When Apple introduced the latest iteration of its Apple Watch earlier this month, it was hailed by an unlikely source: FDA Commissioner Scott Gottlieb.

“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” Gottlieb said about the tech company’s freshest entry into the world of wearables.

In what may be the first of its kind, the newest Apple Watch offers two FDA-approved apps: one an EKG and the other a pulse monitor, both designed to detect atrial fibrillation and heart arrhythmia.



For some, the FDA’s embrace of these apps is further proof that the revolution in consumer electronics may finally be coming to clinical trials.

“The obvious benefit is that people are already using it. That’s a big plus. Compliance is going to be built in,” says Sofija Jovic, an advisor at MedAvante-ProPhase.

In the seven years since the first smart phone hit the U.S. market, the percentage of people who own one has more than doubled, according to a recent survey by the Pew Research Center. More than three-quarters of Americans now own a smart phone of some kind, Pew reports.

Wearable devices such as the Apple Watch seem like they may be the answer to long-vexing recruitment problems: the average clinical trial requires 11 site visits and soaks up hours of participants’ free time.

Wearables offer a chance to harvest massive amounts of data without the time-suck — and, in some cases, the gadget itself can be a recruiting tool.

For example, AOBiome recently gave patients in a skin treatment trial cell phones – and had them take photos of their acne and send them to researchers digitally.

The trial was coordinated by the telemedicine company Science 37.

“We’ve built a technology platform to support doing clinical research so that trials can be centered around patients in their homes,” says Belinda Tan, Science 37’s founder.

“Participants don’t need to drive four hours to a university to go to a trial every other week,” she adds, noting that she believes wearables may also help boost diversity in clinical trials.

The revolution is already well underway.

In March, Swiss pharma giant Novartis announced a deal with Science 37 to conduct at least 10 wearable-assisted trials over the next three years.

That doesn’t mean that sponsors and sites can shed their brick-and-mortar clinics, though.

Jovic says that writing a wearable, mobile device into a protocol presupposes enrolling people already comfortable wearing gadgets — which may limit recruiting to people who already have or are familiar with such devices or can afford to buy them if not provided as part of a trial.

Jovic notes there are also some concerns about privacy and informed consent. “Is there such as a thing as too seamless data collection?” she wonders.

Mobile devices are so good at tracking data subtly that most consumers forget that it’s happening. Whatever problems that raises for the larger society, it’s a lot more troubling in a clinical trial context.

“You want some visible way,” Jovic says, “in which people continue to give consent.”

In an effort to keep pace with the Digital Age, the FDA has asked Congress to set aside money in the fiscal year 2019 budget for what it’s calling a Center of Excellence for Digital Health.

Gottlieb says the center will be designed to help the agency deal with lingering questions and craft regulations to adapt to wearables in clinical trials and public health.

Clinical Trials: There’s an App for That

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