Johnson & Johnson’s pharmaceutical division Janssen has developed a new mobile clinical trials platform to streamline clinical supply management and potentially improve patient reporting and medication adherence in these studies. The Integrated Smart Trial & Engagement Platform (iSTEP) incorporates multiple tools which also have the potential to reduce the cost of clinical trials.
“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,” said Dr. Andreas Koester, Vice President, R&D Operations Innovation at Janssen. “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.”
According to Janssen, a combination of four components, which take advantage of tools such as mobile technology and smart labels, make up the iSTEP platform. While designed to be used together, these tools can be use in isolation depending on the needs of the clinical program.
The company’s eAdherence piece monitors medication adherence using blister packs capable of detecting and digitally recording when a pill is removed. Janssen says this functionality could allow healthcare providers and study staff to intervene with participants in real-time if they show a pattern of deviation from their medication schedule.
eCommunication provides custom information to each patient via their smartphone, such as reminders and videos on how to take their medication. This system also allows users to report any adverse events.
On the study coordination side, eTracking allows study sponsors and physicians involved in the trial to monitor distribution of the medication kits, which could reduce the risk of dispensing errors. Finally, the eLabel component allows study staff to present study information in the patient’s language, and allows for easier updates and changes to these materials once the trial has commenced.
“After testing the usability of the iSTEP technology, I believe it can improve the efficiency and proficiency with which we conduct clinical trials at our site; creating more time to engage our study participants at each visit,” said Dr. Leonard Chuck, Medical Director, Diablo Clinical Research, Inc.
While the iSTEP system has so far only been assessed in a pilot program, Janssen plans to use the platform in a clinical trial before the end of the year. Provided health authorities and ethics committees approve the use of the iSTEP program, Janssen will begin to use the mobile tools in some of its upcoming studies.