DoD Peer Review Orthopaedic Clinical Trial Award

The PRORP CTA mechanism was first offered in FY09. Since then, 156 CTA applications have been received, and 31 have been recommended for funding.

The PRORP CTA is intended to support the rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries or non-battle 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.

The FY19 PRORP CTA differs from the FY19 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only.

). The Rehabilitation Option provides additional support to encourage collaborative interdisciplinary research among physical therapists, occupational therapists, prosthetists, surgeons, and other orthopaedic care providers. Projects 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. 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 from the rehabilitation expert is required for this option. 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.

Funding from an FY19 PRORP CTA must support a clinical trial(s) and may not be used for preclinical research studies. Proposed projects may range from small proof-of-concept trials (i.e., pilot, first in human, or Phase 0) to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. New FY19 definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.

If the proposed clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the FDA within 6 months of the award date. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.

If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required, or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA within 6 months of the award date. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial.

If the clinical trial of an investigational product will be conducted at international sites, evidence that an application to the relevant national regulatory agency of the host country(ies) has been submitted within 6 months of the award date is required.

Refer to Attachment 9, Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted within 6 months of the award date.

Animal research is not allowed under the FY19 PRORP CTA. Principal Investigators (PIs) seeking funding for a preclinical research project should consider applying to the FY19 PRORP Applied Research Award (Funding Opportunity Number: W81XWH-19-PRORP-ARA) mechanism, which can be accessed at https://cdmrp.army.mil/funding/.