Research Program To Enroll Over 1 Million Participants To Study Genes
The NIH eventually hopes to enroll over 1 million participants in the next step of what four researchers referred to in a 2003 paper as “a revolution in biological research.” In the biggest-ever bet on precision medicine, the data-gathering experiment, dubbed “All of Us,” is an important stop on the way to making personalized medicine a reality around the world.
Every day, millions of people are taking medications that will not help them. The top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them. For some drugs, such as statins — routinely used to lower cholesterol — as few as 1 in 50 may benefit. There are even drugs that are harmful to certain ethnic groups because of the bias towards white Western participants in classical clinical trials.
Recognition that physicians need to take individual variability into account is driving huge interest in ‘precision’ medicine. In January, US President Barack Obama announced a US$215-million national Precision Medicine Initiative. This includes, among other things, the establishment of a national database of the genetic and other data of one million
people in the United States.The NIH’s massive “All Of Us” project will push what’s called precision medicine, using traits that make us unique in learning to forecast health and treat disease. Partly it’s genetics. What genes do you harbor that raise your risk of, say, heart disease or Type 2 diabetes or various cancers?
Not to mention differences based on age, gender, race and ethnicity, and socioeconomics.
Layering all that information in what’s expected to be the largest database of its kind could help scientists spot patterns, combinations of factors that drive or prevent certain diseases — and eventually, researchers hope, lead to better care.
Pilot testing is under way, with more than 2,500 people who already have enrolled and given blood samples. More than 50 sites around the country — large medical centers, community health centers and other providers like the San Diego Blood Bank and, soon, select Walgreens pharmacies — are enrolling patients or customers in this invitation-only pilot phase.
Precision medicine is used most widely in cancer, as more drugs are developed that target tumors with specific molecular characteristics. Beyond cancer, one of the University of Pittsburgh’s hospitals tests every patient receiving a heart stent — looking for a genetic variant that tells if they’ll respond well to a particular blood thinner or will need an alternative.
The aim is to expand precision medicine.
If the pilot goes well, NIH plans to open the study next spring to just about any U.S. adult who’s interested, with sign-up as easy as going online. The study aims to run for at least 10 years.
The study starts simply: Volunteers get some standard health checks — weight, blood pressure and heart rate. They answer periodic questionnaires about their health, background and habits, and turn over electronic health records. They give a blood sample that, if they agree, will undergo DNA testing sometime next year.
Eventually, researchers will ask some participants to wear sensors that may go beyond today’s Fitbit-style health trackers, such as devices that measure blood pressure while people move around all day, or measure environmental exposures.
The NIH now has affiliates at health centers and health provider organizations around the country, where beta-phase enrollment is taking place in various stages.
Researchers also launched a trial “direct volunteer approach” in San Diego, in which people waiting in line at the city’s blood bank are also asked whether they would be willing to enroll in the study.
In that model, researchers assume potential participants have at least some knowledge of precision medicine and genomic sequencing — and allow those who want to enroll to simply walk up and register.
