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Janssen develops digital tools to help automate clinical trials

iSTEP platform combines mobile tech and smart packaging

Janssen scientists.

Janssen’s US research and development operations have developed a first-of-its-kind toolkit combining mobile technology and smart packaging for the paperless tracking of patient health data.

The firm says its new Integrated Smart Trial & Engagement Platform (iSTEP) could in time replace conventional processes of managing clinical supplies.

For now the technology is still at the development stage. It’s passed a technical test and Janssen aims to run a pilot assessment of iSTEP within one of its own clinical trials by the end of this year.

The firm says it will then “progressively implement” iSTEP into a variety of clinical trials in its portfolio, and it is also keen for other pharma firms to use it too.

Andreas Koester, VP of R&D operations innovation at Janssen, said: "As clinical trials grow in complexity, duration and cost, we are adopting different technologies to optimise 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."

iSTEP has four components, covering tracking, communication, labelling and adherence, that can be used on their own or in combination.

Medication activities are registered and tracked via a scanner, rather than in paper files, at the study site and that information is made available to doctors and study sponsors via an online data portal.

Smartphoneapps then provide patients with information on areas such as dosing to encourage medication adherence and allow then to interact with their healthcare provider during the trial.

The programme offers smart packaging, in the form of electronic drug labels, that aim to augment existing booklets but can also be supplemented with other patient-specific data.

The fourth and final element of the platform sees it use smart medication blister packs to register each pill as it is removed, allow medication adherence to be tracked in real-time.

Overall it aims to capture real-time adherence data, eliminate paperwork and improve clinical trial processes for all those involved.

Leonard Chuck, medical director at California firm Diablo Clinical Research, said: "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.”

iSTEP was built as part of a collaboration with Tata Consultancy Services, which will deal directly with any other companies wanting to access the platform.

17th October 2017

From: Research

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