Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Burzie C Baker III Grantor

Description:

The FY24 RCRP RCDA supports the development of clinical or preclinical data sets and research resources that advance the field of rare cancers research and ultimately improve outcomes for individuals with rare cancers. Major gaps in patient care of rare cancers include lack of communication and dissemination strategies for rare cancers research and clinical findings within communities; lack of therapeutics and mechanistic studies to inform treatment development; lack of research and clinical resources, including patient tissues, cell, and tumor models; and lack of infrastructure for sharing data and other resources.

The intent of this funding opportunity is to develop research platforms that can share resources and knowledge pertaining to available preclinical or clinical research models, molecular pathways, and therapeutic approaches to facilitate collaboration and information sharing among stakeholders such as researchers, patients, caregivers, clinicians, and other members of the rare cancers community.

Clinical or preclinical datasets should strive to integrate or develop the following research resources. This list is not all-inclusive:

• Building and sharing rare tumor biospecimen repository with clinical annotation

• Databases/banks for centralizing and sharing data for patient registries that can be accessed globally

• Centralizing and sharing research models and molecular data related to genomics/ transcriptomics/immune profiling/proteomics/metabolomics/methylomics/bioinformatics

• Generating a data/reagent/model exchange program where researchers can list resources that they are willing to share and are tagged with indications that may be relevant

• Platform to enable or leverage longitudinal studies of disease natural history and treatment response

• Development of novel methods and systems for collection, sharing, and analysis of data or biospecimens

Applicants should include a well-formulated project design based on a strong scientific rationale and clearly articulate how the proposed resource platform or community development addresses an unmet need in rare cancers research. Applicants should explain the advantage of their approach to developing resources or community versus standard methodologies, techniques, or scopes. A clear plan for collaboration and data sharing needs to be demonstrated. It is critical to demonstrate how the outcome of the proposed project can benefit type(s) or sub-type(s) of rare cancers. It is encouraged for the research platform/resource to have an effect on multiple types or sub-types of rare cancers.

Key Elements of the Resource and Community Development Award are as follows:

• Impact: Outcomes of the RCDA must have potential for major impact on an unmet need in rare cancers research. A resource, as developed in the proposed research, should aim for

DOD FY24 Rare Cancers Resource and Community Development Award 5

long-term anticipated advantages toward greatly improving outcomes for people with rare cancers.

• Patient Advocate Partnership: Applications to the RCDA funding opportunity are required to include patient advocates who are involved with patient advocacy organization(s). The research team must include at least two rare cancers patient advocates who will be early and integral partners throughout the planning and implementation of the research project. Patient advocates should be involved in the development of the research question, project design, oversight, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, and not limited to attending seminars and semi-annual meetings. The patient advocates must be individuals who have been directly impacted by a rare cancer either by being diagnosed themselves or as a caretaker/family member of a patient, and they should be active in a cancer advocacy organization or within a support group focused on their rare cancer. Their role should be focused on providing objective input on the research and its potential impact for individuals with or at risk for a rare cancer. The patient advocates should have a high level of understanding of current rare cancers research.

• Preliminary Data: Due to the developmental nature of this award, preliminary data are not required but may be included, if available, to address the feasibility of the resource to be developed. Whether or not preliminary data are included, applications must apply solid scientific rationale and logical reasoning based on existing knowledge to the development of the proposed product.

• Clinical Research: Research involving human subject use is permitted under this mechanism but is restricted to studies without clinical trials. Clinical trials will not be supported. Applications focused on clinical research should demonstrate how the study will leverage clinical information to address knowledge gaps in the development of platforms that can be utilized for sharing data and tissue, the development of clinical annotation datasets, process development, and/or infrastructure development.

• Applied Research: Preclinical studies utilizing or creating animal models to further research into rare cancers may be supported by this funding opportunity. The RCDA is intended to support projects that will have the potential to move beyond the realm of basic research, with results that may impact clinical research or patient outcomes.

• Community Building: A plan describing how the rare cancers stakeholder community will be built/enhanced and the community’s involvement with developing the resource platform is required. It is also important to justify how the community is essential for the development and sustainment of the resource platform.

• Dissemination: A Dissemination Plan is required. The plan should describe the means by which the fully developed resource platform will be made easily available to the scientific and/or clinical community. Dissemination of resource platform will play a major role by not only educating the rare cancer community about the recent progress, but also help to develop an informational network.

DOD FY24 Rare Cancers Resource and Community Development Award 6

• Sustainment: A plan that outlines the sustainability of the resource in the future is required. The plan should detail the types of rare cancers that are less studied in the collaborations and the resources to be gathered, annotated, and sustained. Additional expansion and feasibility plans should be included. It is important to demonstrate how the outcomes of the current award will be continued and eventually will help the rare care cancer community, beyond the award period.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 RCRP priorities.

Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women's health.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org