The number of small, pilot clinical trials to evaluate new wearable devices continues to grow, as the once-untested technology is becoming another research tool for companies focused on developing new sensors for both handheld and wearable products.
Just last week, Propeller Health, a provider of an FDA-cleared digital health system for people with chronic respiratory diseases, announced a development agreement and R&D collaboration with GlaxoSmithKline for its Ellipta inhaler, the drug company’s patented dry powder inhaler. The inhaler will join the ranks of devices used in trials, a number that recently topped 300, according to Bloomberg.
Propeller will develop and manufacture a custom sensor for the Ellipta inhaler that will be used in GSK clinical studies in asthma and chronic obstructive pulmonary disease (COPD). In those studies, Propeller’s new sensor will automatically collect and record data on the inhaler’s usage and wirelessly transmit the information to a central data repository for researchers to analyze. The company also has developed a comparable system for Boehringer Ingelheim’s Respimat inhaler that received FDA clearance earlier this year.
“Using innovative sensor technology to improve the quality of adherence data collected during our studies will advance our understanding of disease and inform our decision-making in the development of new medicines,” David Allen, senior vice president of respiratory research and development at GSK, said as the deal was announced.
This year also marked the introduction of Apple’s ResearchKit, a new open source software framework designed for medical and health research apps that makes it easier for researchers to recruit volunteer participants for large-scale studies. Researchers are able to ask iPhone users from around the globe to download their iPhone apps and thus participate in medical studies.
The past 12 months also showed a variety of wearable devices from wristbands to Band-Aid-size patches that can provide patients and physicians with a variety of health-related data points beyond the basic Fitbits used by consumers. Among them:
Given how growing numbers of wearables seem to be a logical fit in the world of clinical trials, there also are a number of hurdles ahead including a challenging infrastructure as well as validation, security, privacy and protocol development issues, Michael Shanler, research director at Gartner Group, wrote in a recent blog posting.
Although the use of mobile devices will expand, wearable devices will be leveraged in fewer than 10% of clinical trials, according to Gartner. Success will depend on the ability to integrate wearables with data exchange and cloud-based analytics, along with the connection to eClinical systems.
“Seismic shifts in this market will not happen until the pharmaceutical lobby has confidence in the underlying system supporting wearables, and that means that clinical validation expertise for wearables must improve,” said 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.”
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 19, Issue 48, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »