Janssen iSTEP is designed to improve medication adherence for clinical trials and make them cheaper to run.
In what could be a milestone development for clinical trial design by big pharma companies, Janssen, which is the pharma arm of Johnson and Johnson, has unveiled a set of tools to automate investigational products and data management in clinical trials, according to a news release. The goal is to improve medication adherence across multiple trial sites in different countries.
The Integrated Smart Trial and Engagement Platform, or iSTEP has a few components. Connected medication blister packs note when each pill has been taken. Electronic drug labels make it easier to convey medication information in the participant’s language. Another component, eCommunication, makes it easier to customize information to individual trial participants. Videos and patient notifications can be conveyed via smartphone.
Close up of connected medication blister pack for iSTEP from Janssen.
Janssen’s iSTEP is the product of a five-year quest by the drug developer to produce a platform that supports medication management and patient engagement. A pilot to evaluate iSTEP’s remote monitoring capabilities included 24 healthy volunteers varying in age from 18 to more than 65 years old with a mix of Dutch, French, and English speakers.
It produced a compliance rate of 92 percent with 84 percent saying iSTEP was easy to use.
Dr. Andreas Koester, Vice President of Innovation with Janssen Research and Development Operations, said in response to emailed questions that Janssen developed iSTEP in collaboration with Tata Consulting Services. Tata is also responsible for licensing iSTEP to biotech and pharma companies and other businesses interested in using it.
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Koester said iSTEP has a web portal and an app. As the platform evolves, he said more interaction modes will be added.
“A key feature of the platform is its ability to easily interact with existing and future systems and technologies, such as electronic patient-reported outcomes, eConsent, and sensor data,” he said “To our knowledge, there are no other platforms available with similar functionality to iSTEP, which was a major driver in our decision to develop this innovative solution in coop with TCS.”
