Human beings are creatures of habit. As this writer can attest, an almost daily routine of activity is quite predictable—should anyone actually care. For a journal author—not really, however, for patients—yes.
For those patients who are participating in the imperative clinical research project, this is even more important. With the advent of a digitally connected world, with all kinds of new wearables and devices that can seamlessly collect health-critical data points which in aggregates—over time—into digital gold.
Enter the authors of “The Future of Drug Trials is Better Data and Continuous Monitoring” who explain why it is time to change how we conduct clinical research. Among them is Joseph Kvedar, who as VP of Partners HealthCare knows something about the topic of medical research.
What has been called the “internet of things” (e.g. all devices connected in a pervasive digital network) has come to healthcare (and inside the human body) in what the Kvedar, et al refer to as “Continuomics” or “the application of digital technologies to continuously and unobtrusively measure an individual’s physiological data.” Today, the capability affords many different health data collection opportunities—now just applying in a systematic, secure and scalable ways to clinical trials.
The authors remind the reader that many clinical trial laws may go back more than 50 years. There has been considerable technological transformation and the rules, policies and procedures of today may need, in some cases, a reset. Why? Because, to tap into, access and benefit from continuomics, it would absolutely require a change across the board in rules, policies, in procedure and how we understand, map out and manage risk for compliance purposes.
Read the article for what continuomics makes possible in the context of clinical research. It’s already happening. Think about telehealth platforms and what that can do for transforming how patients living in rural areas with less access to academic health systems, for example, can possibly participate easier. There are now thousands of apps in the market to collect various information—hundreds of serious medical apps in use in serious and profound ways. In Q3 of 2018 alone, 34 new apps were approved by the FDA.
So, with a transition to continuomics, the digital network allows medical researchers to tap into regular (continuous) “measuring of an individual’s response to a potential drug therapy in real time.” A whole new world opens up with a goal of securing accurate, meaningful and useful data, ongoing and in real-time. We are on the cusp of a transformation not only in clinical research, but in healthcare itself.
Change is hard to do; humans are creatures of habit. In “Where do we Go from Here,” the authors at least mention the crux of the challenge—that it is not technical but rather medical community’s risk averse nature. Fundamental issues ranging from data privacy and protection to federal and state regulatory health and research requirements must evolve in a somewhat cohesive manner to effectuate change. As laws change, so do federal and state rules, and associated guidance. Thereafter, large organizations get on the bandwagon. Of course, the opposite approach is that the marketplace will pull the laws and rules toward the new demands of clinical researchers. This is already happening per the authors. In the United States, this will happen in a myriad of ways at the federal, state, regional and local levels.