OpportunityTitle: DoD Joint Program Committee/Military Infectious Diseases Clinical Study Award
Description: The FY17 JPC-2/MIDRP CSA is intended to support military relevant early phase clinical trials and in vitro diagnostic medical device clinical investigations with the potential to have a major impact on the prevention, screening, diagnosis, and/or treatment of combat-related or trauma-induced wound infections. Early phase clinical trials and medical device testing supported by this award range from proof of concept (i.e., first in human or Phase 0) trials through Phase II clinical trials, as well as Class I, II, or III medical device testing. Phase III trials for FDA licensure of drugs or definitive testing for device or assay clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human subjects or human clinical samples to accelerate their translation to clinical utility. Therefore, proposed projects should be focused on testing and translating investigational interventions or devices already proven in relevant definitive animal models and moving those interventions or devices into advanced clinical development. Funding from this Program Announcement/Funding Opportunity must support a clinical trial or medical device testing and may not be used for preclinical research studies. For this Program Announcement/Funding Opportunity, the term &#8220;human subjects&#8221; refers to individuals who will be recruited for or who will participate in the proposed clinical trial. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. A medical device testing is defined as clinical investigations of in vitro diagnostic (IVD) devices involving human specimens. IVD devices include assays, reagents, instruments, and systems for diagnostic or prognostic determination of the state of health, in order to prevent, screen, mitigate, and/or treat combat-related or trauma-induced wound infections and their sequelae. Principal Investigators (PIs) seeking support for preclinical research studies should apply to the FY17 JPC-2/MIDRP Applied Research Award (Funding Opportunity Number: W81XWH-17-DMRDP-MID-ARA). All of the following are important aspects of FY17 JPC-2/MIDRP CSA application submission: &#8226; Include only one early-phase clinical trial (Phases 0, I, and II) or IVD diagnostic medical device testing (Classes I, II, and III) that begins no later than 12 months after the award date. &#8226; Inclusion of preliminary data relevant to the proposed research project is required. Any unpublished preliminary data should originate from the laboratory of the PI(s), collaborator(s), or subawardee(s) named in the application. &#8226; Demonstrate sound scientific rationale established through logical reasoning and critical review and analysis of the literature. &#8226; Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed. Quality should be commensurate with U.S. Food and Drug Administration (FDA) manufacturing standards applicable to the type and phase of product being developed (i.e., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Quality System Regulation). &#8226; Demonstrate and document availability of and access to a suitable human subject population and/or resources that will support a meaningful outcome for the clinical trial/testing. &#8226; If applicable, include a discussion of how accrual goals will be achieved and how standards of care may impact the study population. &#8226; Describe appropriate and clearly defined endpoints for the proposed clinical trial/ testing. &#8226; Include a clearly articulated statistical analysis plan, as well as appropriate statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. &#8226; Discuss the potential impact of the study results on prevention, screening, diagnosis, and/or treatment of combat-related or trauma-induced wound infections. &#8226; If applicable, include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. &#8226; For studies determined to be greater than minimal risk to human subjects by the local IRB of record, an independent research monitor with expertise consistent with the nature of risk(s) must be identified within the research protocol. &#8226; Demonstrate institutional support and access to institutional resources for all participating organizations. &#8226; Include a Transition Plan that describes a clear path to further develop the research results, including a plan and potential funding source for the next phase of development after the successful completion of the proposed study. Partnering PI Option: The FY17 JPC-2/MIDRP CSA includes a Partnering PI Option structured to accommodate up to three PIs who will each receive a separate award. One partner is identified as the Initiating PI and the other partner(s) as the Partnering PI(s). All partners should collaborate in the development and submission of the proposed research project. It should be clear that each partner has a significant level of intellectual input and brings complementary strengths to the project. Multidisciplinary and multi-organizational projects are allowed. If multi-organizational, all participating organizations must be willing to resolve potential intellectual and material property issues and remove any barriers that might interfere with successful completion of the research. Multi-Institutional Clinical Trials/Testing: If the proposed research is multi-institutional, plans for communication and data transfer among the collaborating institutions, as well as how data, specimens, imaging products, and/or other materials obtained during the study will be handled, should be included in the appropriate sections of the application(s). A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials/testing.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;301-682-5507