Johnson & Johnson’s pharmaceutical arm Janssen is launching its first completely virtual clinical trial, using personal smartphones and wearable devices to track participants with no in-person site visits required.
The decentralized study, dubbed CHIEF-HF, aims to gather real-world evidence to support a new cardiovascular indication for its diabetes drug Invokana (canagliflozin). The trial aims to enroll about 1,900 adults in the U.S. previously diagnosed with preserved or reduced ejection fraction heart failure, including those with or without Type 2 diabetes.
Through a collaboration with PRA Health Sciences, participants will use a mobile clinical trial platform to gauge changes in quality of life, compared to placebo, using app-based questionnaires. Meanwhile, physical activity data will be logged by the smartphone and a wearable device, including daily step counts and stairs climbed.
“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,” J&J Chief Scientific Officer Paul Stoffels said in a statement.
“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,” Stoffels said. Janssen hopes the findings of CHIEF-HF will support the clinical data seen in Invokana’s other phase 3 studies.
Participants for the virtual trial will be recruited through large health systems and integrated delivery networks as well as via email and smartphone apps. Their personal mobile devices will also be used to screen, gather consent from and onboard them into the nine-month study.
Patients will first be randomized to either Invokana or placebo for three months of treatment before entering an open-label data collection period—with the goal of determining the impact of knowledge from a randomized clinical trial on its participants and their subsequent behaviors.
“Additionally, CHIEF-HF is focused on the patient experience, returning their own data to them in a staged manner that allows them to understand how treatment and lifestyle choices affect their health,” said Paul Burton, Janssen’s vice president of medical affairs for internal medicine.