FDA to Examine Possible Apple Watch Role in Drug Development

July 16, 2019, 6:26 PM

Can the pharmaceutical industry use Apple Watches and other wearable sensors to speed drug discovery? That’s what one Singapore startup is claiming, and what the FDA is hoping to find out.

The Food and Drug Administration’s drug center is funding a study by Yale University and the Mayo Clinic to see if patient information generated by an Apple Watch can provide the quality of data in a heart failure study needed to make regulatory decisions, according to a July 16 announcement.

Researchers are also testing whether data endpoints—the thing being measured to determine objectively if what’s being studied is beneficial—that aim to capture physical function and quality of life can serve to make regulatory decisions about drugs instead of relying on typical clinical endpoints from a controlled environment.

The study is one of the first tangible steps in testing the use of real-world data to make regulatory decisions and putting patients at the center of drug development. The push by the agency toward greater use of real-world evidence and patient-centered drug development reflect both FDA priorities and legal requirements in the 21st Century Cures law (Pub. L. 114-255) and the latest agreement for user fees, which the FDA collects from medical product developers to review their products.

In the study, patients will wear both an Apple Watch and a medical device called Everion. Developed by Swiss-based Biovotion AG, Everion captures data such as heart rate, skin temperature, respiratory rate, and blood oxygenation in a way that mirrors how those data points would be captured by doctors in a clinical setting.

BiovitalsHF, a mobile health platform, will be monitoring the data and using machine learning to sync physiology data from the sensors with outcomes reported from the patients who are wearing them, such as adherence to medications.

Going Mobile

“There isn’t great evidence of how to leverage the mobile technologies for clinical trials, especially sensor-based technology and how it can be incorporated as part of the clinical trial process,” Nilay Shah, an associate professor of health services research at Mayo Clinic who’s heading up the research, said in an interview.

“We are hoping we’ll be able to generate the initial insights into the extent to which these sensors can be used as part of clinical trials,” Shah said.

Tanisha Carino, executive director of think tank FasterCures, said it was encouraging to see this study get underway.

“Patient data is a critical tool in ensuring treatments are appropriate, personalized, and in this case, getting into the hands of those who need them more quickly. Leveraging the combination of technology and patient-centric outcomes holds tremendous promise for the entire system,” Carino told Bloomberg Law.

Today, the current methods for capturing data points for heart failure in the clinic are expensive, isolated measurements, Kuldeep Singh Rajput, chief executive of Singapore startup Biofourmis, said in an interview. The sensors and platform developed by his company could allow continuous data capture using surrogate endpoints that could stand in for clinical ones such as measuring the intensity of activity, cadence, and step count.

It’s too early to tell how FDA will use the information from this study, Shah said. But it will provide some information on how reliable the sensors are, how reliable the data they collect are, and how well they correlate with other measures used to determine safety and effectiveness of a drug.

“More than anything, this is getting some initial experience with different approaches to data collection as part of a clinical trial,” Shah said.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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