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Issue link: https://clinicalomics.epubxp.com/i/898657
40 Clinical OMICs November/December 2017 www.clinicalomics.com Precision Medicine Playing Catch Up The All of Us Precision Medicine Study Looks to a New Beta Phase to Prepare for a Spring 2018 Launch By Meghaan Ferreira I n 2015, President Barack Obama declared, "I want the country that eliminated polio and mapped the human genome to lead a new era of medicine," as he launched the Precision Medicine Initiative, now rechristened as the All of Us Research Program. The program's overarching goal to accelerate the development of new, personalized strategies for preventing, diagnosing, and treating disease could revolutionize medicine. But it's the method, which entails recruiting one million Americans to share information about their genes, environment, lifestyle, and health, that might make it the most ambitious study of its kind. Starting this November, All of Us will commence an expanded beta phase to prepare for its national launch in spring 2018. Testing the logistics of the program and collecting participant feedback has kept their program busy during the initial beta phase, but the announcement of a second beta phase means delaying the main event. The planned ten-year longitudinal study, which is expected to cost $4.3 billion over its lifetime, had discussed open- ing enrollment in 2016, but decided to wait. Now, with their enrollment num- bers lagging, at a roughly only half of the projected number, speculators ask if they're ready for flight or still just taxiing down the runway. Despite the numbers, the National Institutes of Health All of Us Deputy Director, Stephanie Devaney, Ph.D., remains opti- mistic as the program sur- passes 5,000 enrollees. "We had originally hoped that we would have about 10,000 [beta testers] based on our projection for the num- ber of sites that could come on board over the spring and summer," she said. All of Us' conservative approach allowed only one or two enrollment sites onboard at a time, and, while the sites currently enrolling participants have met their numbers, Devaney said "getting all of the legal agreements into place amongst the sites" has taken lon- ger than expected. Not only does each enrollment site need to establish contracts, such as interconnection security agreements, which protect data en route, they also must undergo a rigorous approval process by an Institutional Review Board (IRB). Thirteen of the healthcare provider organization (HPO) sites partnered with All of Us have now started patient enrollment. Devaney anticipates the remaining four HPO sites, and the majority of direct volun- teer sites, will begin enrollment in the coming months—putting them back on track for the national launch. The San Diego Blood Bank is the first direct volunteer site to begin enrolling participants, and, according to CEO David Wellis, Ph.D., "It was about a year between making the announce- ment that we were awarded our grant and actually registering participants." As they navigated the already com- plicated skies of IRB-approval for the large-scale study, Wellis commented "at times it felt like we were building the plane as we were in flight,"—espe- cially amid the turbulence of adminis- trative change. The San Diego Blood Bank has a database of around one million donors, and All of Us estimates that direct volunteer sites will recruit around 350,000 participants com- bined over the next four to five years. However, it's not just about the num- bers. The blood bank's database mir- rors the diversity of the broader San Diego community. Wellis remarked, "The altruistic act of giving blood cuts across all ethnicities." The diversity represented by the San Diego Blood Bank is significant, as All of Us seeks to address the lack of patient diversity in clinical research data. This has created inequity in the "At times it felt like we were building the plane as we were in flight." —David Wellis, Ph.D., CEO, San Diego Blood Bank