Specialized Programs of Research Excellence (SPORE) in Human Cancer (P50 Clinical Trial Required)

Specialized Programs of Research Excellence (SPORE) in Human Cancer (P50 Clinical Trial Required) is sponsored by National Cancer Institute (NCI). This funding opportunity invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPORE).

PAR-23-284: Specialized Programs of Research Excellence (SPOREs) in Human Cancers for Years 2024, 2025, and 2026 (P50 Clinical Trial Required) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) National Institute of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title Specialized Programs of Research Excellence (SPOREs) in Human Cancers for Years 2024, 2025, and 2026 (P50 Clinical Trial Required) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 October 17, 2023 - Notice of Change to Other Attachments in PAR-23-284 "Specialized Programs of Research Excellence (SPOREs) in Human Cancers for Years 2024, 2025, and 2026 (P50 Clinical Trial Required). See Notice NOT-CA-23-097 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPORE).

Based on the research proposed, applications may be jointly funded with the National Institute of Dental and Craniofacial Research (NIDCR). The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a highly related group of cancers.

For the purpose of this NOFO, a group of highly related cancers are those that are derived from the same organ system, such as gastrointestinal, neuroendocrine, head and neck, and other cancers. Other programmatically appropriate groups of cancers may include those centered around a common biological mechanism critical for promoting tumorigenesis and/or cancer progression in organ sites that belong to different organ systems.

For example, a SPORE may focus on cancers caused by the same infectious agent or cancers promoted and sustained by dysregulation of a common signaling pathway. In addition, a SPORE may focus on cross-cutting themes such as pediatric cancers or cancer health disparities.

The research supported through this program must be translational and must stem from research on human biology using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date.

The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPORE). Based on the research proposed, applications may be jointly funded with the National Institute of Dental and Craniofacial Research (NIDCR).

The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a related group of cancers. For this NOFO a group of highly related cancers are those that are derived from the same organ system, such as gastrointestinal, neuroendocrine, head and neck, and other cancers.

Other programmatically appropriate groups of cancers may include those centered around a common biological mechanism critical for promoting tumorigenesis and/or cancer progression in organ sites that belong to different organ systems. For example, a SPORE may focus on cancers caused by the same infectious agent or cancers sustained and promoted by the dysregulation of a common signaling pathway.

In addition, a SPORE may focus on cross-cutting themes such as pediatric cancers or cancer health disparities. The research supported through this program must be translational and must stem from research on human biology using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant.

Key De fi nitions in the Context of this NOFO 1. Translational Research: 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 term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biological agents, and/or other methodologies applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. SPORE translational research projects may involve the use of any cellular, molecular, structural, biochemical, and/or genetic experimental approaches.

By this definition, SPORE projects are permitted to move not only in the forward direction, toward clinical trials and studies in areas of prevention, early detection, treatment, development of biomarkers, and population science, but also in the reverse direction, using human biospecimens, often from clinical trials, to study new phenomena, to optimize previous findings, or to develop new hypotheses based on results from human studies.

2. Early detection, Prevention, or Population Science (EPPS) Projects: Early Detection: An early detection project is one that is either focused on the discovery of early detection biomarkers and/or on the development of an assay that determines the presence of precancerous lesions or early invasive cancer.

For either type of project, there would need to be an already established or experimental subsequent intervention for treating the detected lesions.

Qualified projects include early detection of a new primary tumor that appears as a result of a cancer field effect (which is defined as a process occurring in an area of epithelium surrounding a primary tumor that contains genetically transformed, but histologically normal cells that are predisposed, perhaps because of a carcinogenic insult, to subsequent tumor development).

Testing for metastases or recurrence of the primary tumor is not early detection. Screening, the application of the assay as a standard medical procedure in the general population or high-risk populations, is not considered to be the same as early detection for the purposes of this definition even though these terms are sometimes used interchangeably.

Prevention: A prevention project investigates a medical, surgical, or lifestyle intervention that has as its aim the reduction of cancer incidence in individuals at risk. A project that addresses the prevention of a second primary tumor is also appropriate. A project that addresses the prevention of cancer recurrence is not acceptable as an EPPS project.

A therapeutic vaccine in a no-evidence-of-disease state would not be considered secondary prevention, but rather a therapeutic intervention (i.e., adjuvant therapy). However, a project that develops a vaccine that targets "at-risk" lesions (e.g., pancreatic cysts, Barrett's esophagus, or ductal carcinoma in situ (DCIS)) is appropriate.

Specific aims of the qualified prevention projects should include implementation and/or analysis of a proposed investigational preventative intervention in human subjects.

Population Science: Population science aims to understand the causes and distribution of cancer in a variety of populations, supports the development and delivery of effective interventions to reduce cancer risk, mortality, and morbidity, as well as the social cost of cancer, and monitors and explains cancer trends in all segments of the population.

A population science project specifically in the SPORE may focus on study participants selected from sampling frames drawn from the general population, individuals at risk for cancer, or cancer patients.

Unlike clinical trials with their specific inclusion criteria, population science studies should be sufficiently representational to allow for substantial external validity, i.e., generalized inferences to the target populations in the studies.

Likewise, population science studies that focus on biomarker discovery and/or validation may not draw on specimens from convenience samples, such as a case series of highly selected patients, but instead must be drawn from a sampling frame that represents the target population under study and must be based on samples that allow for inferences to the target populations.

A SPORE Population Science project may draw upon already existing population science resources or may develop new cohorts to examine a specific translational research question in collaboration with basic, clinical, and population science investigators.

An example of a project fitting the definition would be a study to validate the potential for biomarkers to predict the progression of DCIS to invasive cancer that uses a sampling frame of women undergoing routine breast cancer screening drawn from clinical practice.

However, a project focused on biomarker discovery of DCIS that is based on tissue samples drawn from a case series of patients (particularly as part of a single clinical study) and who are not representative of the target population for breast cancer screening would not fit the definition of population science in a SPORE project. 3.

Cancer Health Disparities and Minority Health (CHD-MH) Projects: Cancer health disparities refer to health differences that adversely affect specific populations, based on one or more of the following health outcomes listed below.

Higher incidence and/or prevalence and earlier onset of cancer; Higher prevalence of risk factors, unhealthy behaviors, or clinical measures in the causal pathway of a cancer outcome; Higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized metrics; Premature and/or excessive mortality from cancer; and Greater global burden of cancer using standardized metrics.

Minority health research is the scientific investigation of distinctive health characteristics and attributes of minority racial and/or ethnic groups who are usually underrepresented in biomedical research to understand health outcomes in these populations. NIH defines health disparity populations as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, and underserved rural populations.

SPORE research in CHD-MH projects should focus on 1) the investigation of health outcomes and/or disparities in health outcomes and 2) the development of novel-cancer relevant interventions in underserved populations with cancer or at risk for cancer. Proposed CHD-MH projects would require a reference or comparator group to assess disparities in cancer outcomes.

However, the identified reference group would be based on the scientific rationale or question proposed and is not by definition required to be non-Hispanic White.

Examples of SPORE projects focusing on cancer patients or individuals at risk for cancer that would qualify for the CHD-MH designation include, but are not limited to, the following: Discovery, validation, and assessment of how various determinants of health intersect with the biology of cancer to promote cancer in underserved populations, including geographical location, environment, culture, occupation, access to care, genetic ancestry, socioeconomic status, race, and ethnicity.

Characterization of the biological impact of social determinants of health and identifying specific biological pathways that might be targeted by clinical or public health interventions. Hypothesis generating studies characterizing risk factor prevalence or biological differences in underserved populations.

Investigating the role of determinants of health and comorbidities on toxicity to therapeutic interventions in underserved populations. 4. Scienti fi c Collaborations: Horizontal Collaboration: Collaboration with others outside the SPORE grant to complete the research aims and/or goals of a SPORE project.

These collaborations may be done in the laboratory, at the clinical trial stage, or as a part of a population science study. Examples of these collaborations include projects with other SPOREs or the use of industry-provided agents. Interactions between Projects and Cores within a SPORE grant do not meet the definition of Horizontal Collaboration.

Vertical Collaboration: Collaboration with an entity outside the SPORE grant that extends SPORE translational research beyond the specific aims of projects along the translational continuum (e.g., from discovery to pre-clinical development, to Phase I trials or studies, to later phase studies, and possibly to a final hand-off to a commercial company). A clinical research study as defined by NIH ( https://grants. nih.

gov/policy/clinical-trials/definition. htm ). A population science study is acceptable if it meets this clinical trial definition.

The following are considered named key personnel: SPORE PD/PI(s), project co-leaders, Core directors, CEP director(s), DRP director(s), and SPORE administrator(s).

General Description of SPOREs In most cases, individual SPORE applications are expected to focus on a particular organ-specific cancer, such as breast or prostate, or a group of related cancers that belong to a common organ system, for example, gastrointestinal cancers, neuroendocrine cancers, head and neck cancers, or sarcoma.

Alternatively, some SPOREs may focus on cancers related by common biological pathway mutations/alterations or on cancers related by other cross-cutting themes, such as pediatric cancers, virus-related cancers, or cancer health disparities. In addition, all SPOREs include the following common features: 1.

Translational Research Focus All SPOREs must be focused on translational research that meets the definition provided above (see key definitions section). SPOREs are dedicated to capitalizing on research opportunities that have the potential to change the current paradigm in the prevention, detection, diagnosis, and/or treatment of human cancer.

SPORE projects may include basic science objectives if those objectives are relevant to human cancer and will lead to a human endpoint within the 5-year project period of the grant. 2.

Flexibility to Change Research Direction/Team Approach The flexibility of the SPORE program was established for the PD(s)/PI(s) to terminate research projects that accomplished translational goals earlier than anticipated or that demonstrate little or no translational progress, and to replace them with new projects that have translational potential.

As a result of this flexibility, the team of scientists that participate in SPORE projects may or may not remain the same, and the roles of co-leaders on projects may change throughout the course of the funding period. The flexibility option may not be used to add full scientific projects over and above the number of projects that were peer-reviewed, even if no new funds are requested.

The PD(s)/PI(s) of the SPORE are expected to make decisions about the continuation or discontinuation of projects in consultation with internal and external advisors, as well as with other lead investigators on the SPORE.

The flexibility option is available only after the first year of the funding period for SPOREs with three or more scientific research projects; a new project cannot be proposed for one that has overlap with an awarded or soon-to-be awarded U.S. Public Health Service (PHS) grant. 3.

Specialized Research Infrastructure SPOREs are expected to establish the critical research infrastructure needed to sustain the translational research projects proposed within the SPORE. SPOREs must be able to facilitate the complex research objectives inherent in studying human cancer.

It is essential that robust mechanisms be in place for making shared resource data generated by the SPORE readily accessible to research and clinical investigators in the broader scientific community. SPOREs should support the establishment of translational research cores that fill broad institutional infrastructure gaps.

SPOREs also should utilize and augment existing cores within Cancer Centers and other institutional facilities wherever feasible. SPORE cores should not duplicate existing institutional cores or other resources. 4.

Fostering Translational Research Careers SPOREs provide a unique environment for translational research that can be used to prepare new scientists for careers in this evolving field or provide the opportunity for established scientists to re-orient their research careers toward translational research. 5.

Research Collaborations, Networks, and Consortia SPOREs are expected to identify the kinds of research questions that can only be accomplished through collaborations, networks, and consortia and take full advantage of SPORE's scientific expertise and infrastructure. 6.

Participation in NCI-Sponsored SPORE-related Meetings, Workshops, and other Activities SPORE Directors and other SPORE investigators should participate in NCI-sponsored meetings, workshops, and working groups to share expertise and research results with other translational research grantees.

The goals of these meetings may include the identification of consensus data standards, sharing of materials and data, assessing progress, and identification of new collaborative opportunities. Through this NOFO, the NCI invites applications for P50 Research Center Grants for SPOREs in organ-specific, groups of highly related cancers, or cancers driven by common activation pathways or cross-cutting themes.

Based on the research proposed, applications may be jointly funded with the National Institute of Dental and Craniofacial Research (NIDCR). This NOFO targets applicant institutions with a demonstrated ability to conduct translational research (see key definitions) in the prevention, early detection, diagnosis, and/or treatment of human cancer.

Applications focusing on novel cross-cutting themes are encouraged, including, but not limited to: targeting of commonly mutated oncogenes or reactivating tumor suppressor genes; cancers centered around a common biological mechanism; pediatric cancers; or cancer health disparities. Applicants are advised to consult with NCI staff members in the Translational Research Program (TRP) regarding the focus of their application.

All proposed SPORE projects must be translational. Every SPORE project must include both a laboratory component and a human endpoint that must be reached during the project period of the grant.

In each SPORE project, at least one of the following types of human endpoints should be proposed: Early phase clinical trials of new investigational drugs, biologics, experimental procedures, medical devices, or combinations; Early phase clinical trials of new combinations or new uses of Food and Drug Administration (FDA)-approved agents and devices; Discovery and development of biomarkers, only when measurements are made in human specimens, or directly in human subjects; Laboratory studies that begin with an observation in the clinic, for example development of therapeutic resistance, and use human specimens to generate new clinical hypotheses; Population, behavioral, or psychosocial studies, when these studies address and measure mechanistic aspects of the biology of the disease; Investigational New Drug (IND)-directed toxicology studies conducted following a pre-IND meeting with the FDA in which the plan proposed by the investigators is acceptable to the FDA.

Experiments using cell lines, xenografts, patient-derived xenografts (PDX), organoids, paired germline samples, or engineered tissues may be important to the translational studies proposed and are recommended but are not sufficient to meet the human endpoint requirement. All SPORE applications must include at least one project that proposes, as a specific aim, a SPORE investigator-initiated clinical trial.

The clinical trial can also serve as the required human endpoint for that proposed project. An IND-directed toxicology study can serve as a human endpoint, but it is not sufficient to satisfy the clinical trial requirement. Inherent in this process is the interdependence between investigators conducting basic and applied research.

Clinical and/or epidemiological research that does not include a wet laboratory or imaging component is not considered translational for the SPORE. Major Components of SPORE Applications Research projects may be conducted solely through the parent institution, or through collaborative associations that have been developed and/or are planned with other SPOREs and/or with other investigators in the biomedical research community.

All SPOREs should meet the following criteria: New SPORE Applications : A minimum of three projects, each with a human endpoint, must be proposed in new applications. At least one of the proposed projects must have a clinical trial. Renewal SPORE applications : Renewal applications have the option of submitting two projects, as opposed to the required minimum of three projects.

Under this option, the two proposed projects must be large-scale, collaborative, and multi-institutional, addressing the most important questions within the organ site(s) or cross-cutting cancer theme. The two projects must draw on the successful outcomes of projects funded in the previous grant cycle and expand the original scope of each. Therefore, a new project will not be considered for the optional two-project submission.

Each proposed project must meet the definition of translational research as described in the key definitions section. Investigators who are not certain about whether their project fits this definition are advised to consult with the Scientific/Research staff listed in Section VII. Agency Contacts.

Each proposed research project should be designed to test the relevance and/or potential importance of the research to human cancer within the project period of the grant. Projects containing basic research (e.g., employing animal models or cell lines) qualify as translational only if a human endpoint is included in the specific aims.

At least one SPORE project must propose, as a specific aim, a clinical trial that is SPORE-initiated and in which the trial protocol is developed by the SPORE investigators and the trial must be funded in part or in full by the SPORE. SPOREs are encouraged to represent a balance and variety of translational research objectives (e.g., early detection, prevention, diagnosis, and treatment).

SPOREs should describe a program-wide consent process that would inform patients about the: risks and rewards of participating in the clinical study of the SPORE program; and the possibility that some data may be made available to private sector collaborators that would enable the use of individual patient information in research that is not envisioned at the time of consent.

SPORE applications are encouraged to include the following: Patient, research and/or community advocates with a collective patient perspective. Early Detection, Prevention, or Population Science (EPPS; see key definitions section) projects as defined in Key Definitions above. Cancer Health Disparities and/or Minority Health (CHD-MH; see key definitions section) projects.

Research projects that bring together investigators from multiple institutions to facilitate the development of large-scale team-based projects. An Administrative Core is required.

This Core describes SPORE's organization and capabilities, including the organizational, administrative, scientific, and clinical trial management within the SPORE, and explains how coordination, communication, and varied perspectives will be achieved among the different projects and programs, Shared Resources Cores, and participating institutions at the overall program level. 3.

Shared Resources Cores SPORE applications are required to include a Biospecimen/Pathology Shared Resource Core and have the option to include other Shared Resources Cores that provide laboratory and/or clinical facilities, equipment, and/or services to be shared by one or more research projects and developmental programs. A Biostatistical Core is strongly advised.

Shared Resources Cores may include non hypothesis-driven research activities (e.g., technology development) provided that the research is designed to improve Core services. The Shared Resources Cores within the SPORE should not duplicate any shared resource facilities that are already available to the research group but may build upon these facilities for unique capabilities required by the SPORE. 4.

Developmental Research Program (DRP) Each SPORE must allocate a significant effort to support pilot projects that take maximum advantage of new research opportunities in the organ site, group of highly related cancers, or cross-cutting theme that is the focus of the SPORE. The pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE community.

High-risk/high-payoff pilot projects are especially encouraged. These pilot projects are not required to reach a human endpoint during the project period as do full projects. As a required component of a SPORE, a DRP must be maintained throughout the entire term of the grant.

The DRP should be structured in a way that the awards run in parallel with the current budget period. With the approval of the SPORE’s External Advisory Board and the assigned NCI Program Official, DRP studies may become full SPORE projects as part of the flexibility option if the DRP study has translational research potential within the SPORE and incorporates a human endpoint within one of the project aims. 5.

Career Enhancement Program (CEP) The SPORE must demonstrate a consistent and substantial commitment to a Career Enhancement Program (CEP) in translational research. As a required element of the SPORE, the CEP must be maintained throughout the entire term of the funding period. The CEP should be structured in a way that the awards run in parallel with the current budget period.

Funds from this program may be used to support junior faculty or established investigators who wish to enhance or refocus their careers on translational cancer research. CEP recipients are expected to interact with SPORE-associated translational research advisors to guide the project and monitor progress.

This program is not a training program and does not support pre- or post-doctoral fellows, irrespective of whether they are working in the pre-clinical or clinical domain . However, advanced post-doctoral or clinical fellows who provide a letter from an institution stating that the candidate will be joining its faculty within one year are eligible for this program.

Investigators supported by NCI career development awards (K series) may also be eligible for support through this program. Similar to DRP projects, CEP may become full projects as part of the flexibility option with the approval of the SPORE’s External Advisory Board and the assigned NCI Program Director. 6.

Scientific Collaboration Each SPORE must demonstrate a commitment to both horizontal and vertical collaboration (see key definitions section) in completing preclinical projects and moving promising results along the pathway of translational/clinical development.

Through the promotion of inter-SPORE research, SPOREs also conceive and initiate research that is further linked to other key programs of the NCI, NIH, and other government and non-government programs. Acceleration of therapeutic agent development or biomarker development is encouraged. However, not every project within a SPORE must involve collaboration.

Pre-application Communications with NCI Staff Each prospective SPORE applicant is advised to schedule a pre-application consultation with the assigned NCI staff.

The consultation should be scheduled at least 4 to 6 months in advance of the application due date and is intended to help the PD/PI (along with one or more of his/her intended co-investigators) understand the Program and its translational objectives, and discuss strategies for preparing a competitive application. NCI staff will clarify SPORE requirements, and current NCI budget allocations, and describe the peer-review process.

The NCI staff can also answer questions about the NCI-supported clinical trials and other collaborative resources that might be available beyond the funded activities of the SPORE as part of planned vertical collaborations. PDs/PIs of resubmission and renewal applications have also found it useful to schedule a pre-application discussion with NCI staff, as program and review policies may have changed since the previous submission.

Supplemental funding for SPOREs is rare and may be awarded only in unusual and compelling circumstances. Those recipients who wish to submit such an application are advised to speak first with their Program Officer at the NCI.

Non-Responsive Applications The following types of activities remain outside the scope of this NOFO and are non-responsive (non-responsive applications will not be reviewed): Applications lacking translational research focus on an organ-specific cancer, a group of highly related cancers, or cancers driven by common activation pathways or a cross-cutting theme.

Applications that do not include appropriate human endpoints, including at least one SPORE investigator-initiated clinical trial (as defined above). Applications that do not meet the Minimum Research Base requirement (as defined below).

Renewal applications proposing just two projects that are not large-scale, collaborative, and multi-institutional, addressing the most important questions within the organ site(s) or cross-cutting cancer theme. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Approximately six to ten SPORE awards per year are anticipated.

Applicants may request a maximum of $1,400,000 in direct costs/year, which excludes third-party indirect costs. Applications that include one or more qualified Early Detection, Prevention, or Population Science (qualified EPPS) project(s) may request up to an additional $120,000 in direct costs/year to support this project(s) and supporting cores, if appropriate.

Likewise, the inclusion of one or more Cancer Health Disparities/Minority Health (CHC-MH) projects would allow an additional $120,000 in direct costs/year to be requested for the project(s) and supporting cores, if appropriate. The maximum project