Assessing The Value Of Wearables In Interventional Clinical Trials

Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds through wearables in clinical trials.

In traditional pharmaceutical interventional clinical trials, collection of data for primary and secondary endpoints (objective and/or subjective) must take place in a clinical setting to maximize quality control and meet FDA requirements. In some cases, the FDA allows secondary endpoint data to be collected remotely (usually in the home setting), often through questionnaires completed by patients and/or their caregivers. Such data are usually subjective and as such are typically not sufficient for primary endpoint analysis in interventional trials. Novel wearable biosensors change the calculus by creating the opportunity to collect objective data outside the clinic.

Fuld & Company’s Life Science Consulting practice spans pharmaceuticals, biotechnology, diagnostics, medical device, health IT, and healthcare payers and providers.