The National Institutes of Health’s precision medicine initiative, All of Us, has begun enrolling beta testers, according to the program’s director, Eric Dishman.
In July 2016 the research program assembled a consortium of universities, medical centers, and technology companies to enroll participants and collect data and blood and urine samples.
With a goal of enrolling one million or more volunteers, the program is expected to have the scale to enable research for a wide range of diseases, as well as increase our understanding of healthy states. Additionally, a research program of this size will have the statistical power to detect associations between environmental and/or biological exposures and a wide variety of health outcomes.
DIshman said the program has completed preliminary pilot studies and focus groups to learn from members of the public about their interests and questions concerning research participation. “We’ve developed a research protocol, including an initial set of surveys. We’ve invested in a state-of-the-art biobank and built “big data” IT systems to transfer and store data, with safeguards in place to keep participants’ information private and secure,” Dishman wrote in an NIH blog post. Now it has embarked on beta-testing with participants using the first iterations of its research protocol and technology systems.
All of Us is starting small, beginning with one site and gradually expanding to more than 100 sites nationally during the beta phase. Partners will begin testing on a staggered schedule through early fall, each enrolling a handful of participants a day to start, and inviting more when ready—eventually totaling at least 10,000 people across the country.
Dishman said the beta testers would help the program find problems with its systems and processes, so it can fix them and improve the experience for everyone going forward.
Once testing is complete, All of Us will kick off a national launch anticipated for late fall or early next year. Ultimately, the goal is to build a community of at least one million people.
NIH notes that among the scientific opportunities presented by All of Us is the ability to:
· develop ways to measure risk for a range of diseases based on environmental exposures, genetic factors and interactions between the two;
· identify the causes of individual differences in response to commonly used drugs (commonly referred to as pharmacogenomics);
· discover biological markers that signal increased or decreased risk of developing common diseases;
· use mobile health technologies to correlate activity, physiological measures and environmental exposures with health outcomes;
· develop new disease classifications and relationships;
· empower study participants with data and information to improve their own health; and
· create a platform to enable trials of targeted therapies.