DoD Reconstructive Transplant, Advanced Technology Development Award
The FY21 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation. Important aspects of this award mechanism include: • Study Design and Feasibility: The proposed study design should be clearly described, rigorous, well-integrated, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, if applicable. It should be clear how the proposed study design of this project will position the product for the next phase of development as described in the post-award Transition Plan (Attachment 9). • Impact/Military Relevance: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY21 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed should be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers, or clinicians, as well as the general public. Collaboration with military and VA researchers and clinicians is encouraged but not required. • Transition Plan: The post-award Transition Plan (Attachment 9) should include potential funding and resources and show how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the successful completion of this award. A regulatory strategy as applicable to the proposed research/product should also be included. • Preliminary Data: Proof of concept demonstrating potential utility of the proposed product, or a prototype/preliminary version of the proposed product, must already be established. Preliminary and/or published data that are relevant to reconstructive transplantation, and that support the rationale for the proposed study, must be included (these data may be unpublished if from a member of the research team, or from the published literature). Proposed research and products to be developed may be materiel products such as drugs, biologic agents, or devices, or knowledge-based products such as technical reports and clinical practice guidelines that inform clinical/operational decisions and promote evidence-based changes in clinical practice and standard of care. Proposed research may include animal research and/or human subjects research, as appropriate; however, clinical trials are not allowed under this funding opportunity.