DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING SUMMARY OF THE
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

September 12, 2017

The 274th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, September 12, 2017, in Building 35A, the Porter Neuroscience Center Conference Center, National Institutes of Health (NIH), Bethesda, Maryland. The meeting included the Advisory Council’s Board of External Experts (BEE) Working Group members. It was open to the public from 8:03 a.m. until 8:57 a.m. Closed session began at 8:58 a.m. and adjourned at 12:59 p.m. An additional open session was held from 2:53 p.m. to 3:51 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending

Dr. Dale E. Abel 
Dr. Donna K. Arnett 
Dr. Bradford C. Berk
Dr. Nancy J. Brown 
Dr. James D. Crapo 
Dr. George Q. Daley 
Dr. Michael R. DeBaun
Dr. Serpil C. Erzurum 
Dr. Fernando D. Martinez
Dr. Pilar N. Ossorio 
Dr. Kim M. Smith-Whitley 
Dr. Sally E. Wenzel
Dr. Phyllis C. Zee 

Council Members unable to attend

Dr. Karen Glanz
Dr. Diane J. Nugent
Dr. Robert C. Robbins
Dr. Richard S. Schofield (ex officio)

Ad Hoc Member attending 

Dr. M. Luisa Iruela-Aripse 

BEE Members attending

Dr. Nancy Berliner
Dr. Eric Boerwinkle
Dr. William W. Busse
Dr. Barry S. Coller
Dr. Allen W. Cowley, Jr.
Dr. Ronald G. Crystal
Dr. Karina W. Davidson
Dr. Christopher B. Granger
Dr. Judith S. Hochman
Dr. Isaac S. Kohane
Dr. Deborah Nickerson
Dr. Paul M. Ridker

NHLBI employees attending 

A number of NHLBI staff members were in attendance.

Other NIH employees attending

Dr. Gene Carsteae, CSR
Dr. Gniesha Dinwiddie, CSR

Public attending

Dr. Lauren Brood, American Association of Immunologists
Mr. Jeffrey Cooper, CooperSoft
Dr. Mridul Datta, Purdue University
Mr. Patrick Hein, Purdue University
Dr. Andrea Kasinski, Purdue University
Dr. Stephen Lindemann, Purdue University
Ms. Haley Payne, Health and Medicine Council of Washington

OPEN SESSION

I. CALL TO ORDER AND OPENING REMARKS

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members and other attendees and called the 274th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director, Division of Extramural Research Activities (DERA), NHLBI, made the required announcements for the Council meeting, including: a notice of the meeting was published in the Federal Register, Council members may not engage in lobbying activities while attending Council meetings or sponsored events, and the open session was being recorded.

III. NIH CLINICAL TRIALS UPDATE

Dr. Michael Lauer, Deputy Director for Extramural Research, NIH presented an overview of the new NIH clinical trials policies recently released by NIH.

Dr. Lauer reviewed literature from major clinical journals suggesting that clinical trial results are often not made publicly available because the results are not reported on ClinicalTrials.gov and not published in a journal. Lack of public reporting, Dr. Lauer observed, can ultimately hurt
patients, society, and science.

To address concerns, the NIH announced in September 2016 a new NIH policy on the dissemination of NIH-funded clinical trial information. The new NIH policy broadened the ClinicalTrials.gov registration and reporting requirements to any NIH-funded trial (not just those subject to FDA oversight).

Dr. Lauer then discussed other elements of a suite of clinical trial reforms that NIH is undertaking related to key control points in the lifespan of a clinical trial. A key reform initiative is a new application form (FORMS-E) that identifies and collects important data on research with
human subjects, including clinical trials. This will allow for the identification and characterization of NIH-funded clinical trials in a manner not previously possible. Dr. Lauer shared the location on the OER Web site where more information may be found.

Council members questioned why some investigators are not publishing results. Members also asked whether an investigator’s publication track record could factor into the review of future grant applications. Other questions and comments covered how to better communicate trial results and science in general with the lay public, public confusion over the significance of a trial registration in ClinicalTrials.gov, the costs of institutional compliance with this and other grant requirements, and educating the research community about which research activities are considered clinical trials.

CLOSED PORTION 

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosures under Sections 552b{c){4) and 552b{c){6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2).

IV. REVIEW OF GRANTS AND STRATEGIC VISION IMPLEMENTATION PLANS

The NHLBI Division and Center Directors presented brief overviews of how their programs are implementing the NHLBI Strategic Vision. The discussion that followed included thoughts about future funding opportunities and implementation tracking.

OPEN SESSION

V. REPORTING FROM WORKING GROUP DISCUSSIONS

Dr. Nakela Cook, Chief of Staff, Immediate Office of the Director, NHLBI, facilitated this portion of the meeting. The Chair of each Working Group presented their charge, suggestions, conclusions, and additional questions. Each presentation was followed by a discussion to refine
and identify the ideas.

VI. CONCLUDING REMARKS

Dr. Gibbons thanked the members for their contributions and adjourned the meeting.

ADJOURNMENT 
The meeting was adjourned at 3:51 p.m.