DoD Prostate Cancer, Exploration - Hypothesis Development Award
Agency: Dept. of the Army -- USAMRAA
Posted: 2024-05-01 | Closing date: 2024-07-12
Estimated total program funding: 3600000
Expected number of awards: 15
Cost sharing or matching requirement: No

The FY24 PCRP Exploration – Hypothesis Development Award supports the exploration of highly innovative, untested, potentially high-gain concepts, theories, paradigms, and/or methods that address an important problem relevant to one or more of the FY24 PCRP Overarching Challenges. This award is designed to provide investigators the opportunity to pursue serendipitous observations that may reveal entirely new avenues for investigation. Results of studies conducted through this award may provide the scientific premise upon which a new hypothesis can be based or initial proof of principle of an innovative hypothesis, laying the groundwork for future avenues of scientific investigation. Presentation of preliminary data is inconsistent with the intent of this award mechanism and is therefore strongly discouraged. However, logical reasoning and a sound scientific rationale for the proposed work must be described. Reviewers will be blinded to the identity of the Principal Investigator (PI), collaborator(s), and their organization(s). Refer to Section II.D.2.b.i, Full Application Submission Type, for more information. New for FY24: Clinical research is allowed. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes: (1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies. (2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. (3) Outcomes research and health services research that do not fit under the definition of clinical trial. Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule. 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. 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, the 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 PCRP priorities. 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. 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. 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. The funding instrument for awards made under the program announcement will be grants (31 USC 6304). The anticipated direct costs budgeted for the entire period of performance for an FY24 Exploration – Hypothesis Development Award should not exceed $150,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. Awards supported with FY24 funds will be made no later than September 30, 2025. The CDMRP expects to allot approximately $3.60M to fund approximately 15 Exploration – Hypothesis Development Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030. Research Involving Animals: All research funded by the FY24 PCRP Exploration-Hypothesis Development Award involving new and ongoing research with animals must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO; previously the Human Research Protection Office), Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions for additional information.