In a bid to improve clinical research participation and engagement, the Google Health team announced this morning the launch of a new Android app that streamlines study recruitment for consumers and shows them how survey and sensor data are being employed for health research.
Off the bat, the Google Health Studies app allows users to view a list of open studies and review the inclusion criteria for each. If they are interested, the app runs the user through an e-consent process that they can complete in as little as one minute, Google Health product manager Jon Morgan said during a recent press briefing.
Users who enroll in a study may contribute patient-reported outcomes by completing in-app surveys, or by allowing the app to collect sensor data. During the course of the study or after its conclusion, Morgan said participants will be able to view a breakdown of the data they've contributed individually, such as a summary of their daily mobility data, how their personal demographic is being represented within the enrolled study cohort and the pre-defined outcomes of their particular study.
"One of the core principles that we're building out with the platform is that we want users to be able to see what their contributions have done to research, even if, at the end of a study, for example, there's nothing really found," Morgan said. "We want to close the loop, so we've built in the functionality to be able to share that data back to users, be it interim results or final results from the primary investigator."
Google said that data collected through the app is encrypted, securely stored and only employed for use in the specific study to which a user consented. In addition to giving users a window into the specific information being collected, Morgan said that certain analyses will be conducted locally and then transmitted in aggregate so as to protect participants' privacy.
"We're actually using a very unique secure aggregation tool called federated analytics, which includes querying subsets of phones and then taking those different queries and combining them together," he said. "By the time the aggregated statistics are actually brought together and surfaced to the researcher or surfaced for anyone to see, there is almost no possibility of being able to go back and see individualized data. The individualized data is never leaving the device. It's always inferred statistics."
The first study putting Google's app through its paces is the Respiratory Health Study. A partnership between Google, Boston Children's Hospital and Harvard Medical School, the investigation will use survey responses and mobility data to better understand the transmission dynamics of respiratory pathogens such as COVID-19 or influenza.
Dr. John Brownstein, professor at Harvard Medical School, chief innovation officer at Boston Children’s Hospital and a lead on the study, said during the press event that the team is hoping to recruit roughly 100,000 participants to a six-month participation period spread over the course of the next year. These individuals will be recruited from those who have download the app, as well as through online marketing.
Data from these participants will help researchers glean a better understanding of risk factors, transmission dynamics and testing frequencies for these acute respiratory illnesses than before, he said. For COVID-19 in particular, Brownstein said the study will also give researchers a unique view of how these measures will change as more and more of the population is inoculated with upcoming vaccines.
"We've run a couple survey-type participatory crowdsourcing tools like FluNearYou and COVIDNearYou, but the level of detail that we get is very high level, ... maybe ZIP code-level data," he said. "We don't get details on user behavior, on location. We don't get detailed demographic data, and certainly we don't get the level of testing data. But more importantly, we don't have information on specific locations and settings where people are moving, and we don't get activity data – so a lot of missing elements when you're trying to create a cohort to understand transmission.
"We've basically deployed our historical learnings of survey-based tools for respiratory disease, but deployed them into this research environment, which will give us this real-time view of information in the population [and] give us granular information about risk factors and transmission dynamics," he said.
The Google Health Studies app is available for free download now. The Respiratory Health Study is open to adults living in the U.S.
WHAT'S THE IMPACT?
A substantial number of clinical trials are either delayed or fail entirely as a result of inadequate recruitment. Smartphone-based recruitment strategies that lower the barrier to entry with straightforward enrollment could help research organizations pump up their numbers, Brownstein said. Similarly, an approach that is transparent with data, shows users the impact of their participation and employs well-established digital engagement practices, such as push notifications, could also ensure that more participants are retained through the course of the study, he said.
Brownstein and the Google Health team also took the time to address the issue of participant diversity. This is an area that Brownstein admitted has been a point of criticism for his team's digital data collection projects in the past, as well as the subject of academic criticism.
To combat this, Morgan said the Google Health team included standardized user experience features like larger text and talkback, which can be helpful for older or less tech-savvy participants. To encourage participation across minorities or other groups, he highlighted the data visibility features that show users whether or not their demographic is currently overrepresented or in high demand for each study.
When it comes to analyzing these data, Brownstein noted that the number of potential participants and the variety of demographic data that will be collected for each. With these information, researchers will have the ability to quickly understand whether or not their cohort is representative of a population.
THE LARGER TREND
The Google Health Studies App is a clear counterpart to Apple's Research app, which it launched to iOS users in November 2019 as a hub for its ongoing longitudinal health studies. These research projects were similarly designed in conjunction with big names in healthcare and academia; however, some of these trials extend their data sources beyond the smartphone to an accompanying Apple Watch device, whereas the Google platform's current design limits its sensors to what's included with the smartphone.
Outside of the mobile market's heavyweights, others are also looking to deliver new clinical data streams via smart devices and wearables. Evidation Health is a major name in this arena having worked with names like Johnson & Johnson, BARDA, the Gates Foundation, Eli Lilly and Apple to power health research with connected devices, and just this summer closed a Series D funding round. A number of other startups are also working with the pharma industry to enable digital clinical trials, a list that includes names like Deep 6 AI, Clinical Trial Connect, SubjectWell and PatientWing.