Janssen has launched what it claims is the first-ever completely decentralised mobile indication-seeking clinical study as the Johnson & Johnson company embarks on “the next evolution of digital clinical trial design”.
To accelerate the study and fast-track results, all contact with participants will be done virtually, with no in-person clinical visits required.
Drawing on previous experience, Janssen is utilising smart technology and wearable devices to more quickly and efficiently gather and analyse real-world evidence to assess the effectiveness of canagliflozin in adults with heart failure (HF), with or without type 2 diabetes (T2D).
Through a collaboration with global research organisation PRA Health Sciences and their innovative mobile clinical trial platform, CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure), will examine the use of canagliflozin compared to placebo on quality of life improvement scales, in participants with either preserved or reduced ejection fraction heart failure.
“Traditional clinical trials are undeniably essential in medical research but are often long and costly. Through the CHIEF-HF study, we are exploring how we can harness technology that consumers already have at their fingertips, including smartphones and wearable devices, to change this paradigm,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.
“Through this virtual trial approach, we hope to make clinical studies more inclusive, faster and more cost-effective, so that we can deliver innovative solutions to the people who need them.”