Will Google and Apple Compete for Clinical Trial Dominance?

Will Google and Apple Compete for Clinical Trial Dominance?

Snapshot of the new health watch for medical research from Verily Life Sciences

Google officially entered the clinical space with the launch of their Verily Study Watch last month.

One of their driving goals with this device is to help researchers passively capture human health data. Among other things, Verily will use the watch to facilitate the Project Baseline study, an ongoing investigation of myriad human health concerns. Of course, a watch capable of collecting wearers’ data already exists.

Now the question that we can’t stop asking is “How the Verily Study Watch will stack up against the Apple Watch and ResearchKit?”

The Apple Watch and ResearchKit

Revealed in September of 2014, the Apple Watch is a powerful, multi-functional device for tracking movement, sleep, and other personal health data.

The Apple ResearchKit was inspired by a 2013 conversation between Dr. Stephen Friend, founder of Sage Bionetworks and Mike O’Reilly, Apple’s VP of medical technologies, after a presentation Dr. Friend gave at Stanford’s MedX conference.

“Imagine ten trials, several thousand patients. Here you have genetic information, and you have what drugs they took, how they did. Put that up in the cloud, and you have a place where people can go and query it, [where] they can make discoveries,” said Friend.

His ideas of open science and data sharing were not only the foundation of his nonprofit Sage Bionetworks, but also spoke to O’Reilly, who sought Dr. Friend out after the presentation.

Apple’s ResearchKit debuted in March of 2015, following somewhat closely on heels of the Apple Watch. On its website, ResearchKit is described as “an open source framework introduced by Apple that allows researchers and developers to create powerful apps for medical research. Easily create visual consent flows, real-time dynamic active tasks, and surveys using a variety of customizable modules that you can build upon and share with the community.”

The Apple Watch and Apple ResearchKit were naturally a dynamic duo from the start. Since data can be gathered via the Apple Watch and subsequently analyzed and applied through ResearchKit, the combination of the two technologies has shown a lot of potential for passively capturing critical human health data.

Ethical Concerns about Apple’s Approach

There are a variety of benefits to using Apple’s dream team for collecting data for clinical trials. The Apple Watch is a hot commodity, and already worn across the globe for fitness and fashion purposes. Moreover, in the clinical research sphere, numerous types of Electronic Device Report Outcomes (eDROs) technology are becoming more widely utilized by the day.

While wearable tech is convenient on both the potential volunteers’ and researchers’ end of things, there are a number of ethical concerns that have sprung up around use of the Apple Watch and ResearchKit.

This clinical research realm is a bit like the Wild West, an unexplored frontier yet to be fully regulated. A major concern is self-reported criteria such as age.

One reporter for The Verge wrote, “When you open up “Asthma” — one of the five ResearchKit apps released yesterday — you’re asked a number of questions, including about your age. If you say you’re not over 18, you’re ineligible. But answering “yes” to the age question, and going through a few other questions (Are you pregnant? No. Do you live in the US? Yes.) lets you know that you’re eligible for the study.”

Granted, the article was written shortly after ResearchKit’s release, and Apple has undoubtedly spent the last two years working hard as usual. Still, there is a degree of uncertainty when it comes to this type of data. If we start requiring some type of ID scan, how do we match that identification to the device’s owner? How do we prove they aren’t forgetting it at home when they exercise or even lending it to a friend before the friend exercises?

There is no doubt that on-site, monitored clinical trials have limitations, and that the Apple Watch and ResearchKit will prove beneficial in the future; however, we must proceed carefully as we settle the unknown frontier.

How the Verily Study Watch Differs

So is the Verily Study Watch simply a second Apple Watch, late to the party? Definitely not.

Google’s wearable tech rendition is far from a simple knockoff of what came before it. In fact, as of right now, it’s not even going to be offered to the general public.

The Study Watch, true to its name, was built with consideration for the needs of clinical and other observational studies. It was tailored with the user’s experience in mind, and developed with feedback from clinicians, researchers, and users.

Verily Study Watch boasts the following main features:

  • High quality signals
  • Numerous physiological and environmental sensors. These include:
    • ECG
    • Heart rate
    • Electrodermal activity
    • Inertial movements
  • Seamless usage
  • A battery life of up to a week
    • This encourages better user compliance
  • Robust firmware that can enable subsequent extensions such as
    • Over-the-air updates
    • New algorithms
    • User interface upgrades
  • A low-power display that always shows the time
    • Sometimes instructions are displayed
    • No other feedback is given to the user
  • Processor powerful enough to support real-time algorithms on the watch itself
  • Impressive internal data compression and storage
    • Device can store weeks’ worth of data
    • It does not to be synced frequently– another feature that encourages constant wear and compliance

All of the Verily Study Watch’s data is encrypted. It is uploaded and processed through use of Verily’s own back-end algorithms and machine learning tools. The powerful device can store and process large volume of data, which is one of the ways they’ve set themselves apart.

According to the company’s introduction of their new product, “While numerous wearables exist in the market, we have a specific need outside of these offerings: namely, the scalable collection of rich and complex datasets across clinical and observational studies.”

Clearly, Google is breaking into the industry with a powerful bang.

Project Baseline

One of Verily’s goals is the ambitious and ongoing Project Baseline study, an extensive exploration of human health and sickness. Of course, the ultimate goal is to help enhance the former and cure the latter.

Last month, Verily announced that the first project will be a collaboration with Stanford Medicine and Duke University. The study will last four years and hopes to recruit up to 10,000 volunteers in California and North Carolina. The goal is to better identify risk factors for disease and to understand how people transition from healthy to sick.

The participants’ data will be collected via a combination of:

  • Polls and surveys
  • Visits to clinical research sites
  • The Study Watch

Volunteers will even have the option to obtain some of their health results, both for their own knowledge and to share with their physicians if they choose.

“[…] the Project Baseline study dataset will include clinical, molecular, imaging, self-reported, behavioral, environmental, sensor, and other health-related measurements,” wrote Jessica Mega, chief medical officer for Verily, in a recent blog post.

Duke and Stanford are just the beginning of the collaborations with clinical and educational powerhouses that Verily envisions for the future. The company plans to connect with a broad range of partners across everything from academia, science, and medicine, to design, engineering, and the ever more important field of patient advocacy.

It will be interesting to see who is involved next and what findings the studies produce.

Conclusion

So far, it looks like comparing the Apple Watch and the Verily Study Watch might be like comparing apples and oranges… or even two things as different as apples and the kitchen table. While they are of course two somewhat comparable devices, the two companies have different intentions overall.

While the Apple Watch is an impressive piece of technology, it is meant for fitness tracking and everyday wear. When combined with ResearchKit, it becomes a clinical research tool. The Study Watch, on the other hand, is a more niche product. The company has stated the watch is not for sale and is instead jumping headfirst into the research arena. Perhaps as the two evolve, they will become more direct competitors, and perhaps the inverse will occur. As of right now, only time will tell.

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Welcome to Clinical Research Trends, a new blog dedicated to providing breaking news on clinical trial recruitment, patient engagement, new technology and noteworthy trends. With this blog, we are working to provide clinical research organizations, sponsors and leading service providers with critical news and industry updates on a regular basis. If you want to learn more about the latest trends in clinical trial recruitment and drug development, you’ve come to the right place.

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