The Future of Drug Trials Is Better Data and Continuous Monitoring

Digital technologies are becoming ubiquitous, effective, and cost efficient, but are underutilized in medicine. These technologies — like wearable health monitors, sensors, and even ingestible devices that can measure everything from how many steps you take, to blood pressure, and how a drug interacts with your body once ingested — have the potential to disrupt every aspect of health care, including high-stakes, high-cost drug development. Specifically, these devices can revolutionize the antiquated process of developing new drug therapies and can vastly improve how we collect, measure, and assess health data so that we can offer new treatments to patients without wasting valuable time and limited resources.

Clinical trials are designed to evaluate whether a new drug is safe and effective while protecting volunteer patients participating in the trials from risk. All good intentions, but some of today’s research processes date back to 1946. New and proven digital technologies can make drug development smarter, better, and faster.

These technologies, many of which are built on machine learning and artificial intelligence (AI), are already being used to help patients and health care providers remotely manage chronic conditions such as hypertension and diabetes. Consumer are also turning to these devices to help them lose weight, increase their daily activity, and sleep better. It’s time to apply them to drug development in order to more efficiently, frequently, and accurately gather and analyze data from trial participants and present actionable information to researchers and health care providers. With advanced data analytics capabilities, digital technologies can even interpret results better than humans, who are often biased or limited by their experiences, preferences, capacity to absorb information, and knowledge base.

We call the application of digital technologies to continuously and unobtrusively measure an individual’s physiological data continuomics. By tracking things such as heart rate, blood pressure, and other biomarkers that indicate your state of health, they can transform current clinical research in a number of ways and make possible virtual clinical trials.

What Continuomics Makes Possible

Digital technologies will allow researchers to measure the health data of clinical trial participants on a regular basis during the normal course of daily living without significantly disrupting them. They will make it possible to more accurately assess an individual’s health as well as how the study drug is performing. They also will significantly reduce the number of visits to a doctor required of participants, which is particularly difficult for individuals who are working and is a common reason patients drop out of studies.

Regularly or continuously measuring an individual’s response to a potential drug therapy in real time will give clinicians a better understanding of how that drug impacts the disease and its interaction with an individual’s overall health. Historically, study participants have been tested or evaluated at specific “point-in-time” assessments. However, these scheduled tests provide clinicians with only a fragmented understanding of how the study drug impacts the disease and interacts with an individual’s overall health. Once-a-week measurements in a 12-week trial, for example, are not often enough to get an accurate assessment of how a drug is impacting a disease or an individual’s reaction to the study compound.

Given that the true goal of a clinical study is to obtain the most accurate, meaningful, and useful data, the frequency of measurements should be determined by our best understanding of the underlying biology, not by precedent (“we’ve always done it this way”) or a predetermined schedule. To put it in technical terms, the measurements need to be commensurate with the change in the variable being measured. Known as Nyquist frequency, this identifies how often measurements should be conducted and accounts for the natural variabilities in an individual’s health or their underlying disease, including changes in blood glucose, pain levels, blood pressure, or heart rate.

Measuring “often enough” requires study participants to be tested and evaluated as unobtrusively as possible, creating little disruption in their daily lives and reducing the anxiety commonly associated with doctor’s appointments (“white-coat syndrome”) that can result, for example, in arbitrary high-blood-pressure readings. Digital technologies enable us to change how often we can collect and assess important clinical measures and improve the accuracy of these measures and the quality of the resulting conclusions.

Digital technologies can allow researchers to detect adverse events to a drug therapy earlier. These events include medication errors, drug reactions, allergic reactions, and overdoses. The devices also can enable researchers to glean better insights into these events when they do occur.

The devices will make it possible to measure important quality of life indicators, including daily activity and sleep quality. This capability has broad implications in health care, such as supporting more informed decision making, improved patient engagement, and a more personalized approach to care delivery. This data will also help to create a better understanding of the relationship between cost and value of drug compounds.

In virtual clinical trials, researchers will be able to easily track adherence to the study protocol — that is, whether the patient is actually taking the therapy, as prescribed. This is important because nonadherence can create false or misleading data and affect the safety and efficacy of an investigational drug. Text messaging and smartphone apps have proven to be effective means of reminding patients to take their medication, provide education and information about their condition, and even conveniently schedule an appointment with their doctor.

Where Do We Go from Here?

Continuomics will make possible radically new designs for clinical trials — with more targeted interventions, shorter duration, and fewer participants — thus lowering costs, increasing efficiencies, and potentially bringing important new therapies to market faster.

But clinical trials are just the beginning. Continuomics will be an important contributor to realizing the vision of personalized medicine, allowing health care providers to precisely predict an individual’s risk of getting certain diseases as well as his or her response to specific therapies based on his or her genotype (genetic information) and phenotype (human traits and behaviors). By linking information about an individual’s genotype and the phenotype, continuomics can lead to individualized diagnoses and therapies on a scale previously unimaginable.

Changing health care can be a slow and laborious process. However, we are starting to see opportunities materialize that will help open doors for digital technologies, including new reimbursement codes approved by the Centers for Medicare & Medicaid Services for activities such as remote monitoring.

In addition, a number of major pharmaceutical companies have already begun exploring applications for digital technologies in their early-stage drug trials. Even the U.S. Food and Drug Administration (FDA) has stated that digital technologies represent “important opportunities to modernize clinical trials.”

We believe the challenge to implementing continuomics is not primarily technical; rather, it’s the medical community’s aversion to adopting new protocols and technologies. Innovation is needed not just in the development of new drug therapies and advancement of treatments but also in the way we measure health.