San Diego, California - As part of the most ambitious medical research program in the history of American medicine, The Scripps Research Institute (TSRI) has received an initial award of $20 million for its role in a national precision medicine initiative, the National Institutes of Health (NIH) announced.
“We are thrilled to have the opportunity to help lead this far-reaching, transformative program of one million or more U.S. participants with long-term follow up,” said the new grant’s principal investigator Eric Topol, MD, who is director of the Scripps Translational Science Institute (STSI), professor of genomics at TSRI and chief academic officer at Scripps Health. “Our focus at STSI for the decade of its existence has been to advance individualized medicine. Using genomics, mobile apps and biosensors and providing data back to each participant, this study will set the foundation for new medical knowledge and ways of engaging people in research as citizen-scientists.”
“This grant, which will total almost $120 million over five years, is one of the largest federal grants ever awarded to TSRI,” said TSRI CEO Peter Schultz, Ph.D., “and it represents the expanding leadership role that Eric and TSRI will play in this new era of biomedical research.”
More than 1 million participants
The five-year award is part of the Cohort Program of President Obama’s Precision Medicine Initiative (PMI); the PMI Cohort Program is a landmark longitudinal research effort that aims to engage one million or more U.S. participants to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics.
“STSI already has played a pivotal role in a digital medicine revolution that is radically transforming the way we think about and provide health care,” said Chris Van Gorder, president and CEO of Scripps Health, which operates STSI in partnership with TSRI. “This grant ensures the continuation of that work for years to come on a scale that will benefit the entire nation.”
The new grant will support a Participant Technologies Center through STSI that will play a key role in enrolling participants in the study, as well as providing mobile applications. In parallel, the center will develop platforms to deliver these same functions to those without smartphones and work with various technology organizations to increase smartphone accessibility.
STSI has partnered with the NIH-funded Vibrent Health of Fairfax, Virginia, which will provide the technology platform to enroll and engage participants through mobile apps, web app, interactive voice response, feature phones and wearable sensors; Vibrent Health will develop, test, maintain and upgrade the technology platform to enroll, consent, collect data from, communicate with and retain participants throughout the grant period.
In addition, Seattle-based Sage Bionetworks, an integral partner in the design, development and data hosting for many of the mobile-app-based research studies on Apple’s open source ResearchKit platform, will be responsible for developing symptom measurements from phone, wearable and other sensors, as well as community outreach and participant engagement efforts with the Participant Technologies Center.
The initiative also includes an extensive network of high-profile partners including Walgreens and PatientsLikeMe. Working collaboratively with other entities, the Scripps Participant Technologies Center will be responsible for enrollment of at least 350,000 participant-volunteers.
“These partners provide unparalleled outreach and engagement, along with data privacy and security capabilities,” Topol said.
The team aims to begin initial enrollment into the study this year, with the aim of meeting its enrollment goal by 2020.
Mobile device engagement
Participants will be invited to answer questions about their health history and status, share their genomic and other biological information through simple blood and urine tests and grant access to their clinical data from electronic health records. In addition, mobile health devices and apps will provide lifestyle data and environmental exposures in real time. All of this will be accomplished with essential privacy and security safeguards. As partners in the research, participants will have ongoing input into study design and implementation, as well as access to a wide range of their individual and aggregated study results.
“This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease,” said NIH Director Francis S. Collins, M.D., Ph.D. “Over time, data provided by participants will help us answer important health questions, such as why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health, and how people suffering from a chronic illness can maintain the highest possible quality of life. The more we understand about individual differences, the better able we will be to effectively prevent and treat illness.”
The knowledge gained from the PMI Cohort Program will extend successes of precision medicine in some cancers to many other diseases. Importantly, the program will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout life.