On behalf of Toby T. Hecht, Ph.D. Associate Director, Translational Research Program, DCTD, NCI and
Robert Yarchoan, M.D., Director, Office of HIV and AIDS Malignancy, NCI
To the HIV Malignancy Community:
During a panel discussion at the International Conference on Malignancies in HIV/AIDS (ICMH) this October, it was noted that a barrier to research in HIV/AIDS malignancies is the separation between the basic and clinical researchers and the difficulty in funding combined projects that span basic, translational, and clinical research. We wanted to make you aware of one such mechanism that exists right now: the NCI Specialized Programs of Research Excellence (SPORE) program. This program was originally established to fund research on cancer in one organ-site but has since been expanded to allow funding of cancers with a common theme, such as HIV-associated malignancies (PWH). Below is some relevant information about the SPORE program.
Background:
In 1991, Congress, at the urging of cancer patients advocates, requested that the NCI to establish the SPORE program—a team-science, multidisciplinary program of cancer translational research—with $20 million to bridge the gap between research in basic cancer biology and clinical studies in the four most prevalent organ-site malignancies in the United States: breast, prostate, lung, and GI. The program was initiated in 1992 and over the years grew to accept applications in other specified organ sites, followed in later years by a decision to include applications in all organ sites and groups of highly related cancers, such as sarcomas, neuroendocrine tumors, and head & neck cancers. The budget of the SPORE program is now ~ $110 million per year and currently sponsors 56 grants.
In the last 7 years, the SPORE program has encouraged the submission of “thematic” applications. Examples of this type of grant are cancer health disparities, pediatric cancers, virally related cancers (e.g., HPV, etc.), and cancers that are connected because of abnormalities in their signaling pathways. At this time, the Translational Research Program (TRP), which manages the SPORE program, has about 9% of its portfolio in thematic SPOREs. These include hyperactive RAS in the context of NF1 mutations, epigenetics, radiation sensitization, and cancer health disparities.
Aspirational Goal of the SPORE Program and its Importance:
Although the SPORE program has had many awarded grants in sarcoma, non-Hodgkin lymphoma, and cervical cancer, none of these have addressed the important research area of HIV/AIDS-related cancers and cancers arising in PWH. In fact, the program has never received applications in these areas. This is a missed opportunity for the health of the American people and the world at large, especially since 1.2 million people in the U.S. and about 40 million worldwide (including 1.4 million children) are estimated to be living with HIV and may develop cancer during their lifetime. SPOREs could be an important research mechanism for translating findings in the laboratory to testing in clinical trials for the benefit of cancer patients with HIV/AIDS.
SPOREs
The SPORE program is the premier translational research initiative for cancer in the NCI. In this program, the definition of translational research is as follows: “Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer.”
The program differs from the more well-known Program Project Grant (P01) mechanism in several ways. A full description of the program and its requirements can be found in the current SPORE Program Announcement (PAR-23-284). A summary of the key requirements is as follows:
- A minimum of 3 projects, each of which must reach a human endpoint during the project period. Projects do not have to interact with each other as do P01 grants.
- A team science approach with each project led by both a basic scientist and either a clinical or applied (e.g., epidemiologist) scientist.
- Requires scientific collaboration outside the SPORE itself.
- Must contain an Administrative and Biospecimen shared resource Core (with other Cores being optional).
- Includes Developmental Research Program (DRP) for short pilot or high risk/high payoff studies and a Career Enhancement Program (CEP) for investigators who which to refocus their careers to translational research.
- At least one SPORE-initiated clinical trial/SPORE must be proposed for activation during the project period.
In addition:
- SPOREs can make use of a flexibility option to realign resources to discontinue a project that is not meeting its translational goals and substitute a more promising project with only the approval of the TRP Program Officer and the SPORE’s External Advisory Board.
- Although the SPORE must be based in a U.S. institution, foreign components are permitted.
- Each SPORE application may request up to $1.4 million direct costs per year.
We believe that the SPORE program would be a fitting mechanism for the study of HIV/AIDS-related malignancies, and we encourage you to consider applying to the program. We also encourage you to contact Dr. Igor Kuzmin (kuzmini@mail.nih.gov) in the TRP about a pre-application consultation about 4 months prior to submission to make sure your application is responsive to the SPORE Program Announcement.
Toby T. Hecht, Ph.D. Associate Director, Translational Research Program, DCTD, NCI and Robert Yarchoan, M.D., Director, Office of HIV and AIDS Malignancy, NCI