Johnson & Johnson and Apple recently launched a unique first virtual randomized clinical trial and are already recruiting patients much faster than standard studies. The Heartline trial is designed to explore whether its heart-healthy app, combined with the irregular rhythm notification (IRN) and electrocardiogram (ECG) apps from Apple Watch, can help reduce the risk of stroke cerebral. The new virtual model means that people can participate remotely throughout the study without having to go to research sites. Heartline opened on February 25 and the study quickly recruited 4,000 patients in the first days after the study was launched.
The study represents the largest randomized trial in the history of cardiovascular disease and is testing the new virtual model to break down some of the most common barriers to participation in clinical studies, said Paul Burton, vice president of medical affairs at Janssen Pharmaceuticals, part of Johnson and Johnson.
Health studies that use digital applications should have much higher enrollment rates and lower overhead costs than traditional approaches. “Randomized clinical trials are ineffective, and the generation of data from them is too slow – these are the key areas for improvement that we wanted to address,” said Dr. John Whang, head of cardiovascular and of metabolism in Janssen. According to Dr. Whang, part of the reason for the inefficiencies is the slow enrollment rates. Less than 5% of eligible patients enroll in trials, which leads to around 80% of studies that do not finish on time and many are delayed by six months or more. Most sites have an average of a handful of patients per year, and up to 50% of sites register only one patient, if at all.
“From the patient’s perspective, being able to participate in a clinical trial without having to go to a physical site can be attractive,” said Dr. Whang. “Patients with autoimmune diseases like multiple sclerosis, arthritis, inflammatory bowel disease, cancer, heart failure, or eye diseases – to name a few areas of interest in biotechnology pipeline – may find it difficult to travel for in-person visits due to their underlying condition. “
The Heartline study is open to people 65 years of age or older, residing in the United States, having an iPhone 6 or later, and agreeing to provide access to their original Medicare claim data. This is a rigorously designed, nationally controlled virtual clinical trial sponsored by Janssen. Apple’s expertise in the design, technology and security of digital products has supported the development of the new Heartline app. The study aims to determine whether the Apple Watch app and features can improve outcomes, including the risk of stroke with early detection of atrial fibrillation (AFib). AFib is a common form of irregular heartbeat that affects approximately 6 million people in the United States and is one of the leading causes of stroke.
“Heartline is a study that has the potential to fundamentally change our understanding of how digital health tools, like the ECG app and the irregular rhythm notification feature on Apple Watch, could lead to earlier detection of ‘AFib, helping patients understand and engage directly in their hearts. ” health, sparking potentially vital conversations with their doctors and improving health outcomes, “said Dr. C. Michael Gibson, Heartline Executive Committee co-chair and professor of medicine, Harvard Medical School and CEO, Baim Institute, in a statement .