Peer Reviewed Orthopaedic Integrated Clinical Trial Award

Description

The PRORP Integrated Clinical Trial Award (ICTA) supports the rapid implementation of an interdisciplinary clinical trial that integrates both surgical and rehabilitation strategies and has the potential to have a major impact on the treatment of combat-related orthopaedic injuries and/or the treatment of non-battle injuries that significantly impact unit readiness and return-to-duty/- work rates. Projects that follow patients across the continuum of care are highly encouraged. The 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 result in alone, with the goal of optimizing form, function, and independence for those who have sustained traumatic orthopaedic injuries. Care should be taken to avoid or account for confounding factors in the analyses. Required Qualified Collaborator(s): The ICTA supports collaborative interdisciplinary research between/among physical therapists, occupational therapists, prosthetists, surgeons, and other orthopaedic care providers. To encourage meaningful and productive multidisciplinary collaborations, the project must include at least one investigator with orthopaedic rehabilitation expertise and at least one clinician who specializes in orthopaedic or trauma care. 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. Biographical sketches should include appropriate documentation of credentials. It is the responsibility of the Principal Investigator (PI) and the collaborating investigator(s) to describe how their combined expertise will better address the research question, why the work should be performed through collaboration rather than through separate efforts, and how the research design will create a reciprocal flow of ideas and information between the multiple disciplines represented. The proposed collaboration should involve substantial contributions from each of the key collaborators identified, with evidence of significant intellectual input from each key collaborator into the design of the project. The PI must submit a Qualified Collaborator Statement that clearly describes the proposed collaborator(s), the collaboration, and addresses how each of the criteria below are met. Use Attachment 9: Study Personnel and Organization to provide this statement. In addition, each collaborator must provide a letter of collaboration describing his/her involvement in the proposed work. Use Attachment 2 to provide this documentation (see Section II.D.2.b.ii, Full Application Submission Components, Attachment 2: Supporting Documentation). The following criteria must be met for the required Qualified Collaborator(s): • A Qualified Collaborator must be an investigator with orthopaedic rehabilitation expertise or a clinician who specializes in orthopaedic or trauma care. • The Qualified Collaborator(s) must significantly contribute to the project such that the proposed work could not be accomplished without his/her involvement. This is expected to include both intellectual input and research resources (e.g., supplies, reagents, equipment, personnel, services, tissue samples, or access to patients or populations). • The Qualified Collaborator(s) and PI must each contribute a minimum of a 5% level of effort to the project. Contribution of the Qualified Collaborator(s) and PI should be reflected in the application budget. All applications are required to articulate the relevance of the proposed project to military and/or Veteran populations affected by orthopaedic injury. Collaboration with military and VA researchers and/or clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged. Preclinical animal research is not allowed under the FY17 PRORP ICTA. Funding from this award mechanism must support one cohesive clinical trial 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 safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information on how to distinguish clinical research from clinical trials, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. PIs seeking funding for a preclinical research project should consider one of the other FY17 PRORP award mechanisms, which can be accessed at http://cdmrp.army.mil/funding/default. If the 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 and must be submitted to the FDA within 6 months of the award date. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA within 6 months of the award date, or that the device is exempt from an IDE, or qualifies for an abbreviated IDE, is required. The Government reserves the right to withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA within 6 months of the award date, or if documented status of the IND or IDE has not been obtained within 12 months of the award date. The following are important aspects of submission for the ICTA: • The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies. • The proposed intervention to be tested should offer significant potential impact for military personnel and Veterans with combat-related orthopaedic injuries or non-battle orthopaedic injuries that impact unit readiness and return to duty/work. • The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. • The application should describe the planned indication for the product label, if appropriate. Likewise, it should include an outline of the development plan and regulatory strategy required to support that indication. • The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The applicant should discuss how accrual goals will be achieved and how standards of care may impact the study enrollment. • The application should demonstrate documented availability of, and access to, the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices). • The application should demonstrate the study team has experience interacting with the FDA, to include previous FDA submissions, if applicable. • The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. • The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. • The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. For FDA-regulated studies, compliance with 21 CFR 11 is required. • The application should include a clearly articulated safety management plan outlining how safety and pharmacovigilance will be conducted, as applicable. • The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance. • The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other Federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. • For studies determined to be greater than minimal risk to human subjects by the local IRB of record, the Department of Defense (DoD) requires an independent research monitor with expertise consistent with the nature of risk(s) identified within the research project. If applicable, refer to the General Application Instructions, Appendix 6, for more information on study reporting authorities and responsibilities of the research monitor. • The application should include a Transition Plan (including potential funding and resources) showing how the product will progre

Agency Contact

More from Defense Health Agency Contracting Activity - DHACA