February 1999

ADDENDUM TO THE REPORT OF THE NHLBI COUNCIL'S WORKING GROUP ON EPIDEMIOLOGY OF OCTOBER 1998

Contents
GOALS
	Goal A. Explore Novel and Unique Areas in Cardiovascular Epidemiology
	Goal B. Provide More Leadership in the Development and Fostering of Prevention Science in the Area of Cardiovascular Disease
	Goal C. Foster Maximum Application of Epidemiologic and Biostatistical Methods as Enabling Strategies to the Spectrum of Basic and Translational Research in Heart, Lung, and Blood Disease
	Goal D. Establish a Scientific Advisory Subcommittee of the NHLBI Council to Work with Staff on Recommending Priorities and Initiatives
PROGRAMS
	Program 1. Importance of Epidemiology/Prevention and Resource Value of Cohort Studies
	Program II. The Need for More Clearly Defined Opportunities in Translational Research
	Program III. Investigator-Initiated vs. Institute-Initiated Research (Support-Review-Funding)
	Program IV. Training of New Investigators
PROCESS
	Process 1. Scientific Advisory Subcommittee
	Process II. Structure of DECA
	Process III. Staff Role
SUMMARY

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.

The Addendum is intended to:

1. Endorse the Institute's Response to the Working Group's (WORKING GROUP) Report and support the momentum that has been initiated.
   
   
2. 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 Institute's Response

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---"

Goal A.	Explore Novel and Unique Areas in Cardiovascular Epidemiology:
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.

Goal B.

Provide More Leadership in the Development and Fostering of Prevention Science in the Area of Cardiovascular Disease.

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.

Goal C.

Foster Maximum Application of Epidemiologic and Biostatistical Methods and Enabling Strategies to the Spectrum of Basic and Translational Research in Heart, Lung, and Blood Disease.

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.

Goal D.

Establish a Scientific Advisory Subcommittee of the NHLBI Council to Work with Staff on Recommending Priorities and Initiatives.

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 and prevention.

Program I.

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.

Program II.

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.

Program III.

Investigator-Initiated vs. 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 Advisors.

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.

Program IV

Training of New Investigators

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 investigators."

Process I.

Scientific Advisory Subcommittee

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 established.

Process II.

Structure of DECA

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.

Process III.

Staff Role

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 possible.

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 Response.

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.

Overheads shown during the presentation of the Addendum to the February NHLBI Council on February 4, 1999 are not included in the Web version.