All of Us Research Program
Until now, the treatment and prevention of disease has been based on a ‘one-size-fits-all’ approach, with most therapeutics tailored for the ‘average patient’. While this approach may benefit some, it often proves ineffective for others. However, advances in genomic sequencing, mobile technologies and increasingly sophisticated informatics are ushering in a new era of precision medicine. This new approach takes into account differences in people’s genes, environment, and lifestyles giving medical professionals resources to design targeted treatments and prevention strategies for the individual.
In 2015, President Obama announced that he would be launching the Precision Medicine Initiative (PMI), “a bold new research effort to revolutionize how we improve health and treat disease.”
The goal of the PMI, as outlined by the White House, is “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.”
As part of the PMI, the All of Us Research Program seeks to enroll one million or more U.S. volunteers by 2020 in a long-term research effort. Participants will provide a variety of data including information from their electronic health records, health questionnaires, and mobile health data on lifestyle factors and environmental exposures, and may be asked to undergo a baseline physical evaluation and provide blood and urine samples. By doing so, participants will enable researchers to translate the information collected from the cohort into new medical knowledge and treatments. Importantly, the participants themselves will have access to their study results as well as summarized data from across the cohort.
The All of Us Research Program represents a far-reaching and transformative effort to extend precision medicine’s success to a wide spectrum of diseases including some cancers and many chronic diseases such as diabetes, heart disease and Alzheimer’s, as well as mental illnesses like depression, bipolar disorder and schizophrenia. In addition to focusing on disease, the program will study ways to increase and maintain overall health. From a research perspective it fosters open and responsible data sharing with the highest regard for participant privacy and engagement.
Participants may enroll in the All of Us Research Program in one of two ways:
- Through selected Healthcare Provider Organizations (HPOs) that have existing relationships with potential participants
- As direct volunteers, through The Participant Center
The Participant Center has been awarded to Scripps Translational Science Institute (STSI) through The Scripps Research Institute. Together with a network of high-profile partners, STSI will develop, test, maintain and upgrade, as needed, All of Us Research Program mobile applications. These apps will be used to enroll, consent, collect data from and communicate with All of Us Research participants. The Participant Center will also develop parallel platforms to deliver these same functions to those without smartphones.
In addition, the Participant Center will help coordinate all direct volunteer enrollment and engagement activities, including physical evaluations and biospecimen collection.
The All of Us Research Program is currently conducting beta testing in select locations across the country.
Scripps Translational Science Institute
The Scripps Translational Science Institute (STSI) was founded in 2006 with one essential aim – to individualize healthcare by leveraging the remarkable progress being made in human genomics, and combining it with the power of wireless digital technologies. By recognizing that every patient is unique, individualized healthcare tailors medical care to the individual patient, taking into account not only a person’s genes, but also their environment, behavior, and lifestyle. By bringing together basic scientists and clinical investigators, STSI fosters highly collaborative, multidisciplinary research with the greatest potential to transform the practice of healthcare and improve human health.
In 2012, STSI established a Division of Digital Medicine, which has developed into an internationally recognized leader in all aspects of the clinical implementation of wireless technologies in health and healthcare, including how they can be best utilized to better individualized all aspects of maintaining wellness.
STSI Publications on Precision Medicine
- Individualized Medicine from Prewomb to Tomb, Eric Topol, Cell
- Can Mobile Health technologies Transform Health Care?, Steven Steinhubl, Evan Muse, Eric Topol, JAMA
- Digital Medical Tools and Sensors, Eric Topol, Steven Steinhubl, Ali Torkamani, JAMA
- The emerging field of mobile health, Steven Steinhubl, Evan Muse, Eric Topol, Science Translational Medicine
- A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors, Cinnamon Bloss et al., PeerJ
- Moving From Digitalization to Digitization in Cardiovascular Care, Steven Steinhubl, Eric Topol, JACC
- Novel Wireless Devices for Cardiac Monitoring, Joseph Walsh, Eric Topol, Steven Steinhubl, Circulation
- Privacy and security in the era of digital health: what should translational researchers know and do about it?, Barbara Filkins et al., American Journal of Translational Research
- Medicine’s next step, Barack Obama, The Boston Globe
- President Obama’s 1-million-person health study kicks off with five recruitment centers, Jocelyn Kaiser, Science
- Obama Seeks To Make Mark On Genetic Medicine, Matthew Herper, Forbes
- Scripps Research gets record $120M to change medicine, Gary Robbins, San Diego Union-Tribune
Precision Medicine Initiative, PMI, All of Us, the All of Us logo, and The Future of Health Begins With You are service marks of the U.S. Department of Health and Human Services.