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-Wide Strategic Plan

NIH Principal Deputy Director Lawrence Tabak discussed the agency’s progress in developing the NIH-Wide Strategic Plan. Tabak reiterated that the plan is not designed to address the priorities of the individual NIH institutes, centers, and offices, which have their own strategic plans (see Update, July 14, 2015 and July 27, 2015). The agency-wide plan also would not “describe all the many important things that NIH does and will do in the future.” Tabak summarized the plan’s three objectives and announced the addition of a fourth objective:

1. Advance opportunities in biomedical research;
2. Set priorities (e.g., the recently-released NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding);
3. Enhance NIH’s stewardship, which includes addressing NIH’s workforce diversity and evaluating which programs work and applying that knowledge across the agency; and
4. Managing for results.

Tabak explained that the newly added fourth objective includes activities such as the continued development of the “Science of Science,” enhancement of the agency’s decision making, evaluation of the “steps to enhance rigor and reproducibility,” and the reduction of administrative burden.

According to Tabak, the NIH-wide strategic plan will also include “bold predictions” for 2020. For example:

• NIH will be known as the model agency for applying the scientific method to itself – for learning, in a rigorous way, how best to fund biomedical research.
• NIH-supported research will develop culturally precise behavioral interventions to promote health and prevent illness in populations that experience health disparities.
• Application of mobile health (mHealth) technologies will provide rigorous evidence for their use in enhancing health promotion and disease prevention.

The plan is scheduled to be transmitted to Congress by December 16 and will be posted on the NIH website.

Precision Medicine Cohort

Kathy L. Hudson, NIH Deputy Director for Science, Outreach, and Policy, and Josephine P. Briggs, Precision Medicine Initiative (PMI) Working Group co-chair and National Center for Complementary and Integrative Health (NCCIH) director, updated the ACD on the Precision Medicine Initiative (PMI) cohort program (see Update, September 22, 2015). Hudson reminded the group that Precision Medicine is more than the Initiative and consists of a number of other components, such as initiatives led by the Food and Drug Administration, the National Cancer Institute, and the Office of the National Coordinator for Health Information Technology, among others. Hudson also outlined a number of scientific opportunities afforded by PMI, including understanding and addressing the causes of health disparities, using mHealth technologies to “correlate activity, physiological measures and environmental exposures with health outcomes,” to empowering the study’s participants to improve their own health by providing data and information. The mHealth data collected would include such data as social connections, location, and movement; data that would be passively collected via smartphones; and wearable sensor data (amount of activity, hours and quality of sleep, and time sedentary).

Briggs further summarized the status of cohort-related activities. For example, a national search for a PMI Cohort director was launched, with the announcement closing on December 24, 2015; an advisory panel has been formed; and two transaction award announcements and four funding announcements for cooperative agreements have been released, including a funding opportunity announcement for the creation of a coordinating center to provide scientific and administrative leadership, direct volunteer operations, and oversee healthcare provider organization-related operations via an administrative core (see Update, December 1, 2015). She also reported that the center would administer a data core that would be responsible for general functions such as developing and maintaining all shared scientific and management data and managing all facets of data security and participant privacy protection.

NIH HIV/AIDS Research Priorities

As previously reported the NIH released in August new HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (see Update, September 4, 2015). NIH Office of AIDS Research (OAR) Acting Director Robert Eisinger provided the results of the fiscal year (FY) 2014 AIDS portfolio review to assess the extent to which current the AIDS research program is aligned with the new overarching HIV/AIDS research priorities charged to him by NIH director Francis Collins.

Eisinger explained that all grants and contracts supported with FY 2014 AIDS dollars that were eligible to recompete in FY 2015 were included in the evaluation. For determining NIH-supported AIDS funding, the assessment’s methodology required that each “project be assigned a rating of high, medium, or low priority.” Accordingly, each project was reviewed and rated by three individuals from a pool of experts consisting of the OAR senior scientific staff and a small panel of institutes and centers extramural and intramural scientific staff. Eisinger explained that a final rating for each project was determined by a majority rating with the final determination made by Eisinger based “on available data.” The institutes and centers will be provided a final list of low priority projects.

Eisinger reiterated that projects scored as low priority will no longer be supported with AIDS dollars when they recompete in FY 2016. Accordingly, the funds associated with those projects will go into a “common high AIDS relevance pool to support overarching HIV/AIDS priority projects.” Of the $2.98 billion supporting 5,243 extramural grants, 435 intramural projects, and 68 contracts, nearly $435.65 million of this sum were eligible to recompete in FY 2016, including 1,207 extramural projects ($407.4 million), 56 intramural projects ($21.4 million) and 11 contracts ($6.0 million).

Eisinger reported that of the 1,207 extramural research projects, 242 projects or 20 percent ($65.2 million), 26 intramural research projects or 47 percent ($6.6 million), and one contract worth $1.3 million were rated as low priority. These “low priority” projects, Eisinger explained, included studies on “basic virology and immunology, genomics, infectious pathogens outside of the context of HIV, and training projects with no indication of an AIDS component.”

Eisinger also reported the findings from OAR’s pro-rating pilot feasibility study which found that the results “suggested that the draft guidelines alone are not sufficient for determining an appropriate pro-ration level for individual projects.” Further, the guidelines need adjusting with additional input from and among institutes and centers and the OAR. He concluded with several recommendations, including:

• OAR should conduct a similar annual portfolio review the next 3 or 4 years “to further focus” the NIH HIV/AIDS research program “to be aligned with the new overarching priorities;”
• Consideration should be given to revisiting the priorities in FY 2017 and ensuing years “to reflect emerging scientific opportunities, changing dynamics of the epidemic, and most recent scientific findings and/or advances;”
• Clear communication of these research priorities and portfolio review processes should be made to the scientific community, research advocates, and other stakeholders;” and
• OAR should further refine trans-NIH pro-rating guidelines in close collaboration with the institutes and centers for FY 2016.

NIH Big Data to Knowledge (BD2K)

Finally, NIH Associate Director for Data Science Philip Bourne provided an update on the NIH Big Data to Knowledge (BD2k) program (see Update, October 1, 2015). His comments were consistent with those given at the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils along with a recently penned blog post by Bourne and Vivien Bonazzi, ADDS Senior Advisor for Data Science Technologies and Innovation, explaining the NIH Commons,. They defined it as “a shared virtual space where scientists can work with the digital objects of biomedical research” (see Update, November 3, 2015).