DoD Spinal Cord Injury Clinical Trial Award
The SCIRP Clinical Trial Award mechanism was first offered in FY12. Since then, 30 Clinical Trial Award applications have been received, and 7 have been recommended for funding. The SCIRP Clinical Trial Award supports human subjects research with the potential to have a major impact on the treatment or management of SCI and its consequences in military Service Members, Veterans, or other individuals. Funding from this award mechanism must support a 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 exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. 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 prior to the application submission deadline. 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 prior to the application submission deadline, or that the device is exempt from an IDE, is required. Documentation of approval of the IND or IDE must be obtained and submitted to the CDMRP Help Desk (help@eBRAP.org) prior to Programmatic Review; otherwise, the Government reserves the right to withdraw the application. The following are important aspects of submission for the Clinical Trial Award: The proposed clinical trial is expected to begin no later than 6 months after the award date. The proposed intervention to be tested should offer significant potential impact for individuals living with SCI and its consequences. Inclusion of preliminary data relevant to the proposed clinical trial is required. 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, and include an outline of the development plan 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 PI should discuss how accrual goals will be achieved and how standards of care may impact the study population. 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 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, 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. The application should include a clearly articulated safety management plan, outlining how safety 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 regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the SCIRP Clinical Trial Award. The application should clearly demonstrate strong institutional support. The application should acknowledge the commitment to filing the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov. The application should demonstrate utilization of the spinal cord injury Common Data Elements (CDEs) developed through the collaboration of the International Spinal Cord Society, the American Spinal Injury Association, and the National Institute of Neurological Disorders and Stroke CDE team, as referenced at http://www.commondataelements.ninds.nih.gov/SCI.aspx. Additionally, the Government reserves the right to identify repositories for submission of data for archive. Any costs associated with submission of data to such repositories will be addressed during award negotiations.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
