The Janssen Pharmaceutical Companies of Johnson & Johnson is reimagining digital clinical trial design with the launch of a new study.
Known as Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF), the trial is a completely decentralised, mobile, indication-seeking clinical study. It will involve a population of patients with heart failure, with or without type 2 diabetes.
It is expected to use personal smartphones and wearable devices to track participants, with no in-person clinical visits required. It will also include an individualised patient-centric outlook.
The trial aims to enrol around 1,900 adults in the US and will examine the safety and efficacy of INVOKANA (canagliflozin) compared to placebo in participants with both preserved ejection and reduced ejection fraction heart failure.
Johnson & Johnson Executive Committee vice-chairman and chief scientific officer Paul Stoffels said: “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.
“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.”
The study will enable Janssen to use technology to make traditional healthcare models more patient-centric and cost-effective.
Janssen hopes the observations seen in the CHIEF-HF study will support the clinical data results in Invokana’s other Phase III clinical programmes.