Map a Clear Business Benefit Outcome as Part of Your Technology Development Strategy for Using Wearables to Augment Clinical Trials
Although smartphones have proven effective for supporting the recruiting phase of clinical trials, the next step of using wearables with multiple health and activity sensors is very much in its early days.
“Seismic shifts in this market will not happen until the pharmaceutical lobby has confidence in the underlying systems supporting wearables, and that means that clinical validation expertise for wearables must improve,” said Mr. Shanler. “Right now, the big IT consultant firms barely understand the clinical domain, let alone the clinical wearable domain, which will be even more specialized. Tech startup and niche technology players will play a role with unique, and sometimes disruptive advances, but they are too small to provide the necessary confidence to the larger pharma.”
Since incorporating wearables into clinical trials will also require new processes and tools, new e-clinical partner models and technology partnerships will evolve. Most companies still do not know what to do with, or how to handle, wearable-generated data, so it will be up to healthcare and life science CIOs and IT leaders to suggest workflow and dashboards.
Ensure Wearables Meet Requirements for Regulatory Compliance and Information Security, and Can Operate in Clinical Conditions
In the long term, wearables will require better hardware, better sensors, and tighter integration into a mobile health (m-health) ecosystem that provides industry standards for maintaining health data integrity and security.
Current trends in miniaturization and growth of the Internet of Things (IoT) pretty much ensure that the eventual evolution of a viable m-health ecosystem is a question of "when" rather than "if." In the meantime many questions need to be addressed around data, calibration, compliance and performance.