The promise of wearable devices only goes so far

Much has been written about the growth of the US wearable market. By 2019, over 33% of the population is projected to own a wearable device with the largest growth being seen in the 65+ segment. Many believe that these devices have the potential to drive clinical trial recruitment: so far, a handful of studies have largely validated the safety, security, and regulatory compliance of these devices along with their ability to dramatically shorten recruitment timelines.

The Medidata MOVE-2014 type II diabetes study provided participants with three pieces of mobile technology: an easy to use activity tracker; Medidata's Patient Cloud ePRO platform; and smartphones capable of receiving text notifications. The trial showed that participants were highly compliant with wearable use and collected data were securely transferred and integrated into the cloud. Similarly, a recent Stanford heart disease study that utilized Apple’s ResearchKit allowed researchers to recruit 11,000+ participants in roughly 24 hours, a monumental task that historically would have taken 50 medical centers a year to complete.

At the same time interest in wearable use in the clinical trial space has increased, there has also been a renewed focus on diversifying clinical trial participation. And why not? It’s been nearly 24 years since the NIH Revitalization Act was signed into law with the express aim of increasing clinical trial participation among women and minorities. The same year the Revitalization Act was passed, the FDA removed restrictions that had previously prevented women of childbearing potential from participating in a wide variety of clinical trials, thereby increasing the number of female trial participants.

Has the push for more inclusive and representative recruitment worked? Not for the minority segment. In 2016, Black Americans comprised 13.2% of the population but 5% of clinical trial participants. Similarly, Latinos made up 16% of the population but 1% of study participants. Whites accounted for 67% of the population and 83% of research participants. And women? 51% of the population but 55% of clinical trial participants. Compounding matters, recent research has shown that income is the only socioeconomic factor associated with clinical trial participation in a statistically significant way. Those earning less than $50,000 a year are 27% less likely to participate and those earning $20,000 or less per year have the lowest rates of clinical trial participation.

Clearly, wearables—and fitness trackers in particular—have the ability to drive study enrollment, but are they able to help diversify trial participation? Unfortunately, the numbers aren’t promising: 36% of fitness tracker owners are 35-54 years old; 41% earn an average income of over $100,000 a year; and 54% are female.

As wearable and fitness tracker prices drop and these devices flood the market, consumers may well become more demographically diverse. In the meantime, if sponsors and CROs want to harness the power of wearables to drive study enrollment, they should seriously consider providing these devices free of charge to study participants.

Cross-posted at http://richiekahn.wordpress.com and https://epatientfinder.com/promise-wearable-devices-goes-far/

Health policy wonk by training and clinical researcher by trade, Richie is Director of Life Science Business Development at ePatientFinder, a cutting edge patient recruitment company that leverages the trusted doctor/patient relationship and the power of EMR data to drive recruitment.