Data is the lifeblood of any clinical trial, providing information on everything from patients’ responses to therapy to adverse events. Many data points are either self reported or show up in routine exams, but increasingly, it’s possible for trial sponsors to take measurements using wearables, thus obviating the need for subjects to go into the clinic so frequently.
Still, the biggest recent news for wearables came earlier this month on the consumer side of the business, with the Food and Drug Administration approval of the Apple Watch as an ECG monitoring device.
Aman Thukral, an associate director for data and statistical sciences at Chicago-based drugmaker AbbVie specializing in devices for clinical development, said in a phone interview that it’s too early to say what sort of role the Apple Watch might play in clinical trials, and there are some downsides as well. For one, the Apple Watch has a relatively short battery life, which is shorter still if running ECG. And in some disease states like cancers, what researchers see is that the battery life if wearable components is a key indicator of how frequently patients use them. Another issue is potential burden on patients because if they only use the ECG component, that means they have to have a mobile phone, which means the drug company has to give the patient a phone in addition to the watch and the mobile phone they may already carry. On the other hand, he added, some startups are developing wearables that only comprise a watch or some small component, which would lessen the burden.
The MedCity ENGAGE conference, which will take place in San Diego Nov. 6-7, will feature a breakout panel, “Leveraging Wearables for Increased Engagement.” The panelists will include Spry Health co-founder Pierre-Jean Cobut, Withings Healthcare VP Alexis Normand and HonorHealth Chief Academic Officer Priya Radhakrishnan, with moderation by Josh Baxt, principal of Baxt Communication.
To be sure, the use of wearables in clinical trials isn’t entirely new. In September 2015, Bloomberg reviewed National Institutes of Health data to find nearly 300 studies were already using them. And a paper published in July in the journal Clinical Pharmacology and Therapeutics by researchers at Takeda Pharmaceuticals International listed several types of wearables already used, including headbands, clothing-embedded sensors, finger-worn devices, cuffs, skin patches and wrist-worn devices.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Attend MedCity ENGAGE to hear about how wearables can improve patient engagement. Save an additional $50 using the MCN50 code. Register now.
But despite growing interest among drugmakers around wearables, their utility varies by demographics, especially in terms of age groups and disease states, Thukral said. As one might expect, younger patients who are more tech-savvy may be more likely to embrace the use of devices than older and less tech-savvy patients. But in terms of disease state, he said, patients whose diseases make them more motivated – such as those that are curable or cause social embarrassment, like psoriasis – tend to warm more easily to wearables than patients who are less motivated because of potentially fatal diseases like cancers. “Oncology patients don’t like anything extra because they are already demotivated and know their time is coming,” Thukral said.
While he declined to share vendor names, Thukral said AbbVie has used wearable devices in its trials for accelerometry, actigraphy and Parkinson’s disease, including consumer- and medical-grade, mostly worn on the wrist, as well as some ankle-worn. All were provided by AbbVie rather than patients being required to “BYOD,” or “bring your own device,” he added
Nevertheless, wearables can be particularly useful because they can provide a less biased result than a doctor visit, such as when measuring blood pressure, blood sugar or lipids. “If you’re sitting with a doctor or nurse, and they’re monitoring your blood pressure, it tends to go up because you’re in a closed environment and experiencing anxiety,” he said. Similarly, patients must be careful not to eat sweet foods for a period when having blood sugar measured for hyperglycemia. But wearables can measure all those things in real time, thereby providing a more useful diagnosis than a once-monthly measurement.
Photo: exdez, Getty Images
UPDATE: This story has been updated to include information about how AbbVie is using wearable devices in its trials.
