Janssen has announced the launch of a new “evolution” in digital clinical trial design; CHIEF-HF, the first-ever completely decentralised, mobile, indication-seeking clinical study.
The trial will be completed virtually, with no in-person clinical visits required in order to "accelerate the study and fast-track results”, utilising smart technology and wearable devices to more quickly and efficiently gather and analyse real-world evidence.
The study will be evaluating Invokana (canagliflozin) in adults with heart failure, with or without type II diabetes, compared to placebo on quality of life improvement scales, in participants with either preserved or reduced ejection fraction heart failure.
Traditional clinical trials are still "undeniably essential in medical research but are often long and costly” explained Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.
He continued, “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. 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.”
As a part of the new system, investigators will analyse participant-reported outcomes through app-based clinical questionnaires, and physical activity data as logged by an app on the smartphone and actigraphy data from a wearable activity device, including daily step count and stairs climbed.
Around 920,000 people in the UK today have been diagnosed with heart failure, but both the incidence and prevalence of heart failure increase steeply with age, with the average age of diagnosis being 77.