Background, Award Process and 1997 Award Summary

Breast Cancer Act Breast Cancer Research Program Breast Cancer Research Council Specific Goals for Cycle III  Scientific Review Basis for Funding Award Data

Breast Cancer Act

In 1993, the California Legislature passed, and the Governor signed, the Breast Cancer Act and enabling legislation (AB 1055 and AB 478), which established the Breast Cancer Research Program and the Breast Cancer Early Detection Program and funded these programs with the revenue from an increase (effective January 1, 1994) in the State tobacco tax. Former Assemblywoman Barbara Friedman authored these bills, as well as AB 3391 in 1994 and AB 2915 in 1995, which amended them. The tax revenue is deposited in the Breast Cancer Fund. Fifty per cent is allocated to fund early breast cancer detection services for uninsured and underinsured women through the Breast Cancer Early Detection Program (BCEDP) administered by the State Department of Health Services. Forty-five per cent is allocated to fund research on the cause, cure, treatment, early detection, and prevention of breast cancer through the Breast Cancer Research Program (BCRP). The remaining five per cent is allocated to the California Cancer Registry, which collects statewide data on cancer rates and deaths and compiles the statewide statistics on cancer in California.

Breast Cancer Research Program

The enabling legislation requested that the University of California establish and administer the Breast Cancer Research Program. The President of the University of California assigned specific responsibility for establishing and managing BCRP to the Vice President-Health Affairs, Cornelius L. Hopper, M.D. The BCRP is administratively part of the office of Special Research Programs, along with the Tobacco-Related Disease Research Program (TRDRP) and the Universitywide AIDS Research Program (UARP). All three programs are overseen by Charles L. Gruder, Ph.D., Executive Director of Special Research Programs. The CBCRP is directed by Marion H. E. Kavanaugh-Lynch, M.D., M.P.H.

top

Breast Cancer Research Council

The overall objectives, strategies, and priorities of the BCRP are set by the Breast Cancer Research Council. The Council consists of 15 members: 5 members from breast cancer survivor/advocacy groups, 5 scientist/clinicians, 2 members from non-profit health organizations, one practicing breast cancer medical specialist, 2 members from private industry and 1 ex-officio member from the Breast Cancer Early Detection Program. These members are appointed by the University of California, based upon recommendations from the Council and the community. Members serve for a term of three years without compensation, and are prohibited from seeking funding from the Program while on the Council and for one year afterwards. The Council is charged with developing the strategic objectives and priorities of the program, actively participating in the overall management of the Program and making final recommendations on which research grants should be funded based on the established priorities and the scientific merit of the proposals as determined by peer review panels.

top

Specific Goals for Cycle III

The BCRP’s goals are consistent with its broad mandate to reduce the human and economic costs of breast cancer in California. The program is also committed to funding research that is innovative, complementary to research funded by other agencies, and responsive to the concerns of the breast cancer constituency in California. To this end, in March 1996, the BCRP hosted an Advisory Meeting to gather advice and recommendations from stakeholders in the Program throughout the state (breast cancer advocates, health care providers, and research scientists from academia and industry) about the direction the program should take in funding breast cancer research. The Breast Cancer Research Council used the consensus recommendations from this meeting, information on the changing funding priorities of federal and local funding agencies, and the experience gained from the first two cycles to develop Cycle III priorities and funding mechanisms.

As in previous cycles, the choice of priority areas made by the Council was based on: 1) the importance of each area to the fight against breast cancer; 2) the Council’s sense of how funding from this Program will have the most impact on the human and economic cost of breast cancer in the state of California; and 3) the funding patterns of the federal government and other agencies. The changes made in response to feedback from the Advisory Meeting reflect a desire to: (1) challenge the research community to propose more innovative approaches to the problems of breast cancer, specifically including fostering collaborations among traditional research institutions and community groups; and (2) provide strong support for collaborative "translational" research, i.e., work whose results can be moved rapidly into practical application, whether through grass-roots organizations or mainstream health care providers.

The Breast Cancer Research Council, after careful deliberation, decided that the most effective use of the $14 million available in the third cycle was to focus research funding on a small number of key issues, targeting, to the extent possible, areas that are not as well-funded by the federal government and other agencies. Using guidance from the excellent exchange of views at the Advisory Meeting meeting, and recognizing the need to focus funding in a few research areas in order to best carry out its mandate in view of its limited resources, the Council adopted the following priority breast cancer research issues:

Support of scientists training for careers in breast cancer research was continued. The funding mechanisms that put emphasis on research training and early career development for this cycle are:

Postdoctoral Fellowship Awards - To provide individuals with doctoral degrees additional research training that will broaden their scientific background for research in breast cancer. These awards are for up to two years at a maximum of $35,000 per year average annual direct costs.

Sabbatical Awards - To enable established investigators to move into breast cancer research from another field or to explore an area of breast cancer research that is new for them. These awards are for one year at a maximum of $50,000, direct costs.

Two mechanisms for higher-risk research into heretofore relatively unexplored areas were also offered. These are:

Innovative Developmental and Exploratory Awards (IDEAs), Types I and II - To support developmental, exploratory, or pilot research, or high-risk/high-outcome research. These awards are for a maximum of one year and $50,000 in direct costs (Type I) or for a maximum of two years and an average of up to $75,000 per year in direct costs (Type II).

Innovative Treatment and Models of Care Awards (ITaMoCAs) - To support innovation in treatment or in health care services. These awards are for up to two years at an average of up to $100,000 per year in direct costs.

Two new mechanisms were developed to stimulate and support collaborative research – one for collaborations between experienced research scientists and community members/agencies (the CIRC Award), and one for collaborations between research scientists in different fields and institutions (the TRC Award). Both Awards were designed to offer a one-year Pilot Award to foster the development of teams and their projects, with larger awards for full projects to be offered in Cycle IV.

Community-Initiated Research Collaboration Pilot Awards (CIRC Pilots) – To stimulate and support collaborations between community organizations/members and experienced researchers to perform scientifically rigorous research into breast cancer-related problems that are identified as important by the community. The Pilot Awards are for up to one year and $75,000 in direct costs.

Translational Research Collaboration Pilot Awards (TRC Pilots) – To encourage inter- and intra-institutional commitment to innovative, translational research utilizing a cross-disciplinary approach. The Pilot Awards are for up to one year and $75,000 in direct costs.

Finally, the Council decided to set aside funds for awards in two areas identified as particularly important. Two million dollars was set aside for each of the two following topic-specific Requests for Application (RFAs). Awards were limited to three years, with no specified cap on the direct costs requested.

Basic Breast Biology Relevant to Development of Breast Cancer - This RFA encouraged studies aimed at achieving a greater knowledge of the normal breast, through all stages of development and change, in order to better understand anomalous changes that may lead to cancer.

Breast Cancer Prevention, Risk Identification and Risk Reduction – This RFA encouraged research that will enable more effective and appropriate prevention interventions by increasing our knowledge of modifiable breast cancer risk factors.

For all awards except the RFAs, no predetermined allocation was made, either to subject matter or award mechanisms. Rather, funding recommendations were based on the quality of the applications received and the desire to achieve a balanced portfolio of grants with respect to the priority areas.

Any investigator in California was eligible to be awarded a grant as long as the investigator met the requirements for the award mechanism and the research was to be conducted in California.

top

Scientific Review

The BCRP enabling legislation specifies that the procedure for evaluating research proposals be modeled on the one used by the National Institutes of Health. BCRP staff assembled "Review Committees" comprised of breast cancer patient advocates and researchers expert in the areas of the applications received. Reviewers and advocates were drawn from outside California in order to avoid both the occurrence and the appearance of conflicts of interest. (An exception to this are the advocate observers —one per committee— who are specifically recruited from within California.)

The membership of each Review Committee consisted of breast cancer researchers (selected as described above) and three or four breast cancer advocates. Two or three of the advocates were full voting members drawn from outside of California; the advocate observer did not vote. The council viewed the meetings as an opportunity for advocates to gain experience in the grant review process, and to be exposed to the most current issues in breast cancer research. The council was also interested in having the advisory viewpoints regarding the review process in preparation for reviewing priorities and mechanisms in Cycle IV.

Scientific reviewers are selected on the basis of their demonstrated competence and achievement as independent scientific investigators in specific breast cancer-related disciplines. The BCRP draws qualified individuals from as diverse a range of organizations as possible. Quality of research, professional service, and other scientific achievements and honors are considered in selecting members, as is the overall balance of perspectives on the review committee. Most members have served on other panels that review research proposals, although one or two less experienced individuals are usually placed on each review committee to provide a different perspective and give them experience. Review committee members are identified through numerous means, including rosters of NIH study sections, literature searches for publications in the appropriate research area, recommendations from Council members, other reviewers and other researchers in the area. Reviewers prepare written evaluations of proposals and meet, to discuss and vote on all applications assigned to that review committee. Applicants are provided with written summaries of the reviewers’ evaluations. The identification of the specific reviewers for each application is kept confidential, and the summary of the review is provided only to the applicant.

The grant applications received were evaluated by 101 peer reviewers in 6 Review Committees. The members of the various review committees that reviewed applications in Cycle III are listed later in this document.

top

Basis for Funding

The basis on which funding decisions were made was: (1) the scientific merit of the proposed research, as judged by the Review Committees; and (2) the balance of number and quality of applications in each priority area. In addition, special consideration was given to the following criteria:

innovativeness: the originality of the questions asked, and of the methods chosen to approach these questions.

multidisciplinary research: the incorporation of investigators and ideas from different fields of study to approach a problem in a new way.

translational potential: the potential of the research to be used in areas that result in clinical applications and/or have direct and immediate impact on the prevention or treatment of breast cancer.

focus on underserved populations: the potential of the work to reduce disparities in breast cancer incidence, morbidity, mortality or health care access among underserved populations.

The Breast Cancer Research Council arrived at recommendations of grants to be funded after considering the reviewers’ evaluations on the criteria the Council had specified. The University of California followed the Council’s recommendations in awarding these grants.

top

Award Data

BCRP awarded approximately $14 million in 66 grants to investigators at 24 California institutions and organizations. Award recipients include independent research institutes (e.g., SRI International), medical centers (e.g. California Pacific Medical Center), for-profit industry (e.g. Pangene Corporation), federal laboratories (e.g. Lawrence Berkeley National Laboratory), and universities (e.g., University of Southern California, University of California campuses). Awards commenced on June 1, 1997.

This compendium lists the funded grants by priority area including the project title, the principal investigator, the institution or organization, and the project abstract. Progress reports and final scientific reports of these and all CBCRP projects will be posted as they become available on our Homepage (http://www.cbcrp.org)

top