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R&D Operations Innovation Is Exploring Initiatives to Improve Patient-Centered Clinical Trials

Janssen Research & Development Operations Innovation is dedicated to developing new strategies and solutions to improve the clinical trial experience for patients. Some ongoing initiatives include:

iSTEP (integrated Smart Trial & Engagement Platform)

This is an integrated technology platform currently under development that aims to transform clinical trial medication and data management in general and enable end-to-end patient engagement. The initial scope of the iSTEP platform, referred to as “eMeds,” focuses on medication management and adherence.

Electronic Informed Consent

The tablet-based electronic informed consent (eConsent) process provides an interactive educational experience for the prospective clinical trial participants.  It includes multi-media features to help patients understand clinical trial requirements, risks and patient rights. Janssen pioneered implementation of eConsent in multi-country/multi-language trials and is providing leadership in the TransCelerate BioPharma eConsent initiative.

Patient Voice in Trial Design

This initiative explores a variety of approaches to seek and incorporate direct patient perspectives into protocol development and planning to proactively address potential enrollment and retention challenges during early stages of clinical trial development.

Patient Access to Trial Data

This initiative aims to improve patient engagement by giving patients on-demand access to their routine lab data collected in the clinical trial. A secure patient portal offers patients the opportunity to view, download and share their data with others, such as their primary care provider. We hope to build on our learnings to establish a direct link in the future with patients for continuous engagement before, during and after the trial.

Clinical Trials

Clinical Trials

Donna Williams, Discovery
Donna Williams, Discovery