A clinical trial is only done when there is good reason to believe that a new test or treatment may improve the care of patients. Tens of thousands of clinical trials register with the FDA each year to evaluate new therapies, but many of them fail to identify and recruit enough patients in a timely manner to clinically validate the efficacy of the treatment under study.
New digital technologies offer a different approach to capturing, analyzing and predicting patient behavior. An estimated 325 million people use connected wearable devices and more than 2.5 billion own smartphones.
Apple and Johnson & Johnson (JNJ) recently announced the launch of their new digital health study exploring the impact of Apple’s devices and a study-specific engagement program on cardiovascular outcomes among the Medicare population.
Apple in September 2019 announced its plans for a research app that would allow U.S. consumers to participate in health studies from their Apple devices. The app has gone live for both iPhone and Apple Watch for customers in the U.S. After enrolling in a study, participants using Apple Watch and iPhone can contribute useful data around movement, heart rate and noise levels — captured during everyday activities, from taking a walk to attending a concert.
First announced in early 2019, the Heartline Study is now enrolling seniors aged 65 years or older who are on traditional Medicare, and also own an iPhone 6s or later smartphone. These participants, the companies say, can sign up for the study remotely by downloading the Heartline Study app and releasing access to their personal Medicare data.
The Heartline Study will consist of two years of “active engagement,” and an additional year of follow-on data collection. Through this period, the companies said they will be looking for any changes in stroke risk and atrial fibrillation detection among the study population.
Takeaway: Pharmaceutical companies are increasingly investigating how digital devices can be utilized in clinical trials.