Wearables pave way for reimagined clinical trials

Written by Ilana Landau, Editor
Cardiopulmonary and vascular Diabetes Health technology assessment Medical devices, pharmaceuticals and vaccines News Real-world evidence Stakeholder engagement

Janssen (Beerse, Belgium) has launched the first ever, fully decentralized clinical trial, investigating the effectiveness of INVOKANA® (canagliflozin) in individuals with heart failure. The novel trial design seeks to improve the speed and cost-effectiveness of medicine provision to patients.

Janssen (NJ, USA) has announced the launch of the first ever, fully decentralized clinical trial, investigating the effectiveness of INVOKANA® (canagliflozin) in individuals with heart failure, with and without Type 2 diabetes. The innovative trial design will employ smart technology and wearables to improve the speed and cost—effectiveness of medicine provision to patients by allowing all contact with study participants to be done virtually.

The trial, entitled Canagliflozin: impact on Health status, qualIty of lifE and Functional status in Heart Failure (CHIEF-HF), will examine the effects of Invokana on the quality of life improvement scales of participants with preserved or reduced ejection fraction heart failure.

To fast-track results and reform the traditional clinical trial design to be more patient-centric and cost effective, all contact with study participants in CHIEF-HF will be done virtually, leveraging participant-reported outcomes from app-based questionnaires and physical activity data logged on smartphone apps. This will ensure no in-person, clinical visits are required. Janssen hopes this will allow for the more rapid and efficient collation and analysis of real-world evidence.

Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson (NJ, USA), commented: “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.”

Source:

https://janssen.com/janssen-leverages-wearable-technology-reimagine-clinical-trial-design