DoD Traumatic Brain Injury and Psychological Health, Patient-Centered Research Award

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Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRP research programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope. The FY22 TBIPHRP PCRA intends to bridge the gap between research, practice, and policy by building a knowledge base on how interventions, clinical practices/guidelines, tools, and policies can be deployed to targeted populations at the appropriate time at the point of need. Funding from this award mechanism must support clinical research or clinical trials but cannot be used for preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects, human subject data/records, and human anatomical substances. This award may not be used to support studies requiring an exception from informed consent (EFIC). The FY22 PCRA may support (not all inclusive): •   Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. •   Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. •   Analysis of existing data or resources to inform clinical practice •   Modification of established clinical tools for their intended population or environment •   Analysis of existing clinical tools to maximize patient-relevant outcomes •   Identification and analysis of the circumstances that create a need to stop or reduce (“de- implement”) the use of interventions, tools, policies, and guidelines that are ineffective, unproven, low-value, or harmful is within scope. The following are important aspects of the FY22 TBIPHRP PCRA: •   The application must include Community-Based Participatory Research (CBPR) approaches in the development and execution of the clinical research/trial. CBPR approaches should be documented in Attachments 11 and 12. •   Inclusion of preliminary data relevant to the proposed clinical research/trial is required. •   As applicable, the application should demonstrate availability of and access to a suitable patient population that will support a meaningful outcome for the study. •   If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date. •   If applicable, the application should demonstrate documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study/trial. •   Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).

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