This week, we will witness liftoff for a new National Institutes of Health (NIH) initiative that strives to move our current state of research to a future state of precision medicine where data is broken out of siloes. Researchers will have novel opportunities to study the data, which could speed medical breakthroughs.
I’ve had the privilege of seeing the All of Us Research Program grow from a kernel of an idea into a path-breaking program that ambitiously aims to gather data from 1 million or more diverse people—healthy and sick—living in the US. The information gathered through this program could accelerate research, improve health, and advance precision medicine. It has the potential to transform many aspects of the research paradigm by turning patients into partners, and by converting data into opportunities for all scientists, even citizen scientists, to study and push forward.
The All of Us program stands on the shoulders of the Framingham Heart Study, a 70-year-old, ongoing study that was launched by the NIH under the direction of the National Heart, Lung, and Blood Institute. Starting with the original cohort, the heart study has accrued five more cohorts over the years. It has provided vast quantities of data, which has helped researchers to look for patterns. This has led to important publications and critical advances in our understanding of cardiovascular risk factors and the effects they have on heart disease.
Even the word Framingham evokes a sense of progress, partnership, and participation by real people who unselfishly signed on to create scientific progress for all. I expect that All of Us has already done much due diligence to determine how to evolve the model by incorporating leading practices from Framingham and moving them forward.
The future is coming…and we are ready
We tend to wring our hands over the present in biomedical research and all of the challenges we see today. But we also like to alert everyone that “the future is coming.” The All of Us study is optimistic about the future and what is needed to meet it. It is rooted in the notion that all people should be invited to join in research, and that all researchers should ponder what that data can offer. Meeting the future takes effort. Changing paradigms is hard and might be relentless—so a dose of optimism can make the task easier.
The to-do list to start up this project was extensive. First, a new way of engaging participants had to be created because this effort is fundamentally different than traditional clinical trials. The virtual bricks and mortar of the research infrastructure had to be built to allow for the depth of data collection (e.g., EHRs, biosamples, surveys), and collaboration across multiple institutions had to occur. We know that we need more collaboration to advance research, but getting there can be difficult and involves legal agreements, contracts, and many conference calls. Creating this infrastructure within one institution is no small feat, but spanning it across the US is a different challenge…and opportunity.
Early days indeed, but as one All of Us tagline tells us “the future of health is coming” and all of us should be thinking about how to participate and hasten its arrival. It’s often easier to be a bystander with an opinion. I have witnessed firsthand in my work and personal life how many people and patients want to help build the future by participating in research.
My dad participated in a clinical trial for AML leukemia. He knew it was unlikely to change his outcome, but he understood that his participation could very well help the next generation of patients who were diagnosed with the same condition. As a career military officer, he had a drive to be of service, and participating in that trial gave meaning to his dreadful and aggressive disease. Accruing participants to build this million-person cohort is at the core of All of Us. Over time, this type of data set might actually change the face of how data collection, research, and the return of data gets done. It could lead to a different and easier way to access clinical trials for patients like my father.
The All of Us program is being led by Eric Dishman, who with his team has advanced the program logistically, but also conceptually. In speeches, he often shares his own journey as a patient, and explains how that has been his true north in pushing forward on the All of Us vision. He explains that we are indeed moving to a day where every patient will be able to realize the benefit of a precision medicine approach that accounts for individuals and their uniqueness—instead of a one-size-fits-all approach to medicine. But it is likely only through efforts like All of Us that the system will push closer to that possibility by giving us the data to study and to act on.
What’s next? Read up on All of Us and learn about the type of research opportunities it offers. Consider spreading the word about the launch, asking questions about how it works, pondering scientific use cases, and putting them out for discussion. Think about ways to meet the future using this cohort and others out there. Your involvement, engagement, and ideas could benefit all of us.