The Project Baseline Study:
Offering a Unique CONTRIBUTION to Mankind
The Project Baseline study is no less than an ambitious effort to map human health. It came about as the result of discussions that began in 2013 between Drs. Sanjiv (Sam) Gambhir of Stanford, Robert Califf from Duke, and Andrew Conrad (then from Google X, now the chief executive officer of Verily Life Sciences).
Gambhir provides the background: “Google X was looking to undertake a landmark study in human health. I was initially contacted by Dr. Conrad due to my focus on early cancer detection and the potential for studying large cohorts of individuals at low and high risk for cancer. Dr. Califf was brought into the discussions due to his experience in running large cardiovascular trials at Duke. Over the course of many months and several discussions, the study evolved to what is now referred to as the Project Baseline study.”
The Project Baseline study is enrolling approximately 10,000 participants across the United States in an extraordinarily detailed, four-year examination of what it means to be healthy and to identify what happens during a transition to disease.
The leadership at Stanford includes Gambhir, MD, PhD, a professor and chairman of radiology; Kenneth Mahaffey, MD, a professor of cardiovascular medicine and director of the Stanford Center for Clinical Research (SCCR); and Rebecca McCue and Susan Spielman, who wear several hats in the School of Medicine.
Volunteers who elect to enroll are in for a comprehensive two days of tests, says McCue, who is the associate director of the SCCR and oversees site-based research in the Department of Medicine. “The staff who work with the enrollees have prioritized ensuring that their experience is positive and treating them as engaged participants. We’ve focused on that across all the institutions involved since day one as we’ve designed the workflows and the protocol, because we recognize we’re asking the participants to do a lot.”
McCue gives a glimpse of the testing participants undergo: “They get an extensive battery of tests: basic medical history and vitals, electrocardiogram, ankle-brachial index, some physical performance testing, cognitive testing, eye exam, echocardiogram and stress echocardiogram, X-ray, coronary artery scan, audiometry. We’re trying to get a comprehensive view of each person’s health.”
It doesn’t end after two days. Participants will return to their site of enrollment for a visit each year for four years. Some participants will be asked to return quarterly. All participants will receive tools to use, including an investigational study watch designed by Verily that tracks things like heart rate and activity level as well as a bed sensor that reports on quality of sleep. They will also have access via a mobile app to a portal where they will be able to respond to surveys and enter data of their own.
Every effort is being made to enroll a participant population that reflects the US population by age, ethnicity, health status, and other demographic variables, according to Spielman, director of strategic initiatives for radiology. She was involved in project discussions among the three principals from the beginning and currently co-leads Stanford’s strategy and development plans for the Project Baseline study with McCue.
She describes how the enrollment cohort came to be defined: “There’s a broad definition of who we’re targeting, so it allows for an easier recruitment process that is more inclusive and more realistic. Collecting information from a diverse group of people with different health histories is critical to the success of the study. Because it’s so difficult to recruit and retain in research, by redefining the cohort structures we’re able to bring in a bigger range of people more easily and enroll the diversity of the population that we need to be successful.”
Recruitment began in June 2017, and Stanford continues to enroll several new participants every day.
Most sponsors of clinical research studies provide the funding and are otherwise mostly silent partners. In the case of the Project Baseline study, it is the true partnership between academia and industry that makes the study possible, as Spielman explains:
“The mission of the study was developed collaboratively among Stanford, Verily, and Duke. Verily is developing many tools that are enabling us to perform the study as envisioned. As we are doing all these assessments to collect the data at each site, they are creating the necessary infrastructure that allows people to consent and enroll, developing the electronic data capture system for all the data to be entered, and implementing the software platforms for robust multi-dimensional data analyses at a later time.”
The intention is to make data available to anyone with an institutional review board-approved research study in accordance with guidelines established by a committee set up to handle such requests. It will be a tremendous resource for the whole global community.
Both Spielman and McCue express excitement about how well the study is going so far. Spielman recalls that “there were a lot of people who thought the scope was so big and the depth of the data being collected was so comprehensive that there would be many roadblocks. So the fact that we’ve been able to get started and are gaining momentum in enrollment is thrilling.”
It will be a tremendous resource for the whole global COMMUNITY.
McCue concurs, saying, “It’s remarkable how much effort has gone into this study from all sides. It took many years for the collaboration and the study protocol to come to fruition, through the efforts of a lot of dedicated individuals from Verily and Stanford and Duke. I’ve been really impressed by the intensity with which the faculty and everybody across the board have been engaged. What excites me most is seeing how motivated the teams are and how much people believe in the study and want to make something really good come of it.”
Sites at Stanford Medicine, the Duke University School of Medicine, and the California Health and Longevity Institute are currently enrolling. Additional sites may be added over time. Sometime in the coming years, when all approximately 10,000 participants have completed four years of tests and surveys and measurements, a vast treasure trove of data will have been amassed. It will be uniquely capable of answering questions about health and disease that have never been able to even be asked before.