Alphabet-owned research and engineering firm Verily Life Sciences has launched an ambitious clinical trial in partnership with Duke University School of Medicine and Stanford Medicine that will collect health data from approximately 10,000 participants who each will be followed over the course of at least four years.

The Project Baseline study will collect broad phenotypic health data, which involves observable characteristics of an individual resulting from the interaction of his or her genotype with the environment.

The study’s data repository will be built on Google computing infrastructure and hosted on Google Cloud Platform, which, Verily said, meets rigorous compliance standards that test for data safety, privacy and security. 

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The study is the first initiative of Project Baseline, a broader effort designed to develop a baseline, of health as well as a robust data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease. Beyond this first effort, Project Baseline will test and develop new tools and technologies to access, organize and activate health information.

“With recent advances at the intersection of science and technology, we have the opportunity to characterize human health with unprecedented depth and precision,” said Jessica Mega, MD, chief medical officer at Verily. “The Project Baseline study is the first step on our journey to comprehensively map human health. Partnering with Duke, Stanford and our community of collaborators, we hope to create a dataset, tools and technologies that benefit the research ecosystem and humankind more broadly.”

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The Project Baseline study will begin enrolling participants at the Stanford and Duke study sites within the next few months. Committed study sites include Duke’s sites in Durham and Kannapolis, North Carolina; Stanford’s site in Stanford, California; and the California Health and Longevity Institute in Westlake Village, California. Verily’s scientific executive committee also is exploring additional study sites across the United States.

Each site will gather datasets on participants through repeat clinical visits; daily use of a wrist-worn investigational device and other sensors; and regular participation in interactive surveys and polls by using a smartphone, computer or call center. Data collected will include clinical, imaging, self-reported, physical, environmental, behavioral, sensor, molecular, genetic and other health-related measurements. Biospecimens collected will include blood and saliva, among others.

One of the focus areas of the Project Baseline study is participant involvement, which includes development of a participant committee and the option to receive certain health data and test results, participate in conference calls with members of the study team, and evaluate new tools and technologies.

“Through the Project Baseline study, we are aiming to engineer a true 21st century approach to health – in a preventive and personalized way,” said Adrian F. Hernandez, MD, professor of medicine at Duke and member of the Duke Clinical Research Institute. “Instead of having the annual physical exam that has not changed in decades, we’re hoping to develop new platforms that will discover changes in health as they happen in meaningful and actionable ways. To do this successfully, we will partner with participants to learn and deliver the best approaches for every aspect of the study.”

Currently, most of what treating physicians see are short snapshots in time of an individual, primarily after he or she already is ill, said Sanjiv Sam Gambhir, MD, chair of radiology at Stanford and director of the Canary Center for Cancer Early Detection.

“We are effectively missing a lot of valuable information years prior to illness,” Gambhir said. “We’re dealing with illness in the absence of a well-defined reference of healthy biochemistry, and this underscores the criticality of what we hope to achieve here. By focusing on the health of a broad population, we can eventually have a meaningful impact on the well-being of patients around the world.”

De-identified Project Baseline study data will be available to qualified researchers for exploratory analysis in the future. Initial research goals include characterizing the variation in the observed physical and biochemical traits of the study population, or phenotypic diversity, and identifying biomarkers of disease-related transitions, including those related to cardiovascular disease and cancer.

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com

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