OpportunityTitle: DoD DMRDP JPC-8  Clinical and Rehabilitative Medicine
Description: The FY15 JPC-8/CRMRP ERI is intended to support Phase I, II, or pivotal clinical trial phase development projects focused on extremity regeneration. The focus is on bone and soft tissue reconstruction, limb and tissue salvage technologies, and regenerative medicine technologies for the treatment of trauma-induced damage. All clinical trials must be responsive to the health care needs of military Service members and Veterans, as well as the general public. All proposals/applications must specifically and clearly address the military relevance of the proposed research.Proposals/applications submitted to the FY15 JPC-8/CRMRP ERI must specifically address one or more of the Focus Areas listed below.&#8226; The treatment of soft tissue injury, specifically, nerve, muscle, and vascular injury to the extremities. The aim of these technologies is to: (a) maintain the structure and function of end organs distal to a nerve injury, (b) restore functional muscle tissue, and (c) restore vascular perfusion. Both innovative care solutions as well as innovative technologies that may better enable a definitive care solution to be delivered at some future time point, such as vascular shunting or stenting technologies, will be considered.&#8226; The treatment for bone healing, specifically technologies that create a wound environment more conducive to bone healing following injury to the extremities.Funding from this award mechanism must support a clinical trial and development-related efforts and may not be used for preclinical research studies. 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. The term &#8220;human subjects&#8221; is used in this BAA to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/Use of Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRMC Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) of record. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Submission Instructions, Appendix 5, for additional information.If the proposed study involves the use of a drug biologic or device that is not approved by the U.S. Food and Drug Administration (FDA), is not covered by an existing Investigational New Drug (IND) or Investigational Device Exemption (IDE), or uses a drug, biologic or device that is being used outside of its FDA-approved indication and population (e.g., off-label), evidence that an IND or IDE application has been submitted or will be submitted within 60 days of award is required.&#8226; If the proposed study will use clinical sites located outside of the United States and uses an investigational or off-label drug, biologic, or device, evidence that submission of the appropriate application to the regional regulatory authority has been or will be submitted within 60 days of award date is required.&#8226; The Government reserves the right to withdraw funding if the appropriate regulatory approval application (e.g., IND, IDE) has not been submitted to the FDA or regional regulatory authority within 60 days of the DoD award date or if the documented status of the regulatory approval has not been obtained within 6 months of the award date.- A business plan that describes the product and industry development progression through FDA marketing application, and to the commercial market (if applicable), must be submitted within 60 days of the award.&#8226; The Government reserves the right to withdraw funding if the business plan has not been submitted to the DoD within 60 days of the award date.The following are important aspects of a submission for the ERI:Relevance and Feasibility&#8226; The proposal/application should describe how the proposed intervention to be tested will offer significant potential impact for military Service members, Veterans or the general public over current standard of care.&#8226; The proposal/application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study.&#8226; The proposed clinical trial is initiated and can begin enrollment no later than 12 months after the award date.&#8226; The proposal/application should demonstrate how accrual goals will be achieved and how standards of care may impact the study population.&#8226; The proposal/application should demonstrate documented availability of and access to the drug, biologic, or device, if applicable, and/or other materials needed, as appropriate.Clinical Trial Elements&#8226; The proposed clinical trial should include clearly defined, measurable, and appropriate endpoints.&#8226; The proposal/application should include a clearly articulated statistical analysis plan, availability of appropriate statistical expertise, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study and support an FDA marketing application, if applicable.- The proposal/application should indicate the availability of a study coordinator(s) who will guide the clinical protocol through the local IRB or EC of record and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual.&#8226; If an IND or IDE application is required to be submitted to the FDA, the proposal/application should describe the availability of appropriate support to prepare, submit, and maintain the IND or IDE application.&#8226; If submission to a non-U.S. regional regulatory authority is required, the proposal/application should describe the availability of appropriate region-specific support to prepare, submit, and maintain the relevant application.&#8226; Inclusion of preliminary data relevant to the proposed research project and FDA marketing application is required. Examples of preliminary data include preclinical toxicology, manufacture validation, quality systems audit/gap analysis, a summary of preclinical studies, and any prior clinical experience inside or outside of the United States.- In addition to requisite preliminary data, the proposed research project must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.Institutional Elements&#8226; The proposal/application should include a post-award transition plan (including potential funding and resources) showing how the product would progress to the next clinical trial phase and/or delivery to the market after the successful completion of the work associated with this proposed award.&#8226; The proposal/application should clearly demonstrate strong institutional support.
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