ADDENDUM TO THE REPORT OF THE NHLBI
COUNCIL'S WORKING GROUP ON EPIDEMIOLOGY OF OCTOBER 1998
(Presented by Dr. Abboud at the NHLBI Council on
February 4, 1999)
This is an Addendum to the Report of the
NHLBI Council's Working Group on Epidemiology of October 1998. It was prepared
as a follow-up to the NHLBl Response to the Report and the Institute's
implementation plans dated January 8, 1999.
Addendum is intended to:
- Endorse the Institute's Response to the Working
Group's (WORKING GROUP) Report and support the momentum that has been
- Provide suggestions from the WORKING GROUP for
consideration by the Institute as it proceeds with implementation of the
changes planned in the response of January 8, 1999.
Suggestions and Comments on the
The Working Group recognizes that several statements
in the letter from Dr. Lenfant to Dr. Abboud, dated January 8, 1999, reflect
the sincere desire of the Institute to address the concerns of the
Epidemiology-Prevention community. These include statements such as:
"---many of the recommendations (of the WORKING
GROUP), programmatic and strategic, will help us to focus on how to do a better
job to serve the community that depends on the support of the Institute."; and
"Personally, I feel very strongly that the Institute
must be open to all recommendations, and I hope we have been."; and
"There is much for us to do to implement our response
and will take time to put everything in place;" and finally,
"It is clear that population-based studies have some
unique features relative to the duration and the cost---"
||Explore Novel and Unique Areas in
|Use data from longitudinal cohort
studies as a resource for R01 inter-institute initiatives, cross- institute
collaboration. Genetic risks, subclinical. Enhanced training.
The Working Group is pleased that the Institute is
enthusiastically supportive of this goal and will send a strong message to the
scientific community encouraging studies that are responsive to it. It is also
indicated that the Institute will sponsor task forces that will make
recommendations for further studies.
The Working Group suggests that Task Forces need to be
supplemented with a process of ongoing scientific advisory input and review for
long-range planning, since Task Forces are targeted and short lived. Perhaps
the proposed Board of External Advisors will provide that opportunity.
||Provide More Leadership in the
Development and Fostering of Prevention Science in the Area of Cardiovascular
The Working Group is pleased that the Institute will
intensify its work with other organizations to fortify activities in this area
and insure meaningful translation. Research prevention strategies will be
stimulated with program announcements and the director of DECA will take the
lead in this assessment in conjunction with other division directors. The
proposed continued input from the scientific leadership in the community is
laudable. Proposed interactions among programs and division directors will
allow much more sharing of valuable resources.
||Foster Maximum Application of
Epidemiologic and Biostatistical
Methods and Enabling Strategies to the
Spectrum of Basic and Translational Research in Heart, Lung, and Blood
We are pleased that the Institute shares the
appreciation of epidemiology as a key enabling science that has the capability
of building bridges between other research approaches. The plan of the
Institute will increase the capability to meet the emerging needs in
epidemiologic and statistical methods. It is suggested that the support of
coordinating centers might be increased in order to permit the available
resources to be accessible to investigators from various divisions to explore
new ideas and to facilitate close NIH collaborations.
||Establish a Scientific Advisory
Subcommittee of the NHLBI Council to Work with Staff on Recommending Priorities
We are pleased with the Institute's support of the
concept of a scientific advisory structure and the regret that was expressed
about being forced to disband the structure that had been in place for many
years. The Institute refers to the plan for development of a new Council
subcommittee type entity that will be structured to provide scientific and
programmatic advice on all of the extramural programs of the Institute. It will
be called the Board of Extramural Advisors and will make its recommendations to
Council. The Working Group believes this is a laudable and important
Institute-wide initiative. The Group believes also that it is necessary to have
a critical mass of leading cardiovascular epidemiology-prevention scientific
expertise to provide the necessary ongoing recommendations, priorities, and
initiatives. The Institute may wish to consider subcommittees to address more
specific missions of each division of the Institute as related to epidemiology
|| Importance of Epidemiology/Prevention
and Resource Value of Cohort Studies.
The Working Group is pleased with by the Institute
recognition that longitudinal population- based cohort studies remain an
essential component of its overall research program and constitute a unique
resource that has important potential for uncovering new disease risk factors
as well as health determinants. The Working Group is also pleased that the
Institute plans, in consultation with the Council, to develop processes to
conduct independent programmatic reviews of ongoing studies and will issue a
vigorous scientific merit review before deciding on extending funding beyond
the initial commitment period.
The intent of the Institute to use all mechanisms
available to work with investigators in support of insuring wide availability
of the data derived from longitudinal cohort studies is very positive.
||The Need for More Clearly Defined
Opportunities in Translational Research.
The Working Group is delighted with the commitment of
the Institute to fostering translation of research data to clinical and
community settings and encouraging interaction between various divisions, for
example, OPEC and DECA, and other Institute divisions as well as other
government agencies. The WORKING GROUP supports the plan of the Institute to
continue to work with voluntary organizations on issues of mutual interest.
The Working Group proposes that the use of the
resources and perspectives of the clinical application prevention programs can
be very useful for other research groups in other divisions.
With respect to translational research the Working
Group wishes also to share the recent experience of the American Heart
Association with a recent RFA for which it received 410 letters of intent and
260 research proposals for health services research, clinical epidemiology,
demonstration and education, etc. It appears that there may be a large
community which does not feel the translational research in cardiovascular,
lung, or blood disease has had a fair chance of funding by Agency for Health
Care Policy and Research or other federal agencies. The Institute should
consider expanding such solicitations.
Institute-Initiated Research (Support-Review-Funding)
The Working Group is pleased with the indication that
the Institute will continue to encourage Investigator-initiated clinical trials
and will strengthen its advisory process (through the aforementioned
establishment of a Board of Extramural Advisors) to determine the
appropriateness and timeliness of Institute-initiated studies. The Working
Group is delighted with your unambiguous statement that staff cannot initiate
studies without the community involvement and the requirement that appropriate
documentation be developed to demonstrate the community's review of any
proposed new study.
The Working Group agrees that both Individual and
Institute-initiated studies are necessary as well as Cooperative Agreements,
but the continuing scientific community's input and oversight are essential.
This could possibly be part of the role of the new Board of Extramural
The Working Group appreciates the recognition by the
Institute of the sensitivity about the NIH-wide policy that investigators seek
its approval to submit applications exceeding $500,000 in any one year for
their project. We understand that the Institute is looking forward to exploring
with the Council approaches that can be used to minimize its deterrent effect
on investigator-initiated applications. In the meantime, the Working Groups
suggests that for grants of $500,000 or more, clear guidelines be defined by
the Institute for the criteria and the process used for approval of these
applications and the provision of scientific guidance from the Board or Council
representatives in situations where their approval by staff may be in jeopardy.
The Working Group is pleased with the Institute's
willingness to consider support for more than five years in truly exceptional
cases. It proposes that if support for longer than five years is contemplated
an interim period review for conditional continuation would be necessary.
The Working Group is pleased that the Institute shares
its views that further and expanded training opportunities must be developed
and that investigators pursuing population-based studies will be strongly
encouraged to involve the participation of individuals who are in the
development phase of their careers. The proposed creation of a new internal
structure to oversee the Institute's training programs and their responsiveness
to current needs is laudable. The Working Group have been particularly alarmed
about the paucity of biostatisticians, epidemiologists, and experts in
bioinformatics in the United States in contrast to what appears to be a Ph.D.
surplus of basic scientists with extensive postdoctoral training of up to 7 or
8 years and a paucity of available academic positions for the latter.
The Working Group wishes to cite a National Academy of
Science report on the seriousness of the deficit of 10,000 biostatisticians and
5,000 epidemiologists in the United States. Because of this, the Working Group
suggests a more emphatic response by the Institute possibly by providing
specific support for a training component, in the budget of population-based
studies to provide as it were, a "laboratory for training of new
The Working Group is pleased with the initiative of
the Institute in creating a new Board of External Advisors for implementation
possibly in the current fiscal year and the vision of the Institute that this
Board will provide much of the accountability and sustained outside input into
Institute programs that have been diminished in the last several years. The
broader representation on such a Board has the potential advantage of enhancing
awareness of complementarily and interdigitation of programs from various
divisions in the Institute, which could result in beneficial interactions.
As mentioned earlier under Goal D of this Addendum the
Working Group wishes to emphasize, however, that a critical mass of leading
cardiovascular epidemiology-prevention scientific expertise will be necessary
to provide the long-term accountability, oversight, and guidance that will
certainly be needed. Possibly subcommittees within this Board may address
specific missions of various divisions of the Institute.
The progress of such a Board in achieving its goals
and the Working Group's recommendation should guide its further direction once
The Working Group is pleased that there is more
interaction and integrative-program planning within DECA and between DECA and
other divisions than we had recognized. The proposed awards and retreat
programs and very careful oversight of the issue with explicit requirements of
continuous interaction among divisions as you propose would be very valuable. A
greater integrative influence exerted by the director of DECA over the efforts
of the program and research group levels would be very effective.
The Institute's response regarding the concern of the
Working Group with the participation of the staff in decision making about
programs supported by cooperative agreements and contracts is appreciated. The
Institute clearly recognizes the possible conflicts that may result from the
dual role of its staff as managers and collaborators. The Working Group is
pleased with the insistence that the existing provisions regarding these issues
would be adhered to by the divisions. We thank the Institute for updating its
policies on publication by staff members with appropriate rigor and oversight
and we support your plan to share the updated policy with investigators
including the steering committees of contracts and cooperative agreements if
1. The Working Group wants to share with Council our
endorsement of the Institute's plans and urges their implementation and the
consideration of the suggestions that have been made in this
Addendum during the implementation phases of the plans.
2. The Working Group requests on behalf of the Council
a report by the Institute to the February 2000 Council of the progress that
will have been achieved toward the initiatives described in the Institute's
3. The Working Group encourages a continuing dialogue
between the Institute and the Epidemiology and Prevention scientific community
to maintain the positive momentum that has been achieved.
4. We believe that in partnership, the Institute and
the Epidemiology and Prevention scientific community will address successfully
the health care challenges and opportunities of the 21st Century.
With the foregoing Addendum and our
October Report, and the suggestions for your consideration in the
implementation of all phases of the Institute's Response we now view the charge
of our Working Group completed.
Members of the
Working Group, for the
members of the Working Group:
Linda P. Fried, M.D.
Curt D. Furberg, M.D., Ph.D.
Charles Hennekens, M.D.
George A. Kaplan, M.D.
Shiriki K. Kumanyika,
Russell V. Luepker, M.D.
Karen A. Matthews, Ph.D.
Thomas A. Pearson, M.D.
Paul K. Whelton, M.D.
Overheads shown during the presentation of the
Addendum to the February NHLBI Council on February 4, 1999 are not included in
the Web version.