Building off the success of the Health eHeart study, the University of California – San Francisco (UCSF) has received nearly $10 million from the National Institutes of Health (NIH) to launch the Health ePeople study platform.
The Health eHeart study was launched 2013 as a model of the prospective cohort study of the future, something of a Framingham study for the 21st century. The study is enrolling patients worldwide with the only criteria, aside from age, being ownership of a smartphone. Through the app and paired devices, participants are contributing biometric data like blood pressure with the iHealth connected blood pressure device, single-lead EKG tracings using the AliveCor device, and passively collected activity data using the Ginger.io platform. In addition, they are are entering health data like their past medical history and a detailed family history.
Health ePeople is being framed more as a research platform that will facilitate research, both observational and interventional, on an unprecedented scale. According to Dr. Jeffrey Olgin, UCSF Chief of Cardiology,
“The primary goal of Health ePeople is to provide a resource enabling convenient and efficient mobile and wireless health research. It will help investigators collect mobile health data via integration with sensors, devices and apps, deliver online surveys, connect with external data sources including electronic health records, and use novel methods for ascertaining and adjudicating clinical outcome events.”
The Health ePeople study is occurring the the context of a broader push by the NIH and other funding agencies to fund more pragmatic clinical studies at lower costs. Prospective cohort studies that follow healthy people for many years have provided invaluable insights into a wide range of insights. These studies however involve a lot of labor intensive (read: expensive) work like in person visits, follow up phone calls from study staff, and more. Clinical trials face similar challenges. With NIH funding falling, there has been a lot of focus on how this type of work can be done with for less money.
Nearly four years ago, Pfizer piloted a “virtual” clinical trial of a drug for overactive bladder, comparing it to the already completed traditional clinical trial. Since then, we’ve seen a growing trend of pharmaceutical companies increasingly engage with digital health for research purposes.
As Health ePeople gets underway, it will be interesting to see how lessons from Health eHeart as well as other digital cohort studies, such as the numerous ResearchKit studies underway, inform the design of actual clinical studies. Researchers will have to consider and address challenges like the quality of user-entered health history, accuracy of activity data, and plethora of digital health devices that can measure the same thing (e.g. blood pressure) with varying degrees of accuracy. In many ways, it seems like Health ePeople is an investment in designing and defining the future of clinical research.