We have organized this section into funding for clinical trials at the level of the local institution, funding from foundations and professional societies, funding from industry, and finally funding from federal sources, including the NIH, the NCI, and the Department of Defense. Investigators should understand that they may well need to assemble financial support from a variety of different sources to support their clinical trials.
Institutional Funding for Clinical Trials
Investigators seeking to start trials for women with breast cancer at their home institution should first find out what resources exist to support and manage trials. Collegial relationships with the staff of the institutional Clinical Research Office and IRB are critical. New investigators should find out whether there is institutional support for trial biostatistics, data management, research pharmacy services, core laboratories, trial education, and community outreach for trials. As noted earlier, in some cases, the indirect costs associated with grants or contracts may cover all or part of these activities. In addition, many institutions do have small grant programs that provide seed money for new investigators.
Foundation and Professional Society Funding for Clinical Trials
A number of foundations and professional societies have ongoing programs to support cancer research, including clinical trials. Some of those most likely to support breast cancers trials are shown in Tables 41-1 and 41-2. Funding mechanisms, dollars, and deadlines can change from year to year, so investigators should check for updates regularly with these organizations. The Community of Science provides a comprehensive electronic database of funding sources for scientific research.13 Many institutions have research offices that can provide guidance on potential funding sources from all sites, including foundations.
Table 41-1 Partial List of Foundations Which May Consider Supporting Clinical Trials in Breast Cancer
Table 41-2 Partial List of Professional Societies with Grant Programs That May Be Appropriate for Support of Clinical Trials in Breast Cancer
Pharmaceutical and biotechnology companies provide a large amount of support for research, including clinical trials. The Pharmaceutical and Manufacturers Research Association estimated that in 2007 research and investment in new drugs totaled at least $55.8 billion.14 These include both company-sponsored trials, as well as investigator-initiated trials. Some large companies have grant programs to provide experimental agents and, in some cases, additional financial support for investigator-initiated trials. Investigators undertaking clinical trials under contract with industry should ensure that the contracts include appropriate funding at the institutional levels for the costs described in the first section of this chapter.
National Institutes of Health
Through the National Center for Research Resources, the NIH has 2 major programs of importance to clinical trialists. These both provide support at the institutional level for aspects of clinical trials. The General Clinical Research Centers help pay for the costs of research nurses, data managers, biostatisticians, hardware, and software, as well as underwriting patient care costs associated with clinical trials that are not part of routine patient care, including additional overnight stays, imaging studies, and laboratory studies. A list of those 78 institutions that have General Clinical Research Center grants may be found at the National Center for Research Resources Web site.15 In general, each institution has an application process by which an investigator can apply for funds to cover the additional patient care costs associated with clinical trials. The Clinical and Translational Science Awards (CTSA) program provides institutional funding to strengthen clinical and translational research at academic health centers.16 The funding will be used to train new investigators, design new informatics tools for clinical trials, support outreach to the public and health care providers, build interdisciplinary research teams, and build new partnerships with public and private health care organizations, including the pharmaceutical companies, the Veterans Administration hospitals, health maintenance organizations, as well as state health agencies. Currently, the CTSA consortium includes 38 academic centers in 23 states. In 2012, when the program is fully implemented, the consortium will include approximately 60 CTSAs with an annual budget of $500 million.
National Cancer Institute
NCI funding for clinical trials can be divided into support for training in clinical research, support for investigator-initiated clinical trials, and ongoing support for clinical trials network. The NCI currently supports Institutional Research Training Grants for young investigators at many sites.17 NCI individual grants for training in clinical trials span early, transition, and mid-career. A list of the various grant mechanisms may be found at the NCI Cancer Training Web site.18 Another useful Web site is the NIH Career Award Wizard.19 The NCI has also earmarked money to support the training of underrepresented minorities in clinical trials through the Comprehensive Minority Biomedical Program, using both institutional and individual award programs.20
The NCI supports investigator-initiated clinical research through a variety of grant mechanisms. The smallest is the R03, which can be used to support correlative science linked to a clinical trial. Next comes the R21, which is used to support small developmental trials. A larger grant, which could incorporate both clinical trials and the associated translational research, would be the R01. The largest grants are the Program Project (PO1), which consists of several related projects, and the cancer-site-specific SPORE. Currently the NCI funds 11 SPOREs in breast cancer.21 Many of these have undertaken early-phase clinical trials in breast cancer. Investigators should check the NCI Web site for relevant program announcements, indicating NCI interest (but not earmarked money) and requests for applications (RFAs), for which the NCI has set aside money.22 Two Program Announcements that breast cancer investigators should note are the Quick Trials program announcement for small trials of novel cancer therapies and the program announcement for correlative studies from multisite clinical trials.5,23 It is important to note that due to budgetary limitations, NIH and NCI grants have been cut back to 85% of approved funds, highlighting the need for investigators to put together funding from a variety of sources for an individual clinical trial.
The NCI also funds several ongoing consortia for clinical trials. These include sites that conduct phase 1 trials of novel agents for cancer treatment under contract, as well as a larger consortium that conducts phase 2 trials of novel agents for cancer treatment. Definitive phase 3 cancer treatment trials are largely conducted by the NCI's Clinical Trials Cooperative Groups. Table 41-3 shows those groups that conduct trials in breast cancer. The NCI has established a separate but overlapping consortium, composed of academic centers linked to community physicians to develop and conduct trials in cancer control and prevention.24 Sites that are funded to develop such trials, termed Community Clinical Oncology Program (CCOP) Research Bases, include the Clinical Trials Cooperative Groups marked with an asterisk in Table 41-3, as well as the institutions listed in Table 41-4. Community sites that are funded to participate in cancer control, prevention, and treatment trials through the CCOP and Minority-Based CCOP program are listed at the NCI CCOP Web site.25
Table 41-3 NCI-Sponsored Clinical Trials Cooperative Groups That Conduct Trials in Breast Cancer
Table 41-4 Additional Community Clinical Oncology Program Research Bases
We encourage breast cancer investigators to take advantage of the ongoing support for research infrastructure from NIH and NCI described here. Trialists should explore what NIH and NCI support for clinical research exists at their current institution, as well as at institutions where they may be seeking employment. The extensive clinical trials infrastructure represented by the NCI's Clinical Trials Cooperative Groups and CCOP program is ideal for conducting breast cancer prevention, treatment, and symptom control trials.
The Department of Defense sponsors research in breast cancer through the Congressionally Directed Medical Research Programs.26 Funding mechanisms and priorities can change from year to year, so investigators should check for updates with Congressionally Directed Medical Research Program staff and the Web site.