The University of Alabama at Birmingham (UAB) is continuing to enroll patients in the All of Us Research Program, a national program spearheaded by the National Institutes of Health. The goal is to enroll a million patients nationwide.
"A major aim for All of Us is to address questions in precision medicine, and by that I mean a more focused approach to an individual patient based on their background, including genetics, lifestyle and risk factors," said Cora E. Lewis, MD, chair of the Department of Epidemiology in the School of Public Health.
Lewis said cancer is the specialty that has made the most progress in precision medicine. "There has been news about genetic tests on tumors, looking at specific ways the mutated cells have gone wrong and trying to address those pathways with agents that would approach the specific pathway.
"For example, in the past when we saw something that looked like lung cancer, we would use drug X. Now, when it looks like lung cancer, we can see that a particular pathway is a problem so we address that particular pathway with drug Y.
"We're trying to get to that level of specificity for other diseases and conditions. To do that, we need a large sample size of people, and we need to follow them over a number of years for potential outcomes."
UAB launched the All of Us Southern Network, which includes Alabama, Mississippi and Louisiana, in May 2018. It is one of the largest networks in the study. All sites in the Southern Network are now set up to enroll patients, with an emphasis to reach typically under-represented populations.
"The term under-represented has a broad definition," said Mona Fouad, MD, director of the UAB Minority Health and Health Disparities Research Center. "It includes rural, elderly, minorities, LGBT, geographic locations, ethnicity, and socio-economic."
Fouad has worked for years to reach out to minorities on behalf of UAB, so she has models for reaching potential enrollees. "We are doing a lot of community engagement activities to talk about this project," she said.
There are no particular patient types or medical conditions which are targeted for the study. "This is a population base, and everyone can participate," Fouad said. "This the first in our national efforts to really understand what impacts health outcomes. Everyone can participate."
"The goal is to enroll one million people around the country, reflecting the diversity of the country," said Bruce R. Korf, MD, PhD, UAB's chief genomics officer. "They will agree to share their electronic health record (EHR) to a central database, give a blood and urine specimen, eventually have their genome sequenced, and provide body measurements such as height and weight. This project will create the largest data set of its kind in history."
Patients will receive $25 for full participation in the study.
The Southern Network has enrolled more than 8,500 patients in the first year. Ultimately their goal is to enroll 15 to 20,000 patients each year for five years. "It has taken some time in this first year to get all the sites going," Korf said. "It's a reflection of how complicated this is. The ethical oversight is exceedingly strict. When you are asking people to share their electronic health records, you have to be sure all the appropriate security and permissions are in place. It's a lengthy process."
Korf likened it to watching a jumbo jet take off. "It's a long runway, and when it finally lifts off, it looks like it's lumbering its way into the air, but then once it gets to altitude, it has enormous power and range," he said. "That's how this study has been. We are the biggest network in the entire national group, and there are a lot of moving parts. It takes time to get it assembled. Now we are finally reaching full speed."
All of the physicians stressed the high level of security the study has established. "Everything is done with state-of-the-art encryption," Korf said. "There are strict security procedures at every step of the process from the acquisition of data to its storage in the central database. Beyond that, the most sensitive data, things that make it easiest to identify a patient, are stripped away and not even sent to the central database. A person's name and date of birth do not show up in a way to make it easy to figure out who that person is."
"We need to be sure it's bullet proof," Lewis said. "Our highest duty is to protect the participants. We are promising them we will keep their information secure, so we are trying to proceed as quickly as we can under the requirement that we have the most stringent data security there is."
"This is taking place under a certificate of confidentiality. It is protected information so even the court system or the police cannot access the data. They are not able to subpoena the information for any reason. The genomic data is likewise secured," Korf said.
Patients age 19 or older, regardless of health status, are eligible to enroll in the program by visiting JoinAllofUs.org/UAB. They will have access to study information and data about themselves, with choices about how much or little they want to receive.
"We would love to have physicians refer patients to us," Fouad said. "That benefits the entire medical field. We are not treating anything or testing any drug. We are just collecting data, not interfering with their care. This is a great opportunity for patients, for the medical field, and for advancements in medicine."