REPORT OF THE NHLBI COUNCIL
WORKING GROUP ON EPIDEMIOLOGY (1)
|January 7, 1998
||Letter from Lenfant to Abboud:
a Council subcommittee to review our Cardiovascular Epidemiology Program."
Concerns of the Institute:
- Epidemiologists differ in their support for
continuation of long-term observational studies vs. the exploration of newer
approaches to epidemiology, e.g., genetic epidemiology or subclinical disease
- "Doing everything that everybody wants is very
expensive" and may distort "allocation of resources among all the Institute's
- "Staff should not attempt to resolve the matter."
- "Council should investigate and review the matter .
. because it is one of its responsibilities to oversee the programs of the
|February 17, 1998
|| Charge: Lenfant to Abboud
"I would like the subcommittee to make recommendations to the
Institute on the directives we should sponsor and support and on the balance
between lengthy observational studies and other studies relying on the use of
new approaches and technologies."
1) Verbal report to Council
2) Letter summarizing the group's conclusions
WORKING GROUP ON EPIDEMIOLOGY
||Fried, Linda (Hopkins); Furberg, Curt (Bowman
Gay); Hennekens, Charles (Brigham & Women's Hospital); Kaplan, George (U.
Michigan); Kumanyika, Shiriki* (U. Illinois, Chicago); Luepker, Russell (U.
Minnesota); Matthews, Karen* (U. Pittsburgh); Oberman, Albert* (U. Alabama);
Pearson, Thomas (U. Rochester); Whelton, Paul* (Tulane); Abboud, Frank* (U.
||*Current or Past NHLBI Council Members
||MEETINGS AND CONFERENCES
| March 17
||Telephone conference (Kumanyika, Whelton, Abboud)
to select Working Group, define goals, and plan agenda
| March 18
||Meeting of Whelton and Kumanyika and Executive
Committee of the American Heart Association Council on Epidemiology and
Prevention to discuss issues of concern with NHLBI Staff (Santa Fe)
|| - Appoint Working Group
& telephone conference to define scope of Working Group
- Review of
- Review of previous Task Force Reports
||First Report to Council NHLBI
| May 28
||Telephone Conference of Working Group: Charge to
members and assignments of 5 written parts of report
|| Review and comments on the 5 parts of the report
by all members
| Sept. 4
||Second Report to Council NHLBI
| Sept. 30
||Telephone conference of Working Group
Discussion of components of the Draft Report
| Oct. 7
||Committee Meeting at O'Hare
- Review of Draft
- Discussion of issues with Drs. Lenfant and Friedman
| Oct. 7-21
|| Revision of Report by e-mail, FAX among
||Review of near final draft with NHLBI Council
EXHIBITS AND REFERENCE MATERIAL (Not
Included in the Web Version)
- Table of Organization of DECA
- Letter from Manolio regarding trends in
applications to NHLBI (No evidence of decline)
- Portfolio of Research Applications
- Summary of NHLBI Cohort Studies
- Epidemiology and Biometry Programs Active
Grants >$300,000 Direct Costs/Year
- DECA Inventory on Genetic Research
- Clinical Application and Prevention Program
Active Contracts and Grants >$300,000 Direct Costs/Year
- NIH Policy on $500,000 (March, 1998)
- Task Force Reports and SEPs
- NHLBI Report of the Task Force on Research in
Epidemiology and Prevention of Cardiovascular Diseases
- Report of the Task Force on Behavioral
Research in Cardiovascular, Lung, and Blood Health and Disease
- Minutes of the NHLBI Special Emphasis Panel on
Longitudinal Cohort Studies
CONCLUSIONS AND PROPOSED
The Working Group recognizes that the NHLBI has been
an outstanding resource for research and training in cardiovascular disease
epidemiology and prevention. Our goal is to suggest ways to maintain and
enhance the Institute's leadership role in the field. To that end we wish first
to reinforce two previous NHLBI Task Force Reports. The first
is the NHLBI Report of the Task Force on Research in Epidemiology and
Prevention of Cardiovascular Diseases (Aug. 1994)(2). This Task Force chaired by Al Oberman
included 18 leading experts in Epidemiology and Prevention and 4 consultants.
The second is the NHLBI Report of the Task Force on
Behavioral Research in Cardiovascular, Lung, and Blood Health and Disease (Feb.
1998)(3). The report was based on
deliberations of 16 leading experts and 4 consultants, chaired by Stephen
The Working Group urges further implementation of the
recommendations detailed in those two reports.
ln reviewing our charge it became
apparent that there were important concerns among the leadership of the
Epidemiology and Prevention Community that had to be addressed and shared with
the Council and the Institute.
Therefore this report represents not only
a response to our charge but also a sincere attempt to address constructively
issues that are essential to the future of research in Cardiovascular
Epidemiology and Prevention.
These issues are presented under 4
General Goals and 7 Programmatic and Procedural Strategies for consideration by
the Council and the Institute.
- Explore Novel and Unique areas in
- Use data from longitudinal cohort
studies as a resource for (1) new investigator-initiated proposals through
R01 or other mechanisms; (2) inter-Institute NIH-wide initiatives; (3)
- Identify genetic risk factors that
influence the response to traditional and non-traditional cardiopulmonary risk
factors and to interventions of these risk factors
- Identify subclinical disease for
- Enhance training opportunities
- Provide more leadership in the development
and fostering of prevention science in the area of cardiovascular
- Identify behavioral and social factors
that negate prevention
- Assure effective, meaningful
- Include both individual and
population-wide strategies for research
- Address primordial prevention
- Promote investigator-initiated clinical
- Foster maximum application of epidemiologic
and biostatistical methods as enabling strategies to the spectrum of
basic and translational research in heart, lung, and blood diseases
- Establish a scientific advisory subcommittee of
the NHLBI Council to work with staff on recommending priorities and
In an effort to achieve these goals our
Working Group offers four specific programs and three procedural opportunities
for review by the NHLBI Council and Institute.
|| Importance of Epidemiology/Prevention:
Resource Value of Cohort Studies
||The Need for More Clearly Defined Opportunities
in Translational Research
||Investigator-Initiated vs. Institute-Initiated
||Training of New Investigators
||Scientific Advisory Subcommittee of the
||Structure of DECA
We look forward to sharing and discussing the
NHLBI Council Working Group on
Our ultimate goal as NHLBI Council members, and as
physicians and scientists is to advise our government on the best way to
decrease the people's sufferings, morbidity, and mortality from Cardiovascular
In the midst of staggering advances in molecular
biology and genetics it is our collective responsibility to maintain a balanced
perspective and to recognize the continuing enormous importance of the science
of Epidemiology and Prevention of CVD among the spectrum of approaches to
achieve our ultimate goal.
Bridges between approaches:
Progress in the understanding and control of
cardiovascular diseases must be predicated on an appreciation that no single
approach or methodology can provide the sole answer to our questions. An
explanatory model that continually focuses at an increasingly molecular level,
while providing important insights, in itself may provide incomplete
information relevant to the control of cardiovascular disease. Furthermore, it
must be recognized that social, behavioral, and economic forces are the distal
causes of the proximal, molecular mechanisms in which there is so much
interest. That means that a full understanding of the causes and means of
prevention of cardiovascular disease is only present when there are bridges
built between all levels of investigation.
For example the different molecular/genetic defects
that can cause various types of hypertension or obesity will have much greater
significance once they can be coupled to specific phenotypes first in
transgenic mouse models but eventually and most importantly in human population
studies. Another example may be the phenotypic expression of a defective gene
that becomes evident only if enhanced by nutritional factors related possibly
The bridge is not just a one-way bridge from basic
research to epidemiology. Not infrequently epidemiologic studies raise
possibilities for laboratory research and molecular mechanisms, e.g., AIDS was
originally described through epidemiological studies that led to basic
It is similarly critical that a focus on the early
detection of cardiovascular disease and on its prevention in the community be
retained. While some investigations are better pursued with small,
unrepresentative samples they are not likely, in isolation, to lead to global
truths because their true significance can only be valued within a perspective
that assesses their importance within the population.
Within the preceding perspective, the
population-based, prospective epidemiologic study provides a unique window on
the potential causes and prevention of CVD. It provides a context in which the
molecular and the social/behavioral knowledge can be linked, in which the
determinants of risk factors can be studied, and in which the significance and
importance in the population of etiologic findings can be measured. Without
such studies we cannot hope to obtain the complete level of understanding
necessary to realize our greatest potential in the prevention and cure of heart
Overall, we view epidemiologic research as an
enabling science in the broadest sense and would hope that this broad view
would be shared by the NHLBI leadership and staff. As noted by Drs. Califf,
Pearson, and Hennekens in their July 22, 1998 letter to Dr. Lenfant, as
circulated to the SPARK Working Group, epidemiologic and biostatistical methods
have a unique and complementary role in advancing knowledge of heart, lung, and
blood diseases not only through the traditional route of population research
(e.g., descriptive and longitudinal observational epidemiologic studies and
randomized clinical trials), but also through patient-oriented clinical
research and health services research.
Resource Value of Cohort Studies
Longitudinal, population-based cohort studies
constitute an essential component of the spectrum of scientific inquiry.
They provide unique aspects of scientific information
on etiology, natural history, and consequences of disease, as well as the
generalizability and import of this information for human populations, by
studying both asymptomatic and symptomatic persons.
They define the predictive role of both short- and
long-term risk factors in human disease and the potential approaches to
prevention of disease likely to be effective for populations and subsets of the
They provide the opportunity to address important
multidisciplinary questions about complex biologic processes as well as to
understand the multifactorial origin of chronic diseases, and lay the basis for
identification of previously unrecognized risk factors with fewer sources of
bias and spurious results.
They permit understanding of the complex interaction
between genetic and environmental/behavioral factors and the subsets of the
population that may be at risk for disease or related adverse outcomes.
Thus, they not only provide a critical link in
scientific understanding of how molecular biologic research could affect the
future health of populations, but more broadly the range of most effective
approaches for prevention of disease.
As reported in the 1995 NHLBI
Special Emphasis Panel on Longitudinal Cohort Studies4 such prospective studies remain essential for
identification of new risk factors for, and consequences of, cardiac,
pulmonary, renal, cerebrovascular, peripheral vascular, and hematologic
diseases. They provide insights into potential areas for most effective
prevention, most cost-effective approaches to screening and intervention,
determining the impact of medical care on changes in outcomes over time and the
effectiveness of implementation of recommended medical therapies and preventive
Areas in which such research is
Areas in which research is particularly needed have
been identified by two NHLBI task forces. Their reports review recent advances
in research, identify high priority research opportunities, and make specific
recommendations regarding future research. These reports have been referred to
previously, in the Summary Statement, Conclusions and Proposed Recommendations.
Staff should be encouraged to consider how these recommendations help to
fulfill the NHLBI mission and how best to integrate them into the ongoing
planning on DECA as well as Institute-wide activities.
Longitudinal cohort studies are important to helping
- the study of subclinical disease (prognostic
import, measurement, and risk factors for its occurrence and progression);
- triggering of acute events;
- development of better, standardized definitions and
characterizations of angina, congestive heart failure and renal disease;
pulmonary and hematologic conditions;
- the role of diet and physical activity in these
health outcomes (and opportunities for improving measurement), as well as other
understudied behavioral factors including job strain, social networks and
- cross-disciplinary areas;
- the differences in risk factors, natural history
and disease outcomes for different racial, ethnic, and socioeconomic groups, as
well as the impact of differential receipt/use of medical care;
- role of environment and culture in adoption of
- utilization of genetic and molecular biologic
studies within such longitudinal cohort studies to define, in particular, the
nature of gene-by-environment interactions, and genetically at-risk subsets of
the population, as well as enhance understanding of etiology;
- understanding the effects of cardiovascular,
pulmonary and blood diseases on physical disability and cognitive function; the
potential for prevention of vascular dementia;
- understanding complex biologic processes that
result from interaction of several diseases, e.g. inflammation and diabetes;
atherosclerosis and hypertension; dementia, aging and cerebrovascular diseases.
Resource Value of Cohort
Results of longitudinal cohort studies also provide a
very rich substrate for important new questions that were not necessarily
anticipated at the initiation of the study. Such a use of established
populations is a potentially cost-effective way to develop new scientific
areas. To maximize the yield from established cohorts a range of approaches,
building on SEP recommendations, is proposed:
Obtain at regular intervals, the scientific
view of experts in the field and related fields to review the insights that
have been provided by recently completed epidemiologic studies and analyses,
clarify areas appropriate for direct progression to translational research and
define important questions to be pursued in further laboratory or population
- Ensure maximal analysis of data sets.
- Core investigators dedicated to answering the
initial objectives of a study would be, if productive, most likely to address
new goals because of their knowledge of the data set. These potential
efficiencies should be considered. Time for scientifically mining these data
sets should be considered a legitimate cost in support of these studies.
- A formal mechanism needs to be established to
make these data more widely available to the scientific community. It is
unlikely that just placing a database on a web site will lead to substantial-
or meaningful-usage. The data bases for these studies are generally highly
complex and thus preclude most investigators from being able to accurately
conduct analyses on their own. Therefore, mechanisms to enhance the analyses of
these data by external investigators might need to include core support to a
unit most effective in supporting these needs; for example the study's
biostatistical coordinating center could be charged with working with these
investigators, and providing necessary analytic support. Such a centralized
approach would help ensure the validity of the conclusions reached by
investigators not directly involved in the database creation.
- Encourage the development, and fiscal support,
of collaborative research groups -- from diverse universities -- organized to
address related research questions.
- Encourage the development of an RO1 mechanism to
extend longitudinal cohort studies at single sites. This will likely involve
ensuring that study sections are receptive to this, and understand how to
evaluate manuscript production in such studies.
- Use the cohort studies as an NIH-wide resource.
Establish a cross-Institute mechanism to examine potential of using results of
certain cohort studies to address important scientific questions generated from
The Need for More Clearly Defined
Opportunities in Translational Research
Better Translation of Research to the
There is an increasing gap between basic knowledge
and applied prevention.
Important information about prevention and treatment
of CVD already available (NEJM 1997;337:1360) must be applied more
systematically and broadly.
Many of the current preventive measures, known to be
effective, are not applied widely or effectively; for example, the inadequate
control of hypertension and inadequate use of lipid lowering agents coupled
with an estimated 50% long-term adherence to a drug regimen for those who do
The NHLBI should continue to develop and accelerate
strategic initiatives to maximize (1) the evaluation, in clinical and community
populations, of promising primary and secondary prevention hypotheses derived
from observational studies and (2) the scientific investigation of ways to
address problems in prevention, i.e., stimulating the necessary science at
whatever level is appropriate to the question.
Behavioral and life style factors are major causes of
morbidity and mortality, contributing to all the leading causes of death in the
US. Influencing people to adopt healthy behaviors cannot be achieved without
support for basic, clinical, and applied research efforts.
Emphasis is shifting to emerging nontraditional risk
factors, outcome measures, and patients in the community. Research
must be incorporated more effectively and quickly into preventive medical
practice in the community and public health practice at the state and local
Research in genetic epidemiology incorporating both
fundamental biology and population science is likely to be very rewarding in
the coming decade. It requires demonstration and education research to achieve
the safety and cost-effectiveness. The true value of genetic advances to human
health can only be understood through application in studies of human
populations. However, this should not be applied wholesale, but only when ready
Ultimately the medical implications and
economic savings can be huge with better translation of research to the
The Working Group recommends the following:
- Obtain sustained and broad external advice
on both clinical trial planning and prevention research and policy. Workshops
can not fulfill this need because of their limited scope and duration.
- Coordinate research efforts between
observational studies and intervention trials. This is best done at the NHLBI
level because monitoring exciting new findings in one domain could be picked up
as appropriate to other types of studies.
- To the extent that there may be concerns about
possible overlap with the missions of other NIH Institutes or Federal agencies
when stimulating or undertaking research to meet certain prevention goals,
clarify the real and perceived boundaries on what constitutes appropriate
research for the NHLBI and seek opportunities for formal partnerships with
agencies and institutes that have complementary missions (e.g., NHLBI-CDC;
NHLBI-Am Lung Assoc., etc.)
- The Institute should ensure that the
recommendations on prevention from major studies are synthesized and
- Develop a brief section in "continuing"
applications where investigators could identify findings likely to be helpful
to other domains.
- Address behavioral and social issues that limit
prevention. Several such issues can be addressed much more effectively if the
scientific interactions between the various programs of DECA were enhanced and
the research plans of the scientific research group were better integrated or
- Difficulty in generating epidemiology studies
that include substantial and novel behavioral input/hypotheses.
- Infrequent or delayed use of novel cohort
findings to promote the objectives and design of studies in prevention and
- Social and environmental epidemiology needs to
focus on both group-level variables (e.g., policies, community characteristics)
and individual-level variables and interactions between them.
- A process should be planned for keeping abreast
of emerging science in non-epidemiology disciplines (other than nutrition) and
their incorporation into the DECA activities.
The future of the field and the vision for research
come from the scientific community, that is, investigators who are on the front
line of the clinical and public health problems to be resolved through CVD
research and have the motivation and vision to ask creative, relevant questions
on a broad range of CVD topics. Success will depend however on a strong
partnership with a scientifically astute and managerially skilled, committed
and responsive staff. Staff will continue to be essential for the
administrative oversight and facilitation of an efficient research program of
the highest possible quality.
There is a perceived gradual increase in the
influence of NHLBI staff on the planning and direction of CVD epidemiology and
prevention without appropriate involvement from the scientific community. This
may have resulted from the loss of standing advisory committees to NHLBI, and a
relative increase in contracts and cooperative agreements resulting in part
from conversion of large investigator-initiated studies to cooperative
agreements. There is also a perceived emphasis on scientific productivity by
Investigator-initiated research support continues to
provide the optimal mechanism to stimulate creativity and quality from the
scientific community. The tendency to view separately the epidemiologic
research program of Institute-initiated studies from those that are
Investigator-initiated is an artificial division and may be misleading as to
the status of science in a given content area. Potentially understudied and
overstudied areas as well as potential intersections and economies among funded
studies in the Institute's epidemiologic study portfolios can best be
identified by considering the totality of funded research devoted to the topic
RFAs and RFPs should be initiated in priority areas
where Investigator-initiated mechanisms fail to stimulate scientific
initiatives. There seems to be a need also for a mechanism, which stimulates
multicenter collaborative proposals in priority areas without the constraints
of contractual or cooperative agreement mechanisms.
It is recognized that major longitudinal
inter-Institutional studies are likely to be initiated by Institute staff.
However, the initiation of single-site longitudinal cohort studies and the
continuation of some cohort studies should be encouraged through an
Mechanisms of review and
In considering the role of epidemiologic studies at
NHLBI, it is important to remember the many cohort studies are funded through
extramural, investigator-initiated efforts in addition to those that are
Institute-initiated. In many cases, these studies have provided critical and
important information. The record of publication of many of these studies is
comparable to that coming from the multi-center, Institute-based studies.
The requirement to seek administrative approval for
studies over $500,000 limits may represent an obstacle to such initiatives.
Concomitant with the administrative review by staff a scientific peer
perspective may be obtained from the proposed Scientific Advisory
Subcommittee of the Council. This may be necessary to counter the
perceived bias against continuation of established studies. The same Council
subcommittee could consider proposals of cross-discipline projects.
One model might be a program project grant, with different projects funded by
different Institutes and core NIH funding.
For the Investigator-initiated approach to be a
viable one for support of longitudinal cohort studies, it would be appropriate
to consider a period of support that is longer than 5 years but with some
interim peer review for conditional continuation. Support for a longer period
would greatly aid the investigators.
Careful consideration needs to be given to a more
efficient mechanism by which RFPs are generated, reviewed and approved. The
lengthy processes of pre-award submission and resubmission of RFPs and their
redesign after a successful bid occur sometime at a great cost to the potential
investigators. It is recognized that the process is mandated but there are
elements that are repetitive, time consuming, and ultimately unproductive in
that they involved detailed development and revision of protocols and plans
that are never utilized.
Another area for consideration is the lack of
suitable funding mechanisms for individual investigators to benefit from
longitudinal data from cohort studies in conjunction with coordinating center
personnel who can provide data and guidance about proper use of the data. Many
of the fortunately still numerous publications generated by studies such as
ARIC (Atherosclerosis Risk in Communities) and CHS (Cardiovascular Health
Study) are based on unfunded efforts of investigators who are interested in
questions that can be asked of the data. Because these efforts are unfunded
they are sometimes very slow in progressing and may be compromised by the
inability of the coordinating center to donate the necessary time and
Training of New Investigators
The goal of the Institute should be to develop the
needed scientific basis for epidemiology and prevention and to train the
scientists necessary to create this scientific base. Such training requires
emphasis on epidemiology, biostatistics, and study design -- from basic to
clinical research. Population studies allow great opportunities for training
clinical researchers and others by virtue of their collaborative nature
involving multiple centers and by implementing of epidemiologic techniques for
design, standardization of procedures and analysis. The requirement for
investigators from various disciplines seems integral to the evolving
concepts of CVD.
- The Need for Review of the NHLBI Training
There is a need to assess the current population of
trainees in cardiovascular epidemiology and prevention and related disciplines,
both in terms of quantity and quality. It is unclear if the needs are met by
current training programs. Various estimates by scientific organizations
suggest that there is a deficit of formally trained epidemiologists and
biostatisticians in the US. Those involved with recruiting and hiring these
scientists concur with this conclusion.
It is also unclear if current training programs are
training in subject areas in which manpower needs are likely to be the
greatest. If we are going to succeed in fostering genomics, computational
biology, emerging technologies, and imaging, population scientists will be
needed in these areas. These new investigators will not only need skills in
biostatistics, epidemiology, health services research, social and behavioral
sciences, and other quantitative methods, but will also need to be able to
apply these methodologic disciplines to prevention related research in addition
to classical epidemiology and biostatistical methodology.
There is also a great need for training in genetics
for individuals trained as epidemiologists to address the future compelling
questions in genetic epidemiology.
- Use NHLBI-initiated Studies as a Training
One creative approach to both maximizing research from
large NHLBI-initiated studies and providing training opportunities is to
encourage and support involvement of fellows and/or graduate students on
projects sponsored by contracts and cooperative agreements. Currently, if
budgets are perceived as tight, no funds are set aside to support graduate
students or fellows (unlike bench-related research where this is a ubiquitous
practice). The provision of additional funds (not reallocated moneys) for
trainees would benefit both the projects and the trainees.
The use of such a mechanism to attract new
investigators to ongoing studies for the purpose of initiating their careers is
recommended. It is increasingly difficult for persons just out of training to
establish careers in epidemiology and/or clinical research. While in bench
sciences, an institution can commit finite resources to create a laboratory for
a new investigator; it is difficult to create an epidemiology "laboratory" to
allow the investigator to create a track record in epidemiology and to develop
novel ideas. The attachment of such new investigators to large, established
epidemiologic databases and/or prevention programs will allow such career
The current stipend and salary levels may be low for
trainees, discouraging persons from pursuing fellowships or early faculty
career development awards. Review of NHLBI programs to assure concurrence with
other NIH Institutes and with the job market may be necessary.
Scientific Advisory Subcommittee of
Background: Concerns Regarding Review and
Long Range Planning Process
External Review of NHLBI-initiated Research.
Suggestions were made to enhance the accountability of initiatives proposed by
NHLBI staff. In the same way that externally initiated applications undergo
peer review, there should be a mechanism to review internally initiated
contracts. A standing body of advisors in epidemiology and prevention research
would review major NHLBI studies for the purpose of identifying new ideas and
opportunities and advise the Council. Such a group would be independent of the
studies' data safety and monitoring boards.
Creativity and Novelty. One concern about
long term epidemiologic studies and clinical trials is that funding is often
limited to low risk applications, which, by the time the data collection is
complete, no longer provide an expansion of knowledge. Mechanisms are needed to
infuse creativity and risk-taking into clinical trials and epidemiologic
studies. One comment made was the contrast between industry-supported trials as
creators of new knowledge versus NHLBI trials which are more likely to confirm
results already presented by others.
An issue frequently raised is the rule requiring
staff preview of applications which had a cost of $500,000 or greater. This was
felt to reduce investigator initiative and to dampen creativity in favor of
Sustained and broad external advice is needed on both
clinical trial planning and prevention research and policy. Workshops and SEPs
can not fulfill this need because of their limited scope and duration. There
should be a concerted effort to coordinate research efforts between
observational studies, and interventions best done at the NHLBI level. Exciting
new findings in one domain could be picked up as appropriate to other types of
studies. Continuation applications could have a brief section where
investigators could identify findings likely to be helpful to other domains.
Rationale for Creation of Subcommittee of
NHLBI staff and the quality of research generated by
the Institute have suffered because of the loss of regular and sustained input
from the scientific community. Such input which had worked effectively in the
past is essential if NHLBI staff are to perform effectively their jobs and
quality research in the interest of the health of the public is to be
Composition. The committee would comprise
ten members from the scientific community with recognized skills and expertise
in the disciplines represented by DECA as well as other disciplines.
Selection. Professional organizations in the
areas of epidemiology, public health, statistics, medicine and behavioral
science would nominate individuals from their organizations. Institute
officials would select from that group as well as other at-large sources, to
obtain representation from various disciplines. Recommendations would be
approved by Council. Council members with expertise in these areas could be
asked to serve on this committee.
Four-year terms with overlapping membership would
provide sustained input.
Frequency: The group would meet
three times per year.
Charge: To provide scientific input to
staff and advice to Council as follows:
- Review and recommend Institute initiated
research, collaborative agreements and contracts.
- Review and recommend to Council plans for
termination of contracts and collaborative agreements.
- Provide scientific input to staff and Council on
Investigator-initiated proposals over $500,000.
- Advise staff and Council on areas/topics of
- Provide and maintain a long-range perspective on
areas of research priorities.
Structure of DECA
The Working Group recommends a review of the structure
and operations of DECA to optimize a broader representation and greater
communication among related disciplines that contribute to the missions of
epidemiology and prevention.
Current Structure of DECA
The Division provides administrative oversight of
three programs related to epidemiology, prevention and biostatistics. The
epidemiology and clinical trials as well as prevention programs related to
diseases of the lung and blood are not administered through DECA, but rather
through the Lung and Blood Divisions, respectively.
The Epidemiology and Biometry Program directed by
Teri Manolio has several groups including the social and environmental
epidemiology scientific research group; the analytical resources scientific
research group; the field studies and clinical epidemiology scientific research
group; the Framingham epidemiology research unit; and the genetic epidemiology
The second program on Clinical Application and
Prevention directed by Jeff Cutler includes the prevention scientific research
group; a clinical trials scientific research group and a behavioral medicine
scientific research group. It is our understanding that the behavioral medicine
research group focuses on basic research and clinical trials. The resources and
perspectives of that group can be very useful for other research groups and
The third program is on Biostatistics directed by
Nancy Geller. It is a resource for all programs and overlaps in function with
the analytical resources scientific research group. In addition, there is the
nutrition coordinator who reports directly to the director of DECA and to the
Director of NHLBI.
The Working Group believes that the breadth of what
is defined as epidemiology at the NHLBI seems too tied to the discipline of
epidemiology. Future directions should be broadened to include all the goals
and programmatic initiatives outlined above.
The major limitations may be both structural and
The expectation is that a revised structure would
allow much more frequent communication and exchange of ideas among the staff,
more frequent attendance at scientific meetings and more time for interaction
and consultation with the scientific constituency. If a significant change in
structure is not optimal then a process for more frequent interactions and
integrated program planning among the various scientific research groups within
DECA and other divisions is essential.
Sharing of expertise and resources for epidemiologic
and intervention studies within DECA and between DECA and the Lung and Blood
Divisions would be beneficial to all, increase efficiency, and create a more
A greater integrative influence should be exerted by
the Director and Deputy Director over the efforts at the Program and research
The role of the staff as managers of science vs. a
collaborating scientists should be addressed. Under most circumstances the
managerial role would be the primary responsibility of the staff. However the
staff needs to maintain scientific interest and expertise to be a most
effective advocate for the programs. It does seem reasonable that opportunities
for collaborative science be made available to the staff.
Several concerns were expressed regarding a potential
conflict of interest which may be present in the involvement of the contract or
cooperative agreement manager as a participating scientist. The interaction of
the staff with the investigators on a project is one of accountability and
control over budget when the staff is functioning as manager of the contract or
cooperative agreement. This contrasts with the collegial interaction expected
from a co-investigator or a collaborative scientist. This potential conflict
should be addressed by a policy to be developed by the Institute defining
guidelines under which scientific collaboration would be acceptable.
Clarification of the role of and expectations from
staff will promote the essential .cooperative and mutually supportive
partnership between staff and investigators.
1. An Addendum to this
Report, dated February 1999, was prepared as a follow-up to the NHLBI response
to this Report. [Return to
2. Recommendations are listed on p. 12 and 13 of the
Executive Summary. They include five strategic emphases and eight priority
areas for both epidemiological research on causation and enhanced application
of already available knowledge for primary and secondary prevention of
cardiovascular disease. [Return to
3. On pages 20-25 of that Task Force Report are
listed 12 recommendations including the incorporation of behavioral science
into existing epidemiological and clinical studies, developing interventions to
sustain improvements in lifestyle risk factors and adherence to treatment, and
incorporate genetic research strategies. (February, 1998). [Return to text]
4. Refer to Minutes of the NHLBI Special Emphasis
Panel on Longitudinal Cohort Studies (Sept. 5-6, 1995). [Return to text]