FDA rejects Verily’s filing for wearable Parkinson’s disease clinical trial tool

The FDA has rejected Verily’s Parkinson’s disease-focused clinical trial tool designed to evaluate the effectiveness of certain interventions, on the premise that it has limited ability to capture the full picture of a patient’s capacities.

The tool, dubbed the Virtual Motor Exam for Parkinson’s disease, runs on the FDA-cleared Verily Study Watch and was designed to digitally assess a patient’s motor abilities during clinical trials. Researchers designed the tool so that it could give an estimate of the patient’s motor abilities based on the MDS-UPDRS Part III test, which the company called the “gold standard” in Parkinson’s testing.

According to Verily’s Letter of Intent to the FDA, users would be able to complete an assessment made up of eight motor tasks at home. Verily pitched the new tool as a way to conduct evaluations more frequently and in a real-world setting.

However, the agency rejected the tool on the premise that it had a “limited capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”

“For example, a change in rigidity or finger tapping in the MDS-UPDRS Part III [the standard test for Parkinson’s disease] cannot be directly interpreted as being meaningful to patients. However, a change in speech, eating and dressing (as assessed in the MDSUPDRS Part II) represents meaningful change in how patients function in daily life,” Dr. Elektra Papadopoulos and Dr. Teresa Buracchio, deputy directors at the FDA, wrote in the rejection letter.

The FDA also had issues with the feature’s algorithm being used to interpret “meaningful changes in patients’ ability to function.”

“For example, it is unclear how the change in the digital signature for finger tapping (as measured by the Verily Study Watch) could be interpreted as representing meaningful change in patient function,” Papadopoulos and Buracchio wrote.

WHY IT MATTERS

Parkinson’s disease is a motor system disorder that can lead to the loss of control and movements in the body. According to the NIH, there are no cures for the disease, however, medications can be used to treat the symptoms of the condition.

The Parkinson’s Foundation estimates that around 60,000 Americans are diagnosed with the condition each year and that 10 million people worldwide are living with Parkinson’s disease.

Increasingly, researchers and scientists are looking for ways to treat the condition, and real-world data has emerged as a way to gather additional information about the progression of the disease.

THE LARGER TREND

Verily was founded in 2015 as Alphabet’s life science subsidiary. In 2017 the company introduced the Verily Study Watch, a wearable device designed specifically for research and clinical trials.

In 2019, Verily landed an FDA 510(k) clearance for its new feature on the Study Watch, which was able to capture, record, store and display single-channel ECG rhythms.

Verily’s sister company Google has also been interested in the wearable space in recent years. In January Google finally completed the acquisition of wearable giant Fitbit for more than $2 billion.

While Fitbit’s wearables have been used in studies in the past, the primary focus is still as a consumer wearable, whereas Verily’s Study Watch is very much dedicated to research and is a prescription-only device.


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