Wearable Devices Being Used in Drug Trials, Medical Research
Pharmaceutical companies are enlisting Fitbits and other gadgets strapped to patients’ wrists, chests and skin as a way to bring drugs to market faster.
What began as an aid for athletes and dieters to track their movements is quickly becoming a critical tool for medical researchers and drugmakers. By outfitting trial participants with wearables, companies are beginning to amass precise information and gather round-the-clock data in hopes of streamlining trials and better understanding whether a drug is working. Down the line, wearables also could help pharmaceutical makers prove to insurance companies that their treatments are effective, thus reducing health costs.
“The use of wearables has the potential to be a revolution,” said Kara Dennis, managing director of mobile health at Medidata Solutions Inc., which consults with companies on ways to improve clinical trials.
Drug researchers find this tracking technology is more accurate than human memory gleaned from subjective questionnaires that ask patients to rate their ability to walk on a scale of, say, zero to four. So far, there are at least 299 such clinical trials using wearables, according to the National Institutes of Health’s records.
In one study, GlaxoSmithKline Plc– working with McLaren Applied Technologies, part of the company that makes sports cars — will follow the movements of 25 patients with Lou Gherig’s disease, the muscular neurodegenerative condition also known as ALS. Participants will be outfitted with a small, rectangular light-weight monitor that sticks to their chests, said Paul Rees, medicines development leader at Glaxo. The device, made by Finnish medical technology company Mega Electronics Ltd., measures heart rate as well as walking steps and elevation gain, Rees said.
The biometric data is stored in the device and downloads automatically via a Bluetooth connection when a patient gets near a wireless router about the size of a mobile phone. The hub then sends that data to a secure server Glaxo can access and potentially use for researching much-needed treatments for the disease.
Meanwhile, the Department of Veterans Affairs is preparing to run a clinical trial next February to monitor veterans with back pain. People in pain tend not to be very active because movement inflames their condition, so the department plans to track the veterans’ steps — possibly via a Fitbit, they haven’t settled on the exact device yet. They will input the data, along with other information such as patients’ personal pain assessments, into an algorithm to determine whether they need more or less treatment, said John Piette, senior research career scientist in the department’s Ann Arbor Center for Clinical Management Research in Michigan and one of the lead researchers.
As interest grows, tech companies are seeking ways to make wearables less and less obtrusive. MC10 Inc., a biotechnology company based in Lexington, Massachusetts, has developed one such device called a “biostamp,” an adhesive with flexible circuits and sensors. Co-founder Ben Schlatka describes it as a “lightweight, intelligent Band-Aid” that can be stuck on any part of the body. MC10 has partnered with a number of pharmaceutical companies, though its device isn’t in use in a trial, Schlatka said.
MC10 is partnered with Belgian drugmaker UCB to work on severe neurological disorders. Schlatka declined to name other companies.