Background, Award Process and Summary
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 in the State tobacco tax (effective January 1, 1994). Assemblywoman Barbara Friedman authored these bills, as well as AB 3391 in 1994 and AB 2915 in 1996, which amended them. The tax revenue is deposited in the Breast Cancer Fund. Fifty per cent is allocated to fund breast cancer early 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 and compiles statewide data on cancer rates and deaths 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). Grants may be awarded to public, private or non-profit agencies, organizations, or individuals in California for research or research career development in the state.
The BCRP's goals are consistent with the goal of the enabling legislation to reduce the human and economic costs of breast cancer in California. The Breast Cancer Act calls for funding innovative and creative breast cancer research that complements - rather than duplicates - research that has been funded by the federal government and other agencies.
Breast Cancer Research Council
The overall objectives, strategies, and priorities of the BCRP are developed by the Breast Cancer Research Council. The Council consists of 16 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 afterward. 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.
Specific Goals for Cycle II
The Breast Cancer Research Council, after careful deliberation, decided that the most effective use of the $14 million available in the second cycle was to concentrate research funding on a small number of key issues, focusing, to the extent possible, on areas that are not as well-funded by the federal government and other agencies.
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. In advance of the first cycle, the Council and BCRP staff convened a meeting of nationally-recognized breast cancer experts, including survivor/advocates. Using guidance from the excellent exchange of views at this 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 for Cycle II:
- enhanced understanding of the etiology and pathogenesis of breast cancer
- development of more effective techniques for the earlier detection of breast cancer
- development of new approaches to prevent breast cancer
- increasing access to services for the early detection of breast cancer
- development of innovative models of care
- development of innovative treatment modalities
Support of scientists early in their careers, identified as a need at the July, 1994 meeting, was continued. The funding mechanisms (which put emphasis on research training and early career development) for this cycle are:
New Investigator Awards
To support newly independent investigators at a level that is sufficient to enable them to initiate their own research programs. These awards are for a maximum of three years at up to $75,000 per year, average annual direct costs.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 other fields, or to explore areas of breast cancer research that are new for them. These awards are for one year at a maximum of $50,000, direct costs.Training Program Awards
To enable educational programs to train graduate or undergraduate students for research careers in disciplines which are important to breast cancer research. These awards are for three years, to support from three to five trainees, with maximum stipends of $10,000 per 12 months for undergraduates, or $15,000 per twelve months for graduates.
One mechanism, offering support for research of important cancer research issues generally undertaken by established investigators, and two others for higher-risk research into heretofore relatively unexplored areas, were also offered. These are:
Research Project Awards
To support fully-developed, investigator-initiated research projects in the identified priority areas. Awards are available for up to three years and up to $100,000 per year ($125,000 per year for awards in the fields of epidemiology and social/behavioral research), average direct costs.Innovative Developmental and Exploratory Awards (IDEAs)
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, direct costs.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.
As in the first Cycle, the Council did not recommend advance allocation of the money available according to either subject matter areas or award mechanisms, but rather based funding recommendations on the number and quality of the applications received and on achieving a balanced portfolio of grants with respect to the priority areas established.
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.
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 were drawn from outside California in order to avoid both the occurrence and the appearance of conflicts of interest.
Scientific reviewers are selected on the basis of their demonstrated competence and achievement as independent scientific investigators in specific breast cancer-related disciplines. 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. Scientific reviewers are identified through numerous means, including rosters of NIH study sections, literature searches for publications in the appropriate research area, and recommendations from Council members, other reviewers and other researchers in the area. Advocate reviewers are selected from recommendations made by breast cancer advocacy organizations and Council members. Reviewers prepare written evaluations of proposals and meet to discuss and score 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 membership of each review committee consisted of breast cancer researchers (selected as described above) and three breast cancer patient advocates; members were drawn from throughout the U.S. Two of the advocates were full-voting members drawn from outside of California; the role of the third (non-voting) advocate, who was from within the state was to act as an observer and help the Council and BCRP evaluate the review process. Reviewers designated as "ad hoc" evaluated only one or two applications and did not attend the meeting.
The grant applications received were evaluated by 122 peer reviewers in 8 review committees. The members of the various review committees which reviewed applications in Cycle II are listed later in this document.
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 approach: 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 which result in clinical applications and/or have direct and immediate impact on the prevention or treatment of breast cancer (where applicable).
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.
Award Data
BCRP awarded nearly $14 million in 60 grants to investigators at 23 California institutions and organizations. Award recipients include independent research institutes (e.g., The Burham Institute), medical centers (e.g. Sidney Kimmel Cancer Center), for-profit industry (e.g. Nova R & D, Inc.), federal laboratories (e.g. Lawrence Berkeley National Laboratory), and public (University of California campuses) and private universities (Charles Drew University of Medicine and Science). Awards commenced on June 1, 1996.
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 projects will be posted, as they become available, on the California Breast Cancer Reasearch Program's Home Page.
