DoD DMRDP Military Infectious Diseases Clinical Trial Award

archived

Overview: The FY14 DMRDP MID-CTA is intended to support early phase clinical trials/ testing with the potential to have a major impact on treatment of combat-related or trauma-induced wound infections. These studies must be responsive to the health care needs of military Service Members and Veterans; however, the use of military populations in the clinical trial/ testing is not a requirement. Proposed projects should be designed to demonstrate the safety and efficacy of novel therapies and diagnostics in human patients suffering from serious, debilitating combat-related or trauma-related wound infections. The purpose of such demonstrations is to accelerate translation of greater medical capabilities to patients; this can 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 trials/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. Projects of interest are those 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 award mechanism must support a clinical trial/testing and cannot be used for preclinical research studies. A clinical trial/testing 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. For this Program Announcement/Funding Opportunity the term “device” includes diagnostics (e.g., in vivo, in vitro, and/or biomarkers). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. For this Program Announcement/Funding Opportunity the term “human subjects” refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information onclinical trials and phase/class of study, a Human Subject Resource Document is provided athttps://cdmrp.org/Program_Announcements_and_Forms/.If the proposed trial involves the use of a drug that has not been approved by the FDA for its investigational use, then an Investigational New Drug (IND) application may be required. If the proposed study involves an investigational device that has not been approved or cleared by the FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If the documented status of the IND or IDE has not been obtained within 6 months of the award date, the award may be terminated for failure to comply with a material provision of the award.All of the following are important aspects of FY14 DMRDP MID-CTA application submission. The application should:• Include a clinical trial that begins no later than 12 months after the award date, if a clinical trial is proposed.• Include preliminary data relevant to the proposed research project. Preliminary data relevant to the proposed research are required; any unpublished preliminary data originating from the laboratory of the Principal Investigator (PI), collaborator(s), or subawardee(s) named on this application should be included.• Be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature as documented in the application.• Demonstrate and document availability of and access to the drug/compound, device, and/or other materials needed.• Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study.• Include a discussion of how accrual goals will be achieved, and how standards of care may impact the study population.• Describe appropriate and clearly defined endpoints for the proposed clinical trial/testing.• 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.• Discuss the potential impact of the study results on prevention and/or treatment of combat-related or trauma-induced wound infections.• Include a study coordinator(s) who will guide the clinical trial 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.• Demonstrate institutional support and access to institutional resources• Include a Transition Plan that describes a clear path to further develop the trial product and how the project will continue to the next level of development after the end of the award period of performance.

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