DoD Spinal Cord Injury Clinical Trial Award
The SCIRP Clinical Trial Award (CTA) mechanism was first offered in FY12. Since then, 17 CTA applications have been received, and 2 have been recommended for funding. This award mechanism supports the rapid implementation of Phase 0, I, or II clinical trials with the potential to have a major impact on treatment or management of SCI and its consequences. 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://cdmrp.org/Program_Announcements_and_Forms/. If the study proposed involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for its investigational use, then an Investigational New Drug (IND) application to the FDA may be required and must be submitted to the FDA prior to the grant submission. If the proposed clinical trial involves an investigational device that has not been approved or cleared by FDA for its investigational clinical use, the study may be required to comply with the FDA Investigational Device Exemption (IDE) regulations. If applicable, the IDE application must be submitted prior to the grant submission. The Government reserves the right to withdraw funding if the documented status of the IND or IDE has not been obtained within 6 months of the award date. The following are important aspects of submission for the Clinical Trial Award: • The proposed clinical trial is expected to begin no later than 12 months after the award date. • The proposed intervention to be tested should offer significant potential impact for individuals living with SCI and its consequences. • The proposed clinical trial should be directly applicable to the health care needs of military Service members, Veterans, or other individuals living with SCI. • 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. • Inclusion of preliminary data relevant to the proposed clinical trial is required; Phase I or pilot clinical trial data are required for Phase II clinical trial applications. • The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the proposed clinical trial. 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 proposed clinical trial should include clearly defined and appropriate endpoints, and use standard outcome measures, if applicable. • 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 proposed clinical trial. • 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. • Partnerships between clinicians and bio-engineers are encouraged. • The application should demonstrate utilization of the spinal cord injury Common Data Element (CDE) standards 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
