- The All of Us Research Program is in its expanded beta phase and is making strides in patient engagement and data capabilities in preparation for its national launch, according to program director Eric Dishman.
The program, which began its initial beta phase in May of 2017, ultimately aims to collect clinical, lifestyle, and genomic data from at least one million diverse participants over the next few years to advance the development of precision medicine.
“This is a grand experiment of trying to combine a lot of these things that may have been done in pieces in other cohort programs but trying to bring them all together at this scale does make it pretty novel and rather new,” Dishman said in a recent meeting of the All of Us advisory panel.
As of January 17, 2018, more than 18,000 participants had at least started the enrollment process. Of those participants, more than 11,500 have completed the full participant protocol.
“This is going to be over the number that we had anticipated of wanting to do during our beta phase,” Dishman said. “We had been aiming to do 10,000 to 15,000 participants at some stage of the beta enrollment process.”
The program is also working to increase the number of participant samples in their biobank.
“Right now, we’re at about 200 to 300 people per day, coming in somewhere around the country, getting their samples shipped to the biobank,” Dishman noted.
“We’re going to do a surge test in a few weeks of 600 per day, which is a capacity that will ramp [up] to around the time of launch, and then over the rest of this year and into the first part of next year we’ll ramp to about 1200 per day, [which is our] theoretical capacity.”
Dishman said that expanding participant engagement in diverse communities will require bringing on more direct volunteer and healthcare provider organization locations around the country.
“Some people think that at national launch we won’t continue to add sites, and that’s not the case,” he said. “This will be an ongoing thing as we open up more capacity in general and then do targeted capacity in parts of the country where we’ve got a lot of interest, but we don’t necessarily have all the infrastructure to carry [participants] all the way through [enrollment].”
Dishman stated that the program’s direct volunteer and provider networks have launched over 70 enrollment sites around the country, and that number is expected to grow even after the national launch.
In addition, all 18 of the program’s partners have begun awareness and engagement campaigns within the communities they serve.
“The goal is to really educate the country on precision medicine and start to build that relationship by being really clear about what the potentiality is, as well as what the downsides may be of both being part of the study and what we don’t get now in terms of precision medicine,” Dishman said.
“We want to improve the enrollment site with better design and simpler path, as it’s a pretty complex protocol and pretty complex thing to explain to people,” he added. “We want to make sure that we answer questions and have places where people can dive deep into understanding what’s going on.”
All of Us is working to capture a complete record of patients’ health by collecting data from electronic health records, patient-reported information, and mobile health data.
“We have started receiving EHR records into the database and we’re starting to clean and curate that data, as well as people’s answers to survey questions,” said Dishman.
“We’re not doing anything with mobile health yet, but it’s a goal of the program to do that. We’ve announced a partnership with Fitbit to start the pilot and learn what it’s like to be able to use that data.”
Dishman also stated that the program will introduce its research center six to twelve months after the national launch to ensure they have captured secure, quality data. “You’ve got to have enough data into the system to be useful as well as make sure all of those tools are thoroughly tested, including additional security.”
“This is going to be an ongoing journey of investments and efforts and programs that we’re going to have to do to get increasingly rich longitudinal clinical records. We’re striving to figure out the responsible ways to give both raw data as well as results back as we collect data about individuals over time,” Dishman concluded.