and build such a platform. 

Q:This is not related to TransCelerate, but you encourage other pharma to adopt for a consistent approach across the industry. How are you doing that?

KOESTER: The open innovation philosophy at Janssen led us in collaboration with TCS to develop iSTEP in a way that allows the technology to be adopted by other pharmaceutical companies. We believe that a consistent approach across the industry can accelerate processes to bring medicines to patients faster, and at a lower expense. 

We’ve proactively engaged a number of companies and informed them about the platform in December 2016 and held a readiness meeting in June 2017. At the meeting in June, we presented the platform to 26 R&D leaders of eight global pharmaceutical companies, and many expressed interest. 

Q:Is this a cloud-based approach?

KOESTER: Yes, similar to many other eTechnologies services like electronic data capture (EDC) systems, etc.

Q:What were the challenges and benefits you learned in the pilot?

KOESTER: A core challenge was that this was a huge development with many different system and device integrations, which is always a challenge and a big reason why so little actually had been done across the industry to that point. 

We learned that site personnel, sponsor personnel, and participants were overall very positive about their experience with the smartphone and smart blister. We received enthusiastic feedback on the platform’s usability and remote-monitoring capabilities. The pilot also verified that all of the iSTEP components worked in an integrated manner.

Q:What feedback have you had from the regulatory authorities as you attempt the tool’s use in a clinical trial?

KOESTER: Feedback to date from regulatory authorities has been very positive. We do expect to have all necessary approvals to begin using iSTEP in a study by the end of the year. 

Q:Can you share the size/phase and TA of the intended trial?

KOESTER: We plan to implement iSTEP in a Phase II trial by year’s end, and don’t have additional information that we can share at this time.

Q:Are there any plans to expand iSTEP into other clinical trial operation aspects?

KOESTER: Yes, we are always exploring new opportunities to expand iSTEP and reduce the complexities of clinical trials with the benefit of patients and investigators in mind. To this end, we see the iSTEP platform as the backbone for future utilities to be added, e.g., eICF, ePRO, sensor data feeds. We are on an exciting journey.