All of Us program wants to change the face of medicine

Pitt received a $46 million award in 2016 from National Institutes of Health to build the partnerships and infrastructure needed to carry out the All of Us initiative, which seeks to gather health information from 1 million people nationwide to create a database to study different diseases and other maladies, and in the process change the face of medicine.

In Pennsylvania, Pitt is responsible for recruiting 120,000 participants and by early this week had reached 11,610. Nationally, there are more than a dozen other organizations now gathering participants and more than 80,000 people have enrolled nationwide. There are between 40 and 50 people working on the project at Pitt.

Reis, who is associate vice chancellor for clinical research at the Pitt Schools of Health Sciences and director of the Clinical and Translational Science Institute, said his group at the institute was uniquely situated to participate in All of Us.

The institute “supports translational research, meaning how to get research from the bench to the bedside, to the patient, to practice, to the community, to health policy,” Reis said.

Their work includes a community partners core, an informatics core, a regulatory core, statistical support and more.

“When this project came around, we looked at it and we essentially had all of the pieces of the puzzle,” Reis said. “And this project aligns with one of the scientific missions of the Health Sciences here — precision medicine. Scientifically, we were interested in this field, and logistically, we had all the pieces, so we put this grant in and we actually got the best score in the country. We were the first institution to enroll patients in the country. So patient No. 1 was enrolled in Pittsburgh. The first several hundred actually were enrolled in Pittsburgh, at Pitt.”

Gathering information

Participants in All of Us, who need to be 18 or older, will be asked to fill out a consent form and health surveys, which can be done online or at one of the enrollment centers in about 35 to 45 minutes. The survey will include lifestyle questions about diet, sleep habits, occupational exposure and more, Reis said. Participants also will agree to provide access to their electronic health records, which will be stored in a secure database.

The study requires just one visit to an enrollment center for staff to take physical measurements (blood pressure, height, weight) and biospecimens (blood and urine). After the visit, participants will receive $25 in compensation and may be contacted to answer additional surveys from time to time. You can choose to answer the surveys or not. You also will receive updates on the study.

The information will be stored in a secure central database created by Vanderbilt University Medical Center, Verily Life Sciences (a Google company) and the Broad Institute in Cambridge, Mass. Volunteers will have access to their study results, along with summarized data from across the program.

Chancellor Patrick Gallagher became part of the study early on.

“I was proud to participate — and to support Steve and his team as they work to expand our understanding of health and the field of precision medicine,” Gallagher said. “The entire experience was quick and easy with the added benefit of contributing to an important health initiative that’s anchored right here in Pittsburgh.”

Reis and his team started out focusing on Western Pennsylvania but are now moving eastward toward Philadelphia. They’ve teamed with Temple University in Philly and with UPMC in Altoona and are in discussions with UPMC Susquehanna.

“We thought it was important to really incorporate the whole state of Pennsylvania,” Reis said. “What I tell people is that these results are going to change the future of medicine and are going to change how we’re all being treated. And if we don’t have representatives from Pennsylvania, then the results may not be relevant, as our exposures, our geography, our health may be very different than other parts of the country.”

All of Us also wants to make sure to include a cross-section of people from different races, ethnicities, ages, economic levels, rural vs. urban dwellers, genders and more. It has partnered with local organizations, like the Urban League of Pittsburgh, to reach out to their communities.

Reis said NIH has identified groups that are underrepresented in biomedical research, and the goal is to have 49 percent of the people enrolled in All of Us to come from these groups. For instance, he said All of Us at Pitt has enrolled the highest proportion of people over 65, “and that’s really important, because that’s been identified as a group that’s been traditionally underrepresented in biomedical research.”

If they identify an area or group that’s underrepresented, they can target that area with a marketing campaign to encourage participation.

Translating the data

How, though, will all this information change medicine?

Once all the data is gathered, it can be used by researchers — from high-school and college students to high-tech labs, each with varying degrees of access — to study and compare how different people respond to different medications, diseases, etc.

Reis cited an example related to blood pressure medicine. Most people with high blood pressure are given the same or similar medicine, Reis said, “but it turns out, we all metabolize medicine slightly differently. And there are sets of genes that influence how we metabolize medications.”

“The FDA says we as providers should be prescribing based on genetic information. But if you ask the average provider, almost all providers will say they don’t do that, because they don’t have the genetic information available on their patients, or they don’t have the knowledge of how to apply their genetic information.

“So as part of this study, just one small part, participants will be tested for what we call pharmacogenomics for these thousands of genetic variants that influence how we metabolize medications. And with those results, providers can make more informed decisions based on their genes.”

In the future, when genetic testing will probably be more widely available, doctors can provide precision prescribing.

“You can say the same thing for preventing disease,” Reis said. “This study will develop biomarkers, essentially better ways to identify risks for diseases, which then will allow targeting a preventive therapy.”

So that you can identify genetic profiles that are more prone to a certain disease and then target the people with that profile with preventative measures.

Reis hopes to get Pitt’s faculty and staff interested in participating in All of Us and to have them spread the word.

“I’m hoping that they’ll see value at different levels,” Reis said. “I’m hoping they’ll see value altruistically — how we’re going to change the future of medicine — that will help us and will help future generations.

“I’m hoping they’ll get behind it because they want to advance science, which as faculty will give their students opportunities to tap into this database. And it doesn’t have to be just Health Sciences students. Computer science, for instance, they can use this database to develop new algorithms and machine learning. So, I think academically there are reasons why we should be part of it. And to be part of it, we need people enrolled.”

Source: University of Pittsburgh