Support Medicine Research Throught Opening up Relevant Data of the Field (US0060)

The President’s Precision Medicine Initiative (PMI) seeks to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, and ultimately help improve public health outcomes. PMI is a cross- governmental effort driven by the White House, the Department of Health and Human Services, the Department of Veterans Affairs, and the Department of Defense. Under PMI, the United States commits to building a volunteer research cohort of more than one million participants who are centrally involved in the design and implementation of the cohort, and to link genomic data, biological samples, data from mobile devices, and lifestyle data with clinical data from electronic health records. The Administration will also promote “direct- from-participant” functionality allowing patients to directly access and donate their health data for research. A priority under PMI is to ensure inclusion of low-income and underserved populations that have traditionally been underrepresented in scientific research — both improving the quality of research and ensuring that existing health disparities are not exacerbated.

For details of these commitments, see the report: https://www.opengovpartnership.org/documents/united-states-mid-term-report-2015-2017/

Commitment 8. Data-Driven Precision Medicine

Commitment Text:

Empower Americans and Improve Health with Data-Driven Precision Medicine

The President’s Precision Medicine Initiative (PMI) seeks to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, and ultimately help improve public health outcomes. PMI is a cross- governmental effort driven by the White House, the Department of Health and Human Services, the Department of Veterans Affairs, and the Department of Defense. Under PMI, the United States commits to building a volunteer research cohort of more than one million participants who are centrally involved in the design and implementation of the cohort, and to link genomic data, biological samples, data from mobile devices, and lifestyle data with clinical data from electronic health records. The Administration will also promote “direct- from-participant” functionality allowing patients to directly access and donate their health data for research. A priority under PMI is to ensure inclusion of low-income and underserved populations that have traditionally been underrepresented in scientific research — both improving the quality of research and ensuring that existing health disparities are not exacerbated.

Responsible Institutions: Department of Defense, Department of Energy (DOE), Department of Health and Human Services (HHS), Department of Veterans Affairs (VA), and the National Institute of Standards and Technology (NIST) at Commerce

Supporting institutions: Researchers, technologists, health and privacy advocates, medical professionals and care providers, veterans, and the public

Start Date: Not Specified  End Date: Not Specified

Commitment Aim

This commitment builds on President Obama’s Precision Medicine Initiative. [95] It aimed to usher in a new era of medicine characterized by individually tailored (i.e., “precision”) medical care using individual-level genomic, biological, lifestyle, and clinical data. The main activity envisioned under this commitment was constructing a volunteer research cohort of one million people to participate in a large-scale genomic study. The commitment sought substantial representation of low-income individuals and those from underserved communities. In addition, all participants were expected to have the ability to freely access and donate their own health data.

Status

Midterm: Limited

The government had made limited progress on this commitment by the midterm. The National Institutes of Health (NIH) had received $130 million in funding [96] to begin building the volunteer research cohort program. In February 2016, the NIH began awarding grants to organizations that would help support the initiative. [97] That same month, the NIH revised its goal of recruiting 79,000 volunteers by the end of 2016 [98] and the full cohort by the end of 2019. [99] By June 2016, no participants had been recruited. The program was officially designated the All of Us Research Program in October 2016. [100]

As for enabling members of the public to donate their own health data, the NIH and the Office of the National Coordinator for Health Information Technology, in February 2016, launched Sync for Science (S4S). S4S is a pilot tool that allows individuals to access and share their health information. [101] The government expected the tool become a key aspect of the All of us Research Program.

End of Term: Limited

At the end of term, the government had made limited progress on the core activity described under this commitment: the recruitment of a volunteer research cohort. On 5 June 2017, Eric Dishman, the director of the All of Us Research Program, announced that the program’s recruitment efforts had entered beta testing. [102] This effort will be in conjunction with the program’s community health partners. Recruitment will initially be limited to a single site and later expanded to 100 sites throughout the United States. The program then aimed to recruit a beta test cohort of 10,000 volunteers, with recruitment scheduled to begin in early fall 2017. [103] This time frame falls beyond the assessment period for the commitment (which ends in June 2017). The time frame also indicates that the program did not meet its earlier recruitment goal of 79,000 volunteers by the end of 2016.

Did It Open Government?

Access to Information: Did Not Change

Civic Participation: Did Not Change

The All of Us Research Program was expected to launch its beta recruitment phase in fall 2017, which lies beyond the assessment period for this report. The commitment, therefore, did not open government with respect to access to information during the time frame of the action plan.

Regarding civic participation, the commitment’s relevance to this OGP value stems from a statement made by the director of National Institutes of Health (NIH) in relation to the Precision Medicine Initiative: “Participants will be true partners, not subjects, not patients.” [104] At the close of the end-of-term reporting period, the All of Us Research Program’s advisory panel comprises individuals from the NIH’s Council of Councils. (The advisory panel is presumed to refer to the aforementioned “advisory board”; the Council of Councils serves as an advisory body to the NIH director. [105]) The panel members have professional backgrounds in science and medicine. The advisory panel’s webpage [106] makes no mention of incorporating patients as panel members. Less information is available on the program’s steering committee, which does not appear to have a webpage. However, the NIH has separately noted that the “Program[’s] Steering Committee consists of the Program Directors/Principal Investigators (PDs/PIs) from each of the major awards,” referencing those partner organizations who are program grantees. However, the NIH makes no clear reference to participation by patients or the public more broadly. Based on this information, the commitment cannot be said to have opened government with respect to civic participation.

While this commitment did not result in any changes in government openness during the span of the action plan, other precision medicine initiatives did. These took place outside of the OGP framework. For example, in June 2016, the National Cancer Institute launched the Genomic Data Commons, a repository for open genomic data for cancer research. [107] Researchers can search, download, and upload genomic data. As of early 2018, the database included more than 30,000 cases and 300,000 files. [108] The cost of analyzing a single cancer genomics dataset in 2016 exceeded $1 million. [109] However, the dean of the Biological Sciences Division at the University of Chicago acknowledged that with this new information, “the pace of discovery shifts from slow and sequential to fast and parallel. Discovery processes that today would require many years, millions of dollars, and the coordination of multiple research teams could literally be performed in days, or even hours.” [110]

Carried Forward?

At the time of writing, the government had not yet published its fourth national action plan. The government should nevertheless continue making efforts to support the All of Us Research Program. The program stands unprecedented in size and scope, and may therefore have a potentially transformative impact on healthcare in the United States. To achieve impact in the future, it is important that the government follow through on its promise to build a representative cohort of participants. It should also disclose the results of the study and engage participants in the design and implementation of the program.

There is also widespread public support for the program. This suggests a demand for precision medicine initiatives among the population at large. A blog post from 17 August 2016 on the program’s website confirms this. It noted results from a nationwide representative survey of 2,601 randomly selected individuals conducted by National Institutes of Health researchers. The survey found that 79 percent expressed support for the program after reading a brief description of it. Also, 54 percent of respondents indicated they would definitely or probably participate if invited. [111] Importantly, intended participation rates among respondents who indicated they would “definitely” participate were constant across demographic groups. This includes those from historically underserved communities, highlighting the program’s potential value to individuals from these communities.

[95] “The Precision Medicine Initiative,” The White House, 12 March 2016, https://obamawhitehouse.archives.gov/precision-medicine, consulted 3 October 2017.

[96] “About the All of Us Research Program,” All of Us Research Program, https://allofus.nih.gov/about/about-all-us-research-program, consulted 10 September 2017.

[97] “Awardees,” National Institutes of Health, All of Us Research Program, https://allofus.nih.gov/funding/awardees, consulted 2 October 2017.

[98] Francis S. Collins, “NIH Director’s Statement: Preparing to Launch the Precision Medicine Initiative Cohort Program,” All of Us Research Program, 25 February 2016, https://allofus.nih.gov/news-events-and-media/announcements/nih-directors-statement-preparing-launch-precision-medicine, consulted 10 September 2017.

[99] Ibid.

[100] “PMI Cohort Program Announces New Name: The All of Us Research Program,” All of Us Research Program, 13 October 2016, https://allofus.nih.gov/news-events-and-media/announcements/pmi-cohort-program-announces-new-name-all-us-research-program, consulted 10 September 2017; All of Us Research Program, https://allofus.nih.gov/, consulted 10 September 2017.

[101] Jon White, “NIH and ONC Launch the Sync for Science (S4S) Pilot: Enabling Individual Health Data Access and Donation,” HealthIT Buzz, 21 March 2016, https://www.healthit.gov/buzz-blog/health-innovation/nih-and-onc-launch-the-sync-for-science-pilot/.

[102] Eric Dishman, “Beta Testing Begins for NIH’s All of Us Research Program,” All of Us Research Program, 5 June 2017, https://allofus.nih.gov/news-events-and-media/announcements/beta-testing-begins-nihs-all-us-research-program, consulted 10 September 2017.

[103] Ibid.

[104] Toni Clarke, “White House to Advance Obama's Precision Medicine Initiative,” The Hospitalist, 7 July 2016, http://www.the-hospitalist.org/hospitalist/article/121572/white-house-advance-obamas-precision-medicine-initiative, consulted 28 September 2017.

[105] “Council of Councils,” National Institutes of Health Division of Program Coordination, Planning, and Strategic Initiatives, http://dpcpsi.nih.gov/council, last updated 8 May 2017, consulted 28 September 2017.

[106] “All of Us Research Program Advisory Panel,” All of Us Research Program, https://allofus.nih.gov/about/who-we-are/all-us-research-program-advisory-panel, consulted 28 September 2017.

[107] National Cancer Institute, Genomic Data Commons, https://gdc.cancer.gov/.

[108] National Cancer Institute, GDC Data Portal, https://portal.gdc.cancer.gov/.

[109] Robert L. Grossman et al., “Toward a Shared Vision for Cancer Genomic Data,” The New England Journal of Medicine (22 September 2016), http://www.nejm.org/doi/full/10.1056/NEJMp1607591#t=article.

[110] Amber Harmon, “Genomic Data Commons: Expanded Access to Large-Scale Cancer Genomic Data,” Science Node, 10 December 2014, http://bit.ly/2pVe1Rg.

[111] “Survey Shows Broad Support for National Precision Medicine Study,” All of Us Research Program, 17 August 2016, https://allofus.nih.gov/news-events-and-media/announcements/survey-shows-broad-support-national-precision-medicine-study, consulted 10 September 2017.