‘Poised at an Exciting Moment’
New CC Authority, Grant Disparity, Zika Top ACD Agenda
Photo: Ernie Branson
Crucial topics at home and abroad headlined the most recent meeting of the advisory committee to the NIH director (ACD).
At NIH home base, the Clinical Center’s leadership began to undergo some of its first significant restructuring since opening in 1953, in response to recommendations by the ACD-appointed Red Team [see sidebar 1].
In the extramural community, persistent disparities in funding outcomes for African-American grant applicants will be studied further following new analysis by NIH’s Office of Scientific Workforce Diversity [see sidebar 2].
Globally, the Zika outbreak has spread to Puerto Rico with no signs of slowing. Newly confirmed facts about the virus’s impact on fetuses, newborns and pregnant women require immediate and comprehensive research, according to updates by leaders of NIAID and NICHD [see sidebar 3].
These issues, reports on the Cancer Moonshot and Big Data to Knowledge and more packed the 1½-day ACD agenda June 9-10.
Hopeful Signs on the Funding Front
As is customary, NIH director Dr. Francis Collins began the meeting with a broad view of current events and what’s happened since the group last gathered in December. He welcomed new ACD members Dr. Geoffrey Ginsburg of Duke University and Dr. Linda Griffith of MIT. Collins also talked about recent NIH senior staff appointments and searches under way.
Photo: Ernie Branson
Representatives from NIH legislative and budget offices gave updates and forecasts as well. Attendees were encouraged to hear that another $2 billion increase in the NIH appropriation has been proposed—for the second year in a row—by the Senate for fiscal year 2017. Collins praised success of bipartisan efforts on NIH’s behalf by Sen. Roy Blunt (R-MO) and Sen. Patty Murray (D-WA). The House of Representatives version was expected by the next week. A $1.9 billion emergency supplemental request for Zika is still pending.
Collins also summarized NIH’s “shared efforts in global health research” with the Bill and Melinda Gates Foundation. Bill Gates visited NIH in April at the annual day-long meeting to discuss the joint enterprise. Among topics covered were the human papillomavirus vaccine efficacy trial, collaboration on HIV vaccines, cookstoves and environmental toxin reduction and vector-based interventions for malaria containment.
“If you look at the sources of funds, when you add NIH and the Gates Foundation together you have more than 50 percent of the total world investment in global health research,” Collins noted.
PMI Proceeds Apace
Acknowledging the unprecedented speed with which the Precision Medicine Initiative Cohort Program is moving toward its first ambitious goals, Collins reiterated the program’s core values: Cohort “participants are partners” not patients; the group “needs to reflect the rich diversity of America”; data sharing “has to be swift both to the researchers and to the participants, according to what they wish to know about themselves”; and privacy and security are being “built into every component and taken with the utmost seriousness.”
Photo: Ernie Branson
Hearing the guiding principles re-emphasized, ACD member Dr. Russ Altman enthused, “That’s incredibly exciting. It’s like the Athenian model of democracy, where there are no representatives,” we’re all at the table together.
“This notion of having the participants as partners means that when you’re thinking about what the science is that you’re going to do, that it has to be both kick-ass science and it has to build the relationship with the participants—and we’re sort of more used to doing the kick-ass science,” explained NIH deputy director for science, outreach and policy Dr. Kathy Hudson. “These two things are going to have to go hand in hand from the beginning, which in some cases means that the really satisfying science might come a little bit later, in order to make sure we’re building the relationship, figuring out what people’s preferences are, making sure that we don’t do anything that threatens the trust that we so desperately hope to build.”
Photo: Ernie Branson
The PMI cohort’s first big component—the biobank—was launched, with $142 million over 5 years awarded to the Mayo Clinic to collect and store biospecimens. A PMI advisory panel and a central institutional review board with expertise in mHealth, bioinformatics, health disparities, epidemiology, genomics and other areas have also been established.
“We are trying to make PMI not just a great research project but also a motivator to fix a problem across the country in terms of electronic health records that are not as usable as people wish they were,” Collins said.
By July all the pieces will be decided; the goal, by year’s end, is to have 79,000 individuals enrolled.
“We are poised at an exciting moment,” he said.
Video of ACD proceedings is online at https://videocast.nih.gov/summary.asp?Live=19275&bhcp=1.
Zika Virus Threat Grows
The Zika outbreak continues to spread—and its effects worsen—since the virus re-emerged last year in Latin America and the Caribbean, according to NIAID director Dr. Anthony Fauci, who teamed with NICHD acting director Dr. Catherine Spong to update day 2 of ACD on NIH’s efforts to address the outbreak.
As of June, 48 countries/territories—39 in the Americas/Caribbean—have active Zika virus transmission. The virus itself is considered relatively mild and most infected individuals recover from it within days, Fauci explained. However, devastating Zika-associated birth defects, a potential link to Guillain-Barré syndrome, Zika’s capability of being transmitted sexually and other as yet unknown health effects due to the infectious disease have escalated it as a top global research priority and health threat.
“The impact on pregnancy goes far beyond what we’re seeing with microcephaly,” Spong said. “Many gaps exist about what to expect in pregnancy. We need more data.”
Several vaccine development trials are in various stages of being launched by NIAID with collaborating institutions. In addition, NIAID, NICHD and NIEHS have partnered on a Zika in Infants and Pregnancy (ZIP) trial of up to 10,000 participants to identify and document the virus’s effects on pregnant women and their fetuses and infants.
Zika update slides are online at http://acd.od.nih.gov/presentations/062016_Fauci.pdf and http://acd.od.nih.gov/presentations/062016_Spong.pdf.
Drilling Down on Grant Disparity
Photo: Credit Ernie Branson
Diversity in the scientific workforce became a concern several years ago and rose on the ACD’s agenda after release in 2011 of the NIH-commissioned Ginther study, which found that African-American/black (AA/B) applicants were less likely than whites to be awarded R01 grants from NIH during fiscal years 2000 to 2006.
An ACD-assigned working group on AA/B funding disparities followed up on Ginther, analyzing data from fiscal years 2010 to 2015.
AA/B submit fewer applications, fewer applications per AA/B applicant are submitted and fewer of their applications get discussed, AA/B applications are scored lower and fewer resubmissions come from that community. Cumulatively, the odds of an AA/B scientist being funded are 35 percent less than for a white scientist.
Summarizing key findings by a core team from that group, NIH chief officer for scientific workforce diversity Dr. Hannah Valantine said, “There is a disparity in every stage of the application from submissions to funding…This work needs to continue to be done and NIH needs to continue a vigilant eye on the issue.”
Photo: Ernie Branson
Valantine’s working group recommended several interventions to narrow the gap, including targeted mentoring/coaching on submissions. Also, the group initiated with the Center for Scientific Review an anonymized application study—a randomized controlled trial—to determine potential bias in peer review.
Collins said NIH has funded many programs over many decades to recruit more underrepresented minorities into science, and that success of past efforts has been difficult to gauge because “they were often not conducted in a rigorous way where you can tell what happened.
“We’re not going to do it that way any more,” he stressed. “We’re determined…We will expand the things that are working and we will kill the ones that are not.”
Valantine’s ACD slides are online at https://acd.od.nih.gov/documents/presentations/06092016Valantine.pdf.
Recommendations by ‘Red Team’ Set in Motion
Photo: Ernie Branson
The Red Team, a working group assembled by the ACD to evaluate the hospital following a problem last year in the CC pharmaceutical development section, reported findings at a special ACD meeting in April.
“Our current structure—the way that we currently attempt to manage the Clinical Center—makes it very difficult to achieve our end result,” said NIH principal deputy director Dr. Lawrence Tabak, giving context for the first major realignment of CC governance since the largest research hospital in the world opened.
Outlining three guiding themes—all with the overarching principle to “fortify a culture and practice of safety”—Tabak gave an update on progress NIH has made on the report’s recommendations:
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A central Office of Research Support and Compliance was formed to set policy and standards and assure quality; Dr. Kathryn Zoon was appointed as its interim director.
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A CEO position was established with authority over all NIH staff using the hospital; a search committee to fill the post will be co-chaired by NIAID director Dr. Anthony Fauci and NIAMS director Dr. Stephen Katz.
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A clinical practice committee composed of senior clinical and lab experts is forming, to provide real-time input to leadership on patient care and safety.
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A new external hospital board will hold its first meeting in July.
“Science and safety must go hand in hand,” Tabak emphasized. “There can’t ever be tradeoffs between innovation and safety and compliance. Our collective goal will be to exceed—not just meet—all safety and compliance standards and become a leader in the discipline of safety science.”
See the Red Team implementation slides at https://acd.od.nih.gov/documents/reports/06092016report-RedTeam.pdf.