Abstract
Verily Life Sciences, Duke University School of Medicine, and Stanford Medicine have announced they will launch a new longitudinal baseline study to provide a platform for further genomic and lifestyle research.
The study, to be funded by Verily, will collect broad phenotypic health data from approximately 10,000 participants, who will each be followed over the course of at least four years. The study will be part of a larger initiative between the three groups, called Project Baseline.
Project Baseline “may have a profound impact” on the future of medicine, said Kenneth Mahaffey, M.D., a professor at the Stanford University School of Medicine and vice chair of clinical research at the Stanford Center for Clinical Research.
“Baseline is different than other programs,” he said, because it will provide a deeper and more comprehensive view of human health and disease—and the transitions from health to disease. “We hope to be able to identify yet-to-be-identified signals or biosignatures that accurately define health, disease, and the potential transitions.”
Dr. Mahaffey said the study might allow for a “a much greater understanding of the biology of disease and identify opportunities for new interventions or therapies.”
According to Dr. Mahaffey, Baseline came about as a culmination of discussions between Andrew Conrad, CEO of Verily (formerly Google Life Sciences), and now an Alphabet company; Rob Califf, M.D., who at the time was a professor of medicine and vice chancellor for clinical and translational research at Duke; and Sam Gambhir, M.D., chair of the radiology department and director of the molecular imaging program at Stanford.
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“Both universities had ongoing projects and realized that embarking on Project Baseline as a strong academic-industry partnership between the three organizations could be quite powerful,” Dr. Mahaffey said.
According to Verily, study sites will include Duke’s Durham and Kannapolis sites in North Carolina, and Stanford’s site in Stanford, California, along with the California Health and Longevity Institute in Westlake Village, California.
Adrian Hernandez, M.D., professor of medicine at Duke, said Duke has been looking for some time for “a 21st Century approach to healthcare,” and they believe Baseline might provide that. The desire was to figure out which biomarkers could predict changes in a person’s health, as early as possible.
The baseline study will track a wide variety of data, including those collected through clinical, imaging, self-reported, physical, environmental, behavioral, sensor, molecular, genetic, and other health-related measurements. Blood, saliva, and other biospecimens will also be collected. The Verily study watch, worn by participants, will track heart rate and other data over time, said Dr. Hernandez. The study participants will range from young to old and have varying degrees of health, allowing for a more predictive way of treating patients, rather than reactive.
Dr. Hernandez said he hopes the study will have a large impact, not only directly on the practice of medicine, but in a complementary way on other research. “We’re hoping to discover new signals to heart disease and cancer.”
Jessica Mega, M.D., chief medical officer at Verily, said Verily conceived the Project Baseline Study with the goal of mapping human health. One of the key features of the work is to develop a data infrastructure for multidimensional datasets to be used as a single query source, she said. “This has not been done before, and really builds on our Google heritage.”
“The study will also evaluate novel tools and technologies that may be used to better understand the transition from health to disease and identify additional risk factors for disease,” Dr. Mega added.
Verily intends for the study to take “a deep and comprehensive view of human health,” according to Dr. Mega. “The molecular, sensor, and software tools and technologies we are developing will seamlessly integrate, organize and activate multidimensional health data from lots of different sources—many of which have never been combined for a single individual. This includes passive sensor technology, such as an investigational wrist-worn sensor, as well as a data analytics platform that provides one query source for all of the data.”
Another aspect of the study includes the emphasis on the participant. Dr. Mega called the study “participant-centric.”
“We have spent a lot of time thinking about how to make the participant experience positive, so that being part of research can be fun and meaningful,” she said. “Participants will have the option to receive certain health data and test results, and we think it’s important to do it in an ethical, responsible manner.”
Beyond a positive experience, Verily will not be providing medical advice to participants. Participants will be encouraged to discuss any questions they have with their physicians, Dr. Mega said.
In the end, Verily is aiming to develop a discovery platform that the scientific community can leverage in the future for exploratory research. Verily plans to make the de-identified data available to qualified investigators around the world for research purposes.
Ultimately, “Project Baseline is a united effort of diverse stakeholders that are all passionate about this important mission,” Mega said.
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