precision medicine

NIH’s All of Us Research Program Issues Funding Opportunity

The National Institutes of Health’s (NIH) All of Us Research Program (formerly the Precision Medicine Initiative Cohort Program) within NIH Office of the Director has issued a new funding opportunity for organizations interested in helping engage volunteers. The funding opportunity is open to national and regional organizations, as well as local community groups. The program is designed to support activities to promote enrollment and retention in the All of Us Research Program across diverse communities. All of Us, unlike the majority of NIH-supported research, is not focused on a particular disease or population. The program is intended to “serve as a…

Precision Medicine Initiative Cohort Program Renamed “All of Us” Research Program

On October 12, the National Institutes of Health (NIH) announced that the Precision Medicine Initiative (PMI) Cohort Program has been renamed the All of Us Research Program. The name change, according to the announcement, reflects the study’s core values, which include “participation is open to all; participants reflect the rich diversity of the U.S.; participants are partners; participants have access to their information; data will be accessed broadly for research purposes; security and privacy will be of highest priority; and the program will be a catalyst for positive change in research.” The program’s name change also incorporates the feedback NIH…

NIH Appears Before Senate Appropriations Subcommittee

On April 7, National Institutes of Health (NIH) Director Francis Collins appeared before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education (Labor-HHS), accompanied by five of the NIH’s 27 institute and center directors and/or acting directors. Attending were: Richard Hodes, National Institute on Aging (NIA); Doug Lowy, National Cancer Institute (NCI); Nora Volkow, National Institute on Drug Abuse (NIDA); Walter Koroshetz, National Institute of Neurological Disorders and Stroke (NINDS); and Christopher Austin, National Center for Advancing Translational Sciences (NCATS).

NIH Director Fills Vacancies for PMI Cohort and ECHO Programs

National Institute of Health (NIH) Director Francis Collins recently announced the appointments of Eric Dishman as the Director of the Precision Medicine Initiative (PMI) Cohort Program and Matthew Gillman as the Program Director of the NIH Environmental Influences on Child Health Outcomes (ECHO).

NIH Strategic Plan, PMI Cohort, HIV/AIDS, and Big Data Discussed at NIH Advisory Committee Meeting

The December 10-11 meeting of the National Institutes of Health (NIH) Advisory Committee to the Director (ACD) included an update on the progress of several high-profile initiatives NIH is developing, including the Congressionally-mandated NIH-Wide Strategic Plan, the President’s proposed Precision Medicine Cohort Program, assessment of the NIH HIV/AIDS Research Priorities, and the NIH Big Data to Knowledge (BD2k) program.

NIH Issues Funding Opportunity to Support the PMI Cohort Program Direct Volunteer Pilot Studies

The National Institutes of Health (NIH) is seeking proposals for pilot studies and “the needed information technology support for the development of the Direct Volunteer component of the Precision Medicine Initiative (PMI) Cohort Program.” The agency plans to build a “national research cohort of one million or more volunteers who are engaged as partners in a longitudinal, long-term effort to identify the molecular, environmental and behavioral factors that contribute to diverse diseases, to facilitate the development and testing of novel therapies and prevention approaches, and to pioneer mHealth [mobile health] strategies for improving the efficacy of health care.” To that…

NIH Releases Precision Medicine Initiative Framework for Cohort of One Million

On September 17, the National Institutes of Health (NIH) Advisory Committee to the Director (ACD) presented its recommended design framework for building a national research participant group, or “cohort,” of one million or more Americans, that would be part of the President’s proposed Precision Medicine Initiative (PMI) (see Update, April 21, 2015 and June 15,2015). In a statement accepting the ACD’s recommendations, NIH Director Francis Collins pointed to the need to remain nimble and adaptable as the Initiative progresses. The agency intends to move quickly to build the necessary infrastructure so that participants can begin enrolling in the cohort in…

NIH Seeks Feedback on Using mHealth for the Precision Medicine Cohort

The National Institutes of Health (NIH) is seeking feedback from the scientific community regarding using mobile Health (mHealth) technologies for the Precision Medicine Cohort.  The agency points out that the collection of health and lifestyle data on “participant volunteers” have generally come from medical records and extensive phone or paper surveys. For the Precision Medicine Initiative (PMI), the agency is considering using smart phone and wireless technologies to collect some of this information (See Update, June 15, 2015).  The use of these devices, however, generates a number of considerations for which NIH is seeking feedback: Willingness of participants to carry…

Members of Congress Address NIH Precision Medicine Working Group Workshop on Digital Health Data and Research Cohort Design

Senator Lamar Alexander (R-TN) and Representative Marsha Blackburn (R-TN) addressed a special session of the National Institutes of Health (NIH) Advisory Council to the Director (ACD) Precision Medicine Initiative Working Group at the Public Workshop, Digital Health Data and Research Cohort Design, on the campus of Vanderbilt University on May 28-29. The workshop is part of series by the ACD Working Group and builds on the April 28-29 workshop held on the NIH campus that focused on the development and implementation of a large national cohort, as well as identification of the unique scientific questions and opportunities of using such…

NIH Requests Comment on Precision Medicine Cohort, Strategies to Address Community Engagement and Health Disparities

The National Institutes of Health (NIH) is seeking feedback (NOT-OD-15-107) to help it in creating a national research cohort of one million or more Americans as part of the President’s proposed Precision Medicine Initiative (PMI) (see Update, May 19, 2015).  The agency is specifically interested in feedback relating to the development and implementation of effective community engagement strategies for the cohort, and the ability to conduct transformative research to address health disparities.  The aim is to assemble a “cohort reflective of the rich diversity of the U.S. population.”

PCAST Hears Interim Report on Precision Medicine Initiative

On May 15, the President’s Council of Advisors on Science and Technology (PCAST) received an interim report on the President’s proposed Precision Medicine Initiative (PMI). Opening the meeting, PCAST co-chair and director of the White House Office of Science and Technology Policy (OSTP) John Holdren discussed the ongoing budget process and the challenges associated with the FY 2016 budget. Despite these challenges, Holdren noted, there are a number of exciting initiatives in progress, including the Precision Medicine Initiative.

NIH Appears Before Senate Appropriations Subcommittee

On April 30, National Institutes of Health (NIH) director Francis Collins made his annual appearance before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) to discuss the President’s proposed FY 2016 budget request for the agency. The NIH director was accompanied by several institute directors: Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID), Douglas Lowy, National Cancer Institute (NCI), Gary Gibbons, National Heart, Lung, and Blood Institute (NHLBI), Jon Lorsch, National Institute of General Medical Sciences (NIGMS), and Tom Insel, National Institute of Mental Health (NIMH). Subcommittee Chairman Roy Blunt (R-MO)…

NIH: Input Sought on Precision Medicine Cohort

The National Institutes of Health (NIH) is seeking feedback from the scientific community via a Request for Information (RFI): NIH Precision Medicine Cohort (NOT-OD-15-096) to guide it in creating a longitudinal cohort of one million or more Americans who have volunteered to participate in research as part of the President’s proposed Precision Medicine Initiative (PMI) (see Update, April 21, 2015). Specifically, the agency is seeking information on characteristics, purpose, or other overall aspects in the development and implementation of a large U.S. precision medicine cohort. As participants in PMI, individuals will be asked to give consent for extensive characterization of…

NIH Appoints Working Group for Precision Medicine Initiative

In March, National Institutes of Health (NIH) director Francis Collins appointed a team of individuals to serve on the Advisory Committee to the NIH Director (ACD) Working Group on the Precision Medicine Initiative (PMI). The Working Group is expected to host public meetings to seek public input into the development of President Obama’s proposed Precision Medicine Initiative. This group will help the NIH define “what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design, and what success would look like five and ten…

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