All of Us Research Program, formerly called the PMI Cohort Program, is making great progress. Thus far we have completed the planning, piloting and prototyping, and development phases of the program. We are now about to launch the first version of the protocol and begin enrolling participants.

When we started the program, we had to consider the tradeoffs of launching quickly with limited capabilities (e.g., simply surveys, limited infrastructure) versus waiting to launch when we had a greater capacity to collect and process more information (e.g., electronic health records, biospecimens). We initially thought that enrolling the first 100,000 participants quickly when there was a lot of excitement about the program made the most sense. However, after talking with our partners, advisors, and potential participants, we changed our minds.

We funded a pilot phase of 5,000 people to give us feedback, and also started to conduct workshops and focus groups around the country with diverse populations traditionally underrepresented in biomedical research (e.g., rural populations, racial and ethnic minorities).

From these discussions it quickly became clear that “first impressions are everything” and it would be better to build a deeper, rich platform and protocol than start quickly with simple surveys.

We decided to focus on building out the protocol, diversity engagement plans, and direct volunteer and health care provider organization networks to be able to start biospecimen collection, electronic data sharing, and other aspects of the program.

Launching such a large research program is not without its challenges. Some of our major challenges include:

• Bringing together multi-disciplinary teams across multiple sites. This includes over 60 partner organizations, including government agencies, nonprofit organizations, and academic institutions.
• Achieving diversity and building trusted long-term relationships with people, especially from within communities that have been left behind in traditional biomedical research.
• Including participants as partners in governance and citizen science as the program continues to grow. For example, we need real participants in the program before we make key decisions on how and when to return genetic information.
• Creating robust datasets that include electronic health record data from direct volunteers – who may have many providers – and behavioral data from activity monitors and other wearable devices.

All of Us currently has 64 partners working to build a more in-depth version of the platform, plan, and protocol. Many of these are health care provider organizations across the country that are training and getting ready to enroll participants. Additionally, we are currently gearing up to start enrolling direct volunteer participants.

The first version of the protocol is under final review with the All of Us central Institutional Review Board (IRB). We are in the process of doing security and user testing on our platform. Once we get final IRB approvals for our website and materials, we will launch a controlled Beta phase in May. We will enroll the first 25,000 participants and, based on their experience and feedback, we will make updates and improvements to the program. Once all systems are up and running smoothly, we will launch nationally. Our national launch is planned for fall 2017.

The Precision Medicine Initiative (PMI) is a bold new research effort that seeks to change how we improve health and treat disease in the United States. PMI is a collaborative effort involving agencies across the Federal Government, including the Department of Health and Human Services, the Department of Veterans Affairs, the Department of Defense, the Department of Energy, and the National Institute of Standards and Technology. Public and private stakeholder organizations are also partnering in this landmark initiative.

The All of Us Research Program is one part of PMI. All of Us is an ambitious effort to gather data from 1 million or more people living in the United States to accelerate research and improve health. The program will be open to people both healthy and sick, from all communities. Participants may enroll through participating health care provider organizations or through our website or mobile app.

Assuming we get IRB approval and our security tests are successful, our first major milestone is to launch the Beta phase of the All of Us Research Program in the next month. As part of the Beta test we will be learning and sharing the results of different approaches to recruiting populations that have traditionally been underrepresented in biomedical research.

As we begin testing the entire enrollment process with early participants, we will continue planning – with a lot of input from all sectors of the scientific community – for other aspects of the program, including how we approach genomics and the best approaches for returning information to participants.  We are also in the process of developing plans for recruiting special populations, starting with children and Native Americans / Alaskan Natives.

Later this year, after we have fully tested the platform and the user experience at each of our enrollment sites and through the online portal, we will launch nationally.

The 21^st Century Cures Act includes $1.455 billion in funds to the All of Us Research Program over ten years, which are no-year funds. This provides flexibility for when the funds are obligated. In some fiscal years, we will utilize this flexibility to appropriately manage the program while ensuring the proper stewardship of federal funds. However, without an increase in base funding, we will need to slow the pace of enrollment and data collection, change its scope, and/or rely on public-private partnerships to support some of the needs of the program.

If there are budget cuts, then we will have to make tradeoffs with some of our program activities. It will take longer to enroll 1 million participants, we will have to do the genotyping and other genetic analyses later, and it will take more time to collect new data types like imaging and wearable devices. However, we will continue to remain committed to our core values of having a diverse set of participants; allowing participants to enroll directly through our website or mobile app; and providing open data to a broad range of researchers from citizen scientists to investigators in academia and industry. Similar adjustments would also have to be made for other Cures-supported initiatives.

We are confident in the importance of the All of Us program to stay internationally competitive, and we are hopeful it will get done with great bipartisan support.

There are many key aspects of the Precision Medicine Initiative that could benefit the broader public health community. Some of the most important are:

• Deliver value to participants. Patients and others who enroll in research studies have a right to access their data, and to the responsible return of results – we need to adjust our policies, practices, and technologies in health care to deliver that to patients and research participants.
• Embrace security and privacy challenges. We must stay vigilant about securing the confidentiality and privacy of people’s data. All of Us is following the “PMI Data Security Policy Principles and Framework” and “PMI Privacy and Trust Principles” developed by many stakeholders when PMI launched.
• Liberate the data. While we continue to implement strong safeguards to secure the confidentiality of health data, we are moving toward a world where making data more open (instead of hoarding) to a broader set of researchers, including citizen scientists, is becoming the new normal. This means understanding what researchers, from all backgrounds, need to answer some of our most vexing health questions. It also means exploring new models of data access, taking advantage of technology, and shifting the incentives for researchers to ones that encourage responsible data sharing.
• Bring in diversity. The whole research ecosystem needs to take seriously the idea that we need more diversity in our research studies. Too many people have been left behind and too much science has been left undone. To truly deliver on the promise of precision medicine for all of us, we must reflect the people that live in the United States in large-scale research efforts like this one.

All of Us is an exciting program and we are eager to begin enrolling participants. However, it is important that we launch when all of our systems are robust and fully functional. The All of Us Director, Eric Dishman, has worked in Silicon Valley and most recently served as Vice President and Intel Fellow of Intel Corporation’s Health & Life Sciences Group. His expertise on user-centered design and platform development ensures that we are building platforms that are valuable and ready to expand in the future.

We are committed to transparency and will keep participants, researchers, and the public updated on the news, events, and progress of the program. We will continue to provide updates at our website (AllofUs.nih.gov). And of course look for news and announcements from our Director’s Corner.

The scientific opportunities with a research platform of this scale, diversity, and data are enormous. All of Us can help us find the right drug at the right dose for the right patient, better assess the risk and progression of diseases based on our unique genetic makeup, and understand what prevention methods work and for whom. It can help us find new ways to treat diseases by identifying genetic mutations that protect against common diseases, and discovering the factors that protect people who should be ill but appear disease free. The program will also provide a platform for identifying new ways to evaluate wearable devices and other technologies to prevent or manage chronic disease.