Thaddeus Wolfram

	The application of personal device technology in the health care space continues to evolve, fed by the development of health-related consumer products and services by segments of industry traditionally not focused on health. The ubiquitous presence of smart phones provided the platform for the early and improving development of personal health-related apps, which were bolstered further by the entry and connectivity of activity-related trackers. While the consumer wearable space gained traction first for personal bio-stat tracking, the adoption of wearables as a clinical trial tool is taking hold. Early approaches have tested wearables as a method of driving healthier activity levels in patients whose sedentary behavior contributes to health problems.

	The next wave of wearable adoption in clinical trials will begin to use the devices as a source of outcomes data. Numerous collaborations have recently been announced teaming biopharma and technology/data companies looking to capitalize on wearable technology. In the simplest terms, these collaborations are based on developing the ability to remotely and/or continuously monitor clinical trial participants and collect participant data outside the walls of the clinic. Embracing this opportunity means managing both the apprehension and the hype that comes with adoption of a disruptive technological trend. The adoption of wearables in clinical trials will be reflective of how quickly clinical teams become comfortable with the various drivers of their apprehension. Currently, these drivers seem centered on identifying the right initial opportunities for wearables, the regulatory complexity involved in standardizing and controlling the data for collection in clinical trials, and the operational and design challenges they pose to trials, for example those relating to participant privacy.

	Future opportunities for wearables in clinical trials are likely to mirror penetration of wearables and mHealth in the consumer market, as this is indicative of what technology is already available, applicable and effectively utilized by people. Using this as a starting point offers an incremental step that has already been established and does not have to be developed from scratch with regard to ease-of-use and participant operability, effective data capture, data handling and encryption. Because of this, target trials will be those that either look to address high incidence chronic conditions also targeted by mHealth, such as diabetes or cardiovascular disease, or therapies where the biomarkers to be monitored can already be monitored by consumer wearables or existing patient-user diagnostic devices.

	Regulatory clarity on the use of wearables in clinical trials may take many years to evolve, meaning that navigating a certain level of ambiguity will be necessary for the foreseeable future. Drawing on experiences from the regulatory handling of companion diagnostics in clinical trials should prove a good starting point for benchmarking regulators’ expectations. Building upon this, the most important steps to take next are to plan ahead and communicate early and often with regulators. This provides an excellent opportunity to inform their understanding and interpretation of your use of wearables in a clinical trial, and elevate your ongoing discussion with them to better refine your plans and reduce the risks of incorporating wearables.

	Tackling the operational and design challenges that wearables pose to clinical trials requires breaking through the hype and not getting stuck in today’s consumer ideas of mHealth and wearables, but rather refocusing on the reality of what wearables can provide clinical research. That reality should be directly tied to using wearables to improve safety and efficacy outcomes data and streamlining clinical trials, with leading practices in the near-term focused on mitigating the following unique challenges created in collecting clinical data outside of a controlled research environment. With these goals in mind, the key challenges include:

. The flip side to the advantage of capturing real-life patient data is the data could be impacted by individual participant variability related to the environment the participant is in and his or her physical state at the moment of data capture, which is potentially amplified by ranging variabilities between participants. Researchers, therefore, need to consider the context within which all data is captured, as well as how they will parse through the volume of information that can be made available to them through wearable participant monitoring, and provided by an expanded participant base made available through advances in mHealth technology.

. Wearable monitoring requires a different level of participant commitment. A participant could remove the wearable for a period of time, not adequately charge the wearable or knowingly or unknowingly damage the wearable - all potentially impacting data capture in some way. Planning ahead to mitigate for and react to these scenarios is an important step when designing for use of a wearable in clinical research. That said, wearables are also expected to help with enrollment and retention in clinical trials by making participation more patient-centric and improving accessibility through digital channels and remote engagement.

. In addition to meeting regulatory requirements for electronic records and signatures, and validating compliance across computer systems collecting and analyzing clinical data, researchers need to take care in planning for how they will determine and show the validity of data not directly observed. For example, if a participant transferred his or her wearable to another individual, how would that be caught, how would it be managed, how could it be guarded against and, therefore, if necessary, be shown that it did not happen?

. Maintaining a secure environment around wearable collected data can start with comparing the proposed practice for securing the health data with generally accepted security and privacy controls and standards. Practices from mHealth developers can then be leveraged for tackling additional wearable security issues, such as the ability to remotely wipe the data from a lost device.

	Focusing on these challenges will help to establish leading practices in the near-term that both control for some of the chaos that might otherwise derail successful inclusion of wearables into a clinical trial, and also ground early advances in the reality of what is achievable.

	Recognizing and addressing these drivers will help in getting past the apprehension that will plague some groups as they hesitate to bring wearables into their clinical development world. The first movers will likely encounter some unforeseen bumps in the road, but as they gain experience using wearables, they may find distinct advantages across three facets of clinical development:

	1.     Generating better data more quickly, leading to faster approvals, faster fails and better insights for maximizing reimbursement

	2.     Creating a more thorough safety profile, reducing risk and allowing for more specific labeling

	3.     Understanding how to innovate and incorporate new technologies and diagnostic monitoring capabilities into wearables, providing competitive advantage more broadly across the future R&D portfolio

	With the ever-increasing expectations from patients and physicians, payers and regulators, and not-to- be-forgotten shareholders, the need to continue to improve on the value that is returned from biopharma R&D efforts dictates that opportunities like those presented by wearables not be taken lightly. As major technology players dive in with tools, such as open source frameworks and connectivity platforms to better enable clinical research through wearables and personal devices, the industry is taking the next step toward realizing the value that wearables can have on clinical development. While there are specific near-term challenges that deserve early focus to drive clinical trial success through wearables, it is also important to consider the strategic and organizational implications of the trend. Wearables offer an opportunity to flip clinical trial design and protocols on their head, leading to a complete rethinking of what clinical trials look like. And depending on a company’s approach to wearables, there is further opportunity to shake up organizational structures and roles, in a good way, as the clinical development, regulatory, medical affairs and pharmacovigilance functions of an organization are adapted to optimize the value that wearables can bring.

The views expressed herein are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.

Thaddeus Wolfram is a senior manager in EY’s Life Science Advisory practice.  He can be reached at 

Articles

The application of personal device technology in the health care space continues to evolve, fed by the development of health-related consumer products and services by segments of industry traditionally not focused on health

Thaddeus Wolfram

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Wearables: Where is Clinical Development Headed Next?