RALEIGH – PRA Health Sciences is working to help clinical trials go virtual.
That’s because it has designed a new mobile clinical trial platform, CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure).
The global contract research organization with headquarters in Raleigh confirmed this week that Janssen Pharmaceutical Companies of Johnson & Johnson is using the platform to launch a clinical trial assessing the effectiveness of of INVOKANA® (canagliflozin) in adults with heart failure (HF), with or without type 2 diabetes (T2D).
PRA Health said it is the “first-ever completely virtual” clinical trial for drug indication.
“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 Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, in a statement.
To accelerate the study and fast-track results, all contact with participants will be done virtually, with no in-person clinical visits required. Janssen is utilizing smart technology and wearable devices to more quickly gather and analyze real-world evidence to assess the effectiveness of canagliflozin in adults with heart failure (HF), with or without type 2 diabetes (T2D).
The total study duration will be nine months and will be conducted in two phases.
“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,” said Stoffels.
Founded in 1976, the company moved its global headquarters to Raleigh in 2008. It specializes in clinical research, Phase I-lla, Phase II-lll, post approval, therapeutic exercise, biosimilars, rare disease and oncology.
Since 2000, PRA has participated in more than 3,800 clinical trials and participated in regulatory approval of more than 85 products. It now has over 16,000 employees operating in more than 90 countries.