“All of Us” Achieves Substantial Recruitment Milestone in Record Time
In 2015, the U.S. National Institutes of Health (NIH) announced plans for a major precision medicine initiative. The program is designed to take into account individual differences in lifestyle, environment and biology by gathering health data over time from more than a million people across the country. Its ultimate goal is to accelerate medical research and improve health by discovering new information about disease risk, differences in individual responses to drugs, and various other information that could empower people to improve their health. The data gathered via this effort would be made available through a public database, enabling researchers to follow participants’ health records over time. The U.S. Congress authorized $1.5 billion in funding over 10 years to support this effort.
After much planning and pilot testing, patient enrollment for this program, now branded as the “All of Us Initiative,” began in May 2018. Five months later, 100,000 participants have already been recruited to provide demographic, health, behavioral and genomic information, with more than 65,000 having completed the full protocol as of October 18.
The number of precision medicine projects are increasing across the globe. More than 50 such initiatives have each enrolled more than 100,000 people. Some of these projects are led by private companies like 23andMe and Google’s parent company, Alphabet; some by major hospitals and academic health systems, like Mount Sinai and its Icahn School of Medicine. Some are national initiatives, like the UK Biobank, which has partnered with a consortium of pharmaceutical and biotechnology firms. In addition, the Precision Medicine Database of the U.S. Veteran’s Administration includes over 500,000 participants.
However, two key factors distinguish the “All of Us Initiative” from some of the other ongoing efforts: NIH’s intent to make the information gleaned from the project available to researchers through a public database, and the Initiative’s focus on ensuring diversity in the populations recruited.
Traditionally, most medical research subjects have been white males. A major aim of the “All of Us” recruitment has been to ensure the inclusion of populations that are commonly underrepresented in medical research. The NIH has created a partnership with the Asian Health Coalition to reach Asian Americans, Native Hawaiians, and Pacific Islanders. In an effort to restore trust in medical research among African Americans, who historically have been included in sometimes abusive studies without their informed consent, the Initiative has been working with a network of 50,000 African American physicians to educate them and their patients about the project. Among the participants recruited to date, 75% are from groups that are often underrepresented in modern medical research, including 50% from racial and ethnic minorities.
All of these precision medicine research initiatives have ambitious goals to improve patient care as well as to discover valuable therapies matched to individual patients’ diseases. It will be interesting to see if these programs are overstating what can actually be achieved, and whether even 1 million patients will be sufficient to understand the origins and risks of common illnesses. And with so many programs underway around the world, would goals be better achieved through collaborations?