DoD Peer Reviewed Orthopaedic, Clinical Trial Award

Description

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Department of Defense Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., during training, leisure activities, resultant from old injuries) present one of the greatest threats to the readiness of our Service Members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and affects military readiness.Although the PRORP is interested in supporting military-focused research, research supported by the PRORP is expected to also apply to all individuals who have sustained a major orthopaedic injury.With the initiation of the Arthritis Research Program, the FY24 PRORP may not fund arthritis research; however, research that addresses conditions or health abnormalities related to arthritis is permitted provided the proposed research addresses the selected Focus Area.The PRORP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of military combat or service-related orthopaedic injuries that significantly impact unit readiness and return-to-duty/work rates. Applicants are encouraged to address how the proposed research will support patient care closer to the point of injury and/or allow patients to more quickly return to duty/work. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.The FY24 PRORP CTA differs from the FY24 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects that may or may not include a clinical trial, whereas the CTA is restricted to clinical trials only.Funding from this award mechanism must support a clinical trial and may not be used for animal or preclinical studies. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.All applications submitted to this program announcement, regardless of the selected Focus Area, are eligible for Research Level 1.Collaborative Care Option (Research Level 2): Applications submitted to the FY24 PRORP CTA, with Focus Area Translation of Early Findings – Soft Tissue Trauma, are eligible for a Collaborative Care Option (Research Level 2); refer to Section II.D.5, Funding Restrictions. The Collaborative Care Option provides additional support to encourage collaborative interdisciplinary research among physical therapists, occupational therapists, prosthetists, surgeons, and other orthopaedic care providers. The proposed research should include both surgical and rehabilitation strategies that create a cohesive project. Surgical strategies are reconstruction and repair and/or application of biologics, pharmaceuticals, and devices for the purpose of restoration of native architecture, composition, and function of traumatically injured tissues. Rehabilitative strategies are those that restore function following injury or illness, with the goal of optimal health and independence. Projects should integrate principles and approaches from surgical and rehabilitative strategies, beyond what each approach would provide by itself, with the goal of optimizing form, function, and independence for those who have sustained traumatic orthopaedic injuries. The rehabilitation strategy and the standard of care must be specified. Projects that follow patients across the continuum of care are highly encouraged. To encourage meaningful and productive multidisciplinary collaborations, projects submitted for this option must include at least one investigator with orthopaedic rehabilitation expertise and at least one clinician who specializes in orthopaedic or trauma care. A Letter of Collaboration is required from each specialist (i.e., rehabilitation expert and surgeon) who is serving as Key Personnel, excluding the Principal Investigator (PI), on the application. A clinician is defined as an individual who is credentialed (possesses the necessary degrees, licenses, and other certifications) and practicing as a care provider in a relevant capacity.If the proposed research includes a clinical trial of an investigational product to be conducted at international sites, an application to the relevant national Regulatory Agency of each host country must be submitted within 6 months of the award date.The government reserves the right to withdraw funding if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application and/or international regulatory application is necessary but has not been submitted within 6 months of the award date.For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.Key aspects of the PRORP CTA mechanism:• Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 6 months after the award date, or 12 months after the award date for studies regulated by the Regulatory Agency.• Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical trial is required.• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.• Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.• Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled.• Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.Women’s Health Research: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women's health.Use of DOD or VA Resources: If the proposed research involves access to DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.For the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any relevant international Regulatory Agency unless otherwise noted.If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an IND application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be submitted to the relevant Re

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