DoD Rare Cancers, Idea Development Award

The FY24 RCRP Idea Development Award promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports research supported by preliminary data that could lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from rare cancers. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.

Preliminary data with disease-specific rationale (may include correlative studies to ongoing clinical research) to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study.

Key elements of the Idea Development Award are as follows:

Impact: Research that has high potential impact may lead to major advancements and greatly improve outcomes for people with rare cancers.

Research Idea: Although the proposed research must have direct relevance to rare cancers, the required preliminary data, which may include unpublished results from the laboratory of the Principal Investigator (PI), research team, or collaborators named on the application, or may be from outside the rare cancers research field. Research should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.

The application should clearly and explicitly articulate the project's potential impact on rare cancers. Applications that demonstrate exceptional scientific merit but lack high potential impact do not meet the intent of the Idea Development Award.

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.

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

CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological

DOD FY24 Rare Cancers Idea Development Award 5

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.

Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

Clinical trials are not allowed. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.