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Accelerate discoveries and their application by expanding and facilitating researcher access to resources and new technologies.
Investigator-initiated research - research independently conceived and developed by scientists - has always been the primary means by which biomedical research is funded and conducted. Driven by the synergism at medical schools, hospitals, universities, and research centers, these investigators ask the critical questions, explore the options, develop and test innovative technologies, and make the discoveries that lead to better cancer science and its application to patient care. Investigator-initiated research is:
- The principal means by which scientists address high-priority goals, such as those identified by the Progress Review Groups focused on specific types of cancer.
- A mainstay for cancer research training and for enabling multidisciplinary collaboration.
Providing Resources to Maximize Investigator Productivity
Science is changing rapidly, and the promise and problems of research are changing along with it.
- In many areas, a single laboratory can easily accomplish goals that would have been unapproachable only a few years ago. This is due to the availability of vast amounts of information as well as new tools and techniques for analysis.
- The genetic makeup of cells and tissues, as well as complex gene expression patterns, can be analyzed in exquisite detail, and methods to analyze proteins and other cellular components are developing rapidly.
- Methods for discovering and analyzing promising drugs aimed at cancer-causing pathways have outfitted scientists with an arsenal of research approaches and technologies more comprehensive than any previously available.
Although new research tools increase productivity, their costs place extra burden on grant budgets, threatening to decrease the number of grants that can be supported. The increasing complexity of research projects demands that researchers work in an interdisciplinary team environment, rather than in isolated laboratories with occasional collaborators. NCI is striving to ensure that the resources needed for maximum productivity are widely available and that the support mechanisms facilitate, rather than hinder, the kind of research that can and should be done.
Balancing Research Opportunities and Costs
NCI has seen an enormous increase in the funding needed to allow scientists to fully exploit new technologies and approaches to conducting research. In Fiscal Year 2003, for example, the number of applications submitted to NCI increased by 9 percent, and the total NCI spending on research projects was nearly 8 percent higher than the year before. This cost increase reflects a larger number of total active awards as well as some growth in the average cost of awards.
While we expect this trend to moderate, we must balance the growing number of research opportunities with the rising costs of research. Reviewer assessments of research applications consistently identify the top 35 percent to 40 percent of grants as highly meritorious; the proportion actually funded (the success rate) has averaged 26 percent in recent years. To maintain this success rate, NCI carefully reviews individually approved grant applications for programmatic efficiencies, reducing the cost of a grant by an average of 10 percent. In addition to leveraging our Federal dollars, we must ask researchers to complement this funding from other sources as much as possible.
For the next generation of scientists to choose to enter cancer research, they must perceive opportunities for discovery with the potential to change our world. A sufficient infusion of resources and funding into investigator-initiated research will help to ensure that science students, as well as current researchers, undertake cancer research.
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NCI has sought to support and foster investigator-initiated research through a variety of policy decisions and flexible funding options.
Identifying and Supporting High-Priority Research
NCI takes extra steps to identify and support high-priority research by:
- Seeking out and supporting compelling research proposals with exceptions funding, particularly projects that employ dramatically new or unconventional approaches to understanding cancer.
- Giving special consideration to proposals responsive to high-priority research areas identified by NCI advisory groups, NCI Program Announcements of priority research areas, and recommendations from Progress Review Groups (PRGs) for research related to specific cancers.
We are also exploring better ways to define and promote the exploration of uncharted areas of research and to give them heightened consideration when reviewing grant applications.
Maximizing the Ability to Start New Projects and Collaborations
NCI maximizes the pace of discovery by providing a broad range of flexible funding options and promoting collaborations and resource sharing wherever possible. NCI is:
- Providing opportunities for collaborative study through awards such as program project grants (P01s) and cooperative agreements, in addition to the traditional research project grants (R01s) that make up the bulk of NCI's research portfolio.
- Providing seed funds for promising research. In Fiscal Year 2002, the number of small (R03) and exploratory/developmental (R21, R33) grants awarded increased more than 17 percent over the previous year.
- Enabling investigators to take advantage of unanticipated opportunities or to pursue interdisciplinary collaborations with administrative supplement funds. For example, through NCI's Activities to Promote Research Collaborations Program, grantees request funding for collaborations that will pursue novel, unforeseen opportunities and embrace resource sharing; develop new technologies; or organize cross-disciplinary meetings or workshops.
- Promoting collaborative studies and sharing of resources through innovative networks and consortia.
Enabling Research Across the Discovery-Development-Delivery Continuum
The undirected nature of investigator-initiated research requires grant mechanisms with substantial flexibility. Investigators use this flexibility to carry out development projects, all the way to and through Phase III clinical trials. See, Investigator-Initiated Research in Bone Marrow Transplantation Spans the Discovery-Development-Delivery Continuum. While researchers supported by investigator-initiated grants do not have immediate access to specialized resources provided by NCI under such targeted mechanisms as the Cooperative Group clinical trials program or SPOREs, informal alliances are encouraged by NCI staff and can be particularly beneficial for research carried out at NCI-supported Cancer Centers.
Training Scientists for Cancer Research
By providing salary support on research grants, investigator-initiated research is now the single largest training support mechanism for scientists. Training programs are critical, but have not expanded as rapidly as other grant mechanisms. To compensate, trainees are increasingly supported directly on grant budgets. In addition, the special attention accorded to research grants to new investigators eases their transition to independent research careers.
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| 1. | Accelerate the pace of discovery through increased funding for, and greater numbers of, competing research grants. | |
- Move research projects toward funding at the full levels recommended by peer reviewers.
- Fund, at a minimum, 35 percent of competing applications, with the following areas of emphasis: (1) the highest scientific merit; (2) a less certain probability of success, but potential to yield greater reward if they do succeed; (3) unconventional approaches but unique promise; (4) a focus on areas of extraordinary need in specific fields of investigation or model systems; and/or (5) the involvement of new investigators.
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| 2. | Facilitate rapid movement from discovery to development to delivery by using established mechanisms and creating novel special awards to encourage transdisciplinary and collaborative research. | |
- Expand supplemental funding for grants to promote new interdisciplinary collaborations for bringing together basic, clinical, and population scientists, such as those fostered by NCI's Activities to Promote Research Collaborations Program.
- Expand researcher access to central resources, such as databases, tissue banks, and animal models, by using funding supplements; centers, networks, and consortia; and cooperative resource programs.
- Expand researcher access to: (1) technologies that promote interdisciplinary research and collaborations, and (2) the expertise needed to move discoveries to application.
- Develop and make available information technology tools to foster and enhance interdisciplinary communication and collaboration.
- Expand the funding for collaborative research awards, such as program project grants and cooperative agreements, for consortia that facilitate translational research.
- Encourage more patient- and population-based research by expanding the use of exploratory grants.
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| 3. | Encourage investigators from a variety of scientific backgrounds to commit to careers in cancer research and to propose more innovative and higher-reward projects. | |
- Continue to allocate the first 80 percent to 90 percent of available funds for research project grants through the well-established peer review selection process, while ensuring that proposals from new investigators are also funded at a rate comparable to those of more established investigators, utilizing exceptions as necessary.
- Use a special administrative evaluation process to fund particularly innovative and potentially high-reward projects.
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| 4. | Encourage investigation in priority areas identified by advisory committees, NCI staff, Progress Review Groups (PRGs), and other groups, through regular and special award mechanisms. Leverage resources for these efforts through collaborative initiatives. | |
- Monitor investigator-initiated research to assess whether these projects alone are meeting programmatic objectives, such as those identified in specific disease areas.
- Set aside 10 percent to 15 percent of funds for Requests for Applications in specifically targeted areas of need.
- Support Program Announcements and investigator-initiated projects that target identified gaps and/or emerging opportunities (e.g., those identified by the PRGs and other priority setting and strategic planning activities).
- Enhance coordination within and among initiatives, and increase management and support commensurate with the growth of the portfolio.
- Encourage outreach to establish public-private partnerships and to leverage current NCI-funded activities with new, complementary, non-NCI sources of support, through supplemental awards.
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| Management and Support | $0.80 M |
| Total | $123.50 M |
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Investigator-initiated research is the engine of scientific discovery. It is also much more. Bone-marrow transplantation research, traditionally carried out under investigator-initiated program projects and traditional (R01) research grants, is an excellent example of cancer intervention research that spans the discovery-development-delivery continuum.
Over the past 15 years, a number of outstanding research groups have produced a quiet revolution in this field.
- In cancer therapy, bone marrow (or peripheral stem cell) transplantation was originally viewed largely as a supportive therapy that would allow the use of larger, more effective doses of chemotherapy and radiation. It is now clear that this conception understates the potential benefits of this therapeutic intervention.
- In transplants from related donors, where transplantation has been most effective in leukemias and lymphomas, much of the benefit derives from an immune response of donor white blood cells against residual tumor cells. This recognition has led to new transplant strategies, including the use of donor leukocyte (white blood cell) infusions for the treatment of relapse. Preparative regimens for both donors and recipients have been modified to maximize the immune-mediated benefit, improving efficacy while greatly reducing the toxicity in the recipient. As a result:
- The treatment is now available to older patients, extending the number of people who can benefit.
- The focus on immune cell reactivity to cancer has provided important new directions for pursuit in immunotherapeutic strategies outside the transplant setting.
Ultimately, all research progress stems from the creativity and drive of the cancer research community. NCI maintains a balanced portfolio of diverse support mechanisms to maximize the progress achieved through a remarkably wide range of investigational approaches. Within this portfolio, investigator-initiated research remains critical not only to discovery, but also to the development and delivery of cancer interventions.
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