Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC
What is mHealth Technology and what are Wearable Devices?
Clinical research is a discipline that is constantly evolving. Currently, the most rapid innovation is occurring in the use of mobile health technology (or mHealth). In particular, wearable devices (also called wearable gadgets or simply wearables) for data-gathering are becoming a major focus for many pharmaceutical companies.
The integration of wearables with smartphones has made the collection of a continuous stream of real-time data less disruptive for participants. This emerging digital research platform holds the potential for increasing the accuracy and timeliness of data, improving clinical efficiencies, and promoting greater patient engagement in the clinical trial process.
Two mHealth Paradigms
While there is certainly a place for wearables in clinical trials, there are differences in opinion regarding how they should be integrated with the trials. These differences fall into two paradigms:
Some researchers want to leverage new mHealth technology within the traditional clinical trial model. They believe that the use of mHealth technology is not an all-or-nothing proposition, and that devices should be utilized where clinically appropriate depending on the indication, phase, level of risk, and many other considerations, within the traditional clinical trial model. In this paradigm, the adoption of mHealth would be analogous to the adoption of email. While email has many advantages over physical mail, it has not eliminated the use of it.
Many large pharmaceutical companies increasingly advocate for an overhaul to the traditional clinical trial model. They envision a future where clinical trials are performed as virtual, site-less studies, with subjects participating from anywhere in the country or world, and data being collected and organized by a centralized coordinating center. Using this approach, subjects could participate in a study from the comfort of their home.
Currently, advocates of this paradigm appear to focus less on the validation of wearables with regard to feasibility in the subject population and integrity of data, and more on strategies for adoption. Moreover, adoption is planned on an indication-wide level, rather than reaching for a global solution that could address the variability in projects of different phases or with different risks.
While Paradigm 2 may be the ultimate goal of the next revolution in clinical trial data-gathering, the first paradigm is the stepping stone to achieve this goal.
The Current Conversation Around mHealth Adoption
Today, the discussion in our industry is still primarily focused on the adoption of wearables rather than best practices. At present, few companies have wholeheartedly embraced the use of wearables and are wary about relying too heavily on the devices. At PROMETRIKA, we see this period as the perfect time to be gathering information from various mHealth technology providers and developing best practices for use of the technology.
For those lobbying for the adoption of wearables, there are many good arguments. First, regulatory agencies like the U.S. Food and Drug Administration, have indicated acceptance of wearable technologies. Second, wearables are already in use for diagnostic purposes (e.g., insulin pumps, 24-hour Holter monitors), so it seems reasonable to move them into the clinical trial space. Finally, as more organizations are having success with wearables, others point to these innovators as trailblazers who have created a path that can be followed with minimal risk and potentially great rewards.
When companies decide to adopt mHealth technologies, there are strategies they can use to help ensure success. The first is to document an adoption plan. This involves meeting with key stakeholders, establishing tangible goals, and creating processes and a timeline for meeting the objectives. Another is to form a dedicated innovation team. This group is charged with researching all the available options and validating them internally. Whatever steps are taken to transition to the use of wearables, it is important to understand that a significant commitment of time and capital will be invested.
Eager to make progress, pharmaceutical companies are already adapting existing technology and business models for clinical trials. They are testing the limits of both consumer- and medical-grade devices, as well as the inherent capabilities of smartphones. In one novel use, an orthopedic trial leveraged the gyroscope technology in an iPhone to provide data to measure improvements in range of motion.
Validating Wearable Devices
One of the keys to gaining acceptance for wearables is conducting validation studies to determine a device’s general suitability for use in trials and its appropriateness for a specific clinical indication. A device might be effective at capturing data but not practical for the population involved in a study. For example, participants with tactile issues might find a wrist strap intolerable. In one study, a child with developmental delay swallowed a wearable, proving that there can be consequences when a device is not properly validated for a particular population.
Generally, there are two grades of wearables being used for clinical trials: consumer and medical. Consumer-grade devices include products like the FitBit wristband and the Misfit Wearables clothing tag, which can provide information such as activity level, heart rate, weight, and body mass index (BMI). Medical-grade devices like Philips’ wearable biosensors, which are often used in low-acuity hospital settings, capture similar information plus other data like skin temperature, single-lead electrocardiogram (ECG), and posture. The suitability of a device for a particular study involves a number of factors including cost, sensitivity, calibration capability, and the level of familiarity that subjects have with the technology.
Another measure of a device’s ability to meet the needs of a particular trial involves the vendor’s data transfer specification. Can the data be separated out into epochs of a specified length? Can variables such as the serial number of the device, which you might use to confirm that the data came from the right participant, be included in the data set? What is the dataset file format? These are important questions to ask. And, of course, with any wireless transmission of data, there are understandable concerns about the privacy of patient information.
Data Volume and Analysis Considerations
The quantity of data delivered by wearables is another critical consideration. Traditional data analysis methods may not be sufficient to handle data from wearables, for a number of reasons. A prime consideration is the massive amount of data that wearables are capable of sending. Another important issue is data “noise.” Some of the data you receive may not be clinically relevant. Most importantly, novel signal detection algorithms and methodologies are needed to filter out the information you don’t need.
While some data and wearables vendors employ teams of data scientists dedicated to advancing data analytics for clinical trials, their data processing algorithms may not be released for biostatistical validation. What’s more, the raw data is often not accessible and the output that is provided is done so only in an aggregated report, which only allows for the qualitative identification of trends. So, challenges to full adoption of wearable devices in clinical trials remain.
Are We Ready to Rely on Wearables?
In summary, it’s clear that the use of wearables offers many benefits. Not only can they speed up trials, they can also make data more objective. However, data experts will need to come up with best practices for sifting through the huge amount of data that will be produced. And, sponsors, CROs, and medical scientists involved in trials must realize that there may be key endpoints for which our industry is not ready to rely on wearables. In the end, companies willing to invest resources in the adoption of mHealth technology will be on the forefront of the industry and surely will reap significant rewards.