Despite the recent boom and popularity of wearable technology, it isn’t a new thing. Wearables in clinical research have been around since the 1950s to track activity and since the ‘70s to track circadian rhythms. In recent years, more and more consumer devices have entered the arena of clinical research, with several big names, including Johnson & Johnson and Apple, working together in an attempt to collect patient data in real-life conditions. From rings and headbands to track sleep, to super-sophisticated all-in-one watches, their contribution to patient data monitoring can potentially be huge.
The Patient Comes First
It might sound like a cliché, but in the marriage of technology and clinical research, the patient should come first. In most clinical studies, the patient is required to travel to clinical sites in order for site staff, and by extension the study team, to collect the patient’s answers and results, often via a long list of arduous questions and examinations. Furthermore, this type of data is collected during agreed-upon visits, in a non-continuous way and can be affected by a plethora of factors, including, for example, the stress of hospital visits or seasonal fluctuations in hormones. Patients may also need to try to remember and accurately collect information manually between visits.
Wearable technology, which is becoming increasingly more user-friendly, has the potential to alleviate the patient burden and acquire data in real world, rather than just clinical settings. As such, the capability to receive timely and accurate data collected passively (not reliant on manual patient reporting) offers an endless potential to enhance clinical research and health monitoring.
Different Types of Sensors
The table below gives examples of sensors that can be used alone or in combination to measure physiological parameters relevant to disease states.
Best Practices and Considerations
As with all things new and exciting, the implementation of wearable technology in medical research comes with challenges. Players in the field must acknowledge the need for regulation and standardized endpoints in research.
In addition, generating data around a patient has brought ethical questions. Study teams need to carefully consider how they will monitor and access patient data without putting the patients’ sensitive information and privacy at risk. Hence, the inclusion of data security, privacy and research ethical experts in study design is paramount.
Device and data management implementation processes differ significantly based on the category of devices used. In the case of consumer-grade devices, device distribution, support, data flow, and data ownership are in the hands of vendors who often don’t have the capacity to support large scale global clinical trials. In medical-grade devices, which do share some of the consumer device gaps, albeit to a lesser extent, there is often a lack of design consideration, making the devices aesthetically less attractive to patients often at a significantly higher cost. It will be interesting to see how the FDA strategy on regulating wearable technology will evolve following FDA commissioner Scott Golieb’s recent departure. Golieb has been a strong advocate for health care innovation.
From my perspective, the most important and biggest positive outcome from the use of wearable technology in clinical research is the empowerment and the feeling of inclusion for the patients. The fact that the study design becomes more patient-centric can have a tremendous impact on patient recruitment and retention as patients are actively engaged in their health management. Ultimately, it is not just about saving patient lives by designing better medication, but also about giving them a chance of a better quality of life.