Background, Award Process and 1998 Award Summary
The California Breast Cancer Research Program (BCRP) is pleased to present the recipients of grant funding for Cycle IV. In this Chapter a history of the BCRP, its mission, the grant application review process, a review of the different award types, and an overview of funding is presented. In following Chapters the research project abstracts are organized by the individual breast cancer ‘Priority Issues’ developed by the BCRP. We welcome your interest as Californians concerned about breast cancer.
Breast Cancer Act
In 1993, the California Legislature recognized the need for the State to respond to the crisis of breast cancer and passed the Breast Cancer Act and enabling legislation (AB 1055 and AB 478), which established a three-pronged approach to reducing the impact of breast cancer in California. The legislation created the BCRP and the Breast Cancer Early Detection Program (BCEDP) and funded these programs with the revenue from an increase in the State tobacco tax (effective January 1, 1994). Forty-five per cent of the tax revenue is allocated to fund research on the cause, cure, treatment, early detection, and prevention of breast cancer through the BCRP, administered by the University of California; fifty per cent is allocated to fund breast cancer early detection services for uninsured and underinsured women through the BCEDP, administered by the State Department of Health Services; and the remaining five per cent is allocated to the California Cancer Registry, which collects and compiles statewide data on cancer rates, survival, and deaths in California.
Breast Cancer Research Program
The BCRP was established at the University of California to spearhead efforts to stimulate innovative and creative breast cancer research that complements, but does not duplicate, research funded by other agencies.
From its conception, the Program has been a partnership between all Californians concerned about breast cancer. Legislators, breast cancer advocates, academic and biotechnology scientists, clinicians, and University of California officials worked together to draft the enabling legislation. Representatives of these same constituencies serve to advise the Program on research priorities and grant funding; similarly diverse groups are convened to review grant applications. Research grants are awarded to scientists across the state working in public and private universities, research institutes, hospitals and medical centers, community agencies and biotechnology companies.
The BCRP also encourages research partnerships and collaborations. The Program has created innovative initiatives to ensure that funds are directed towards research that is meaningful to Californians and that will result in rapid implementation to make a difference for patients. One of these initiatives, the Community-Initiated Research Collaboration, funds teams of community groups/agencies and experienced scientists to explore issues of concerns to the community. Another initiative, the Translational Research Collaboration, funds teams of scientists from different disciplines and institutions to explore new ideas and translate them to practice. Thus, new research ideas are brought quickly from the bench to the bedside, from the research setting to the community. These new initiatives are among the new portfolio of grants funded July 1, 1998.
Breast Cancer Research Council
The overall objectives, strategies, and priorities of the BCRP are developed by the Breast Cancer Research Council. The Council normally consists of 16 members. As shown by the listing in Chapter 10, the Council includes representatives from a variety of California breast cancer ‘communities’- including survivor/advocacy groups, scientist/clinicians, non-profit health organizations, private industry, a breast cancer medical specialist, and an ex-officio member and alternate from the Breast Cancer Early Detection Program. Council members are appointed by the University of California, based upon recommendations from the Council and the community.
The Council is charged with developing the strategic objectives and priorities of the Program, actively participating in its overall management, and making final recommendations on grant funding based on the research priorities and the scientific merit of the proposals as determined by peer review committees.
Research Funding Goals for 1998- Cycle IV
The BCRP’s goals are consistent with its broad mandate to reduce the human and economic costs of breast cancer 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 three BCRP funding cycles to develop Cycle IV priorities and funding mechanisms. In general, the Program’s priorities reflect a desire to: 1) challenge the research community to propose more innovative approaches to the problems of breast cancer, including fostering collaborations among traditional research institutions and community groups; and 2) provide strong support for "translational" research, i.e., work whose results can be moved rapidly into practical application, whether through grass-roots organizations or mainstream healthcare providers.
The BCRP Priority Issues for Cycle IV are to develop and enhance our understanding of:
- basic breast biology relevant to breast cancer
- the etiology of breast cancer
- the pathogenesis of breast cancer
- new approaches to prevent breast cancer
- effective techniques for the earlier detection of breast cancer
- access to services for the early detection of breast cancer
- innovative models of care
- innovative treatment modalities
The support of scientists early in their careers has been a goal of the Program since its inception. The award types fostering research training and career development are:
The Program has been directing more funds each year for speculative and innovative research that has a potential for high impact on breast cancer. The award types for ‘higher-risk’ research into relatively unexplored areas 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
either for a maximum of one year and $50,000, direct costs (Type I) or for
a maximum of two years for 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 either 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 novel award types, first developed for Cycle III, were continued to
ensure that funds are directed towards research that is meaningful to Californians
and that will result in rapid implementation to make a difference for patients.
First, the Community-Initiated Research Collaboration funds teams of community
groups/agencies and experienced scientists to explore issues of concerns
to the community (i.e, groups of women impacted by breast cancer). Secondly,
the Translational Research Collaboration funds teams of scientists from
different fields and institutions to explore new ideas and translate them
to practice. Thus, new research ideas are brought quickly from the bench
to the bedside, thus moving from the research setting to the community.
Community-Initiated Research Collaboration (CIRC) Awards: 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. These grants have co-PIs that represent both the community organization and the scientist research partners. Pilot Awards are for up to one year and $75,000; Full Research Awards are for up to three years and $500,000 total direct costs.
Translational Research Collaboration (TRC) Awards:
to encourage inter- and intra-institutional commitment to innovative, translational
research utilizing a cross-disciplinary approach. These grants have co-PIs
that represent different breast cancer research disciplines. Pilot Awards
are for up to one year and $75,000; Full Research Awards are for up to three
years and $500,000 total direct costs.
Finally, the Council set aside funds and issued a Request for Applications
(RFA) in three research areas identified as particularly important.
Basic Breast Biology relevant to the development
of breast cancer. This RFA encourages studies aimed at achieving a greater
knowledge of the normal breast, through all stages of development and change,
in order to better understand how these changes may lead to cancer.
Breast Cancer Prevention, Risk Identification and Risk Reduction. This RFA
encourages research that will enable more effective and appropriate prevention
interventions by increasing our knowledge of modifiable breast cancer risk
factors.
Socio-Cultural, Behavioral and Psychological Issues
relevant to breast cancer. This RFA encourages qualitative and quantitative
research into personal, human issues affecting women with respect to the
risk or occurrence of breast cancer.
Any investigator in California was eligible to be awarded a grant as long
as the investigator met the requirements for the award type and the research
was to be conducted in California.
Scientific Review
The BCRP procedure for scientific review of applications is modeled on the National Institutes of Health procedure, with modifications adopted to: (1) emphasize the inclusion of representatives from all stakeholders involved in the eradication of breast cancer; and (2) foster funding of highly innovative research.
The BCRP staff assembles review committees, comprised of breast cancer patient advocates and researchers expert in the areas of the applications received. Reviewers are drawn from outside California in order to avoid both the occurrence and the appearance of conflicts of interest.
Scientific reviewers include prominent breast cancer researchers, biotechnology scientists, oncologists, surgeons, nurses, public health practitioners, and scientists with expertise in different fields, and are selected on the basis of their demonstrated knowledge 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 in committees (i.e., study sections) to discuss and score all applications. Applicants are provided with written summaries of the reviewers' evaluations. Confidentiality is maintained in all aspects of the review process, and selected information is released only on funded projects.
Applications are evaluated and voted on by the Committees for independent scientific merit score components that vary according to the different award types. These scores are the basis for the initial ranking of applications by award type within each Committee.
In addition, grant applications are evaluated and considered for their:
- 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 California populations and communities.
Applications are analyzed by the Review Committees and Program staff for (i) compliance with regulations covering the use of human and animal subjects, (ii) overlap with other funding support, (iii) eligibility of the principal investigators, and (iv) issues related to distribution of research overhead (indirect costs).
The Review Committee rosters and a description of the different roles of committee members are shown in Chapter 9.
Basis for Funding
The Program provides the Review Committee scoring and written evaluations to the Breast Cancer Research Council. The basis for funding decisions by the Council include: (1) the scientific merit rankings, innovativeness and potential impact of the proposed research, as judged by the Review Committees; (2) the specificity and relevance to the priority areas identified by the Council; and (3) the balance of number and quality of applications across award types, priority areas and research topics.
The University of California approved the Council's recommendations in awarding these grants.
Summary of Funded Research
In 1998, BCRP awarded more than $17 million in 51 grants to investigators at 27 California institutions and organizations. Award recipients include community agencies (e.g., The Wellness Community), independent research institutes (e.g., The Salk Institute for Biological Studies), medical centers (e.g., California Pacific Medical Center), federal laboratories (e.g., Lawrence Berkeley National Laboratory), and public (University of California campuses) and private universities (Stanford University). A listing of funded institutions is provided in Chapter 12.
Awards commenced on July 1, 1998. These included:
3 grants to expand our knowledge of the biology of the normal breast, including how it develops and how it changes during pregnancy.
11 grants to investigate identification and prevention of factors that increase the risk of breast cancer, including exposures to radiation; preventive effects of grape juice; and the interaction of physical activity and hormones.
17 grants to further understanding of how breast cancer develops, including identifying new breast cancer-related genes, examining the interactions of breast cells with their immediate environment, and determining actions of hormones and hormone-blocking drugs.
12 grants to develop new treatments for breast cancer, including treatment tailored to individual women’s tumors, new drugs to prevent new blood vessel growth into tumors, and finding ways to boost the immune system to fight breast cancer.
5 grants to explore better ways to meet women’s needs, especially among underserved populations, including African Americans, Samoans, women with disabilities, and older women.
3 grants exploring socio-cultural, behavioral, and psychological aspects of breast cancer.
6 grants to teams of community members/organizations and research scientists focused on issues identified by, and important to, communities in the state, including women with disabilities, lesbian women, and American Samoans.
5 grants to cross-disciplinary teams of research scientists focused on bringing results of scientific research into practical application, including the use of mobile mammography, timing of surgery and tailoring of chemotherapy to tumor characteristics, and developing and implementing new counseling methods for women at higher risk of breast cancer.
13 grants to new investigators in breast cancer to establish their careers in areas that will make an impact in breast cancer.
6 fully developed research grants in areas that have been identified as relatively under-funded, but important to advance our knowledge of breast cancer.
20 grants to explore new, innovative concepts that may open up new avenues for breast cancer research and new options for prevention, detection and treatment of breast cancer.
With these new awards, the California Breast Cancer Research Program has invested more than $60 million in breast cancer research since 1994. These funds support research projects and training of both beginning and experienced scientists; they support efforts in laboratories, in clinics and in communities. It is perhaps too early to draw conclusions about the research funded in the previous four years, but it is not too early to recognize that California is once again leading the country as it develops new models for research. The funds that the state of California has invested provide critical leverage in developing new scientific infrastructure and networks crucial for a comprehensive approach to eradicating breast cancer.
In the following sections an overall perspective of grant funding is presented by BCRP priority issue, and the individual project titles, principal investigator(s), institutions, and abstracts are provided. The abstracts are organized by award type, which were described earlier in this Chapter.
