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Nearly 300 Drugs Being Studied With Wearable Gadgets in Clinical Trials

It’s an effort to bring drugs to market faster and to provide real-world data

Nearly 300 ongoing clinical trials are using wearables such as Fitbits to help gather data, according to National Institutes of Health records. Pharmaceutical companies are using such gadgets in conjunction with drugs as a way to bring their products to market faster.

Bloomberg notes that pharmaceutical 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, for instance, ask patients to rate their ability to walk on a scale of 0 to 4.

In one study, GlaxoSmithKline (GSK) — working with McLaren Applied Technologies, part of the company that makes sports cars — will follow the movements of 25 patients with amyotrophic lateral sclerosis. Participants will be outfitted with a small, rectangular, light-weight monitor that sticks to their chests, said Paul Rees, medicines development leader at GSK. 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 GSK can access; the company can potentially use the data 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; it hasn’t settled on the exact device yet. Researchers 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.

 “What a lot of these consumer-focused companies have done is made pedometers and sensors easy to wear,” Medidata’s Dennis said. “They look cool, they’re slick, they have long battery life, they’re light.”

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.

Source: Bloomberg; September 14, 2015.

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