OpportunityTitle: DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation
Description: The SCIRP Clinical Trial Award &#239;&#191;&#189; Rehabilitation (CTA-R) mechanism was first offered in FY09. Since then, 30 Clinical Trial Award &#239;&#191;&#189; Rehabilitation applications have been received, and 7 have been recommended for funding. The CTA-R supports rapid implementation of Phase 0, I, or II clinical trials with the potential to have a significant impact on the understanding of spinal cord injury and amelioration of its consequences. All studies must be focused on rehabilitative aspects of SCI, and be applicable to the health care needs of military Service members, veterans, and/or their caregivers and family members. Funding from this award mechanism must support a clinical trial and cannot 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 utilize one of the other applicable FY11 SCIRP award mechanisms/funding opportunities being offered (for more information about those mechanisms, see http://cdmrp.army.mil). The term &#239;&#191;&#189;human subjects&#239;&#191;&#189; 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. Clinical trials require informed consent on the subject, and may include identifiable information. 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 study 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 &#239;&#191;&#189; Rehabilitation: &#239;&#191;&#189; The proposed clinical trial is expected to begin no later than 12 months after the award date. &#239;&#191;&#189; Demonstrate a clear focus on SCI rehabilitation. &#239;&#191;&#189; Be applicable to the health care needs of military Service members, veterans, and/or their caregivers and family members. &#239;&#191;&#189; The proposed research project should also be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. &#239;&#191;&#189; Include preliminary data that are relevant to the proposed research project; Phase I or pilot clinical trial data are required for Phase II clinical trial applications. &#239;&#191;&#189; Demonstrate availability of and access to a suitable human subject population that will support a meaningful outcome for the study; include appropriate controls; discuss how accrual goals will be achieved, and how standards of care may impact the study population. &#239;&#191;&#189; Describe appropriate and clearly defined endpoints for the proposed clinical trial that correspond to the design and sample size proposed. &#239;&#191;&#189; Clearly articulate the statistical analysis plan. Include appropriate statistical expertise and provide a power analysis reflecting sample size projections that will clearly answer the objectives of the study. &#239;&#191;&#189; Discuss the potential impact of the study results for patients with SCI. &#239;&#191;&#189; Include a study coordinator(s) who will guide the clinical trial protocol through the local Institutional Review Board (IRB) of record, Human Subjects Research Review Board (HSRRB), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. &#239;&#191;&#189; Include a Transition Plan that describes how this project will continue to the next level after the end of this period of performance. &#239;&#191;&#189; Demonstrate the clinical expertise of the PI. &#239;&#191;&#189; Demonstrate institutional support. &#239;&#191;&#189; Partnerships between clinicians and bio-engineers are encouraged. &#239;&#191;&#189; Training of the next generation of scientists and clinicians is encouraged; therefore, graduate and medical students, residents, postdoctoral fellows, and clinician-scientists are encouraged to be part of the application. &#239;&#191;&#189; Utilize 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 will be addressed during award negotiations. NESTED NEW INVESTIGATOR OPTION The SCIRP is offering opportunities for training of graduate students, medical students, residents, postdoctoral fellows, and clinician-scientists new to SCI research, as an option for the Clinical Trial Award &#239;&#191;&#189; Rehabilitation. The intent of the Nested New Investigator Option is to provide mentored research opportunities in SCI research. It is expected that the training will provide new investigators with a meaningful and productive experience in SCI research. Only one Nested New Investigator can be requested per proposal. Applications must include the Nested New Investigator&#239;&#191;&#189;s name, biosketch, and a letter indicating their professional goals, commitment, and intentions in furthering their interest in SCI research (the PI cannot be named as the Nested New Investigator). A letter of support is also required from the Mentor. At the application submission deadline, Nested New Investigators must be either: &#239;&#191;&#189; A graduate student, medical student, resident, or post-doctoral fellow participating in a mentored training program, or &#239;&#191;&#189; A clinician with clinical duties and/or responsibilities who is new to scientific research (i.e., no history of independent research funding in any scientific discipline), or &#239;&#191;&#189; A clinician with clinical duties and/or responsibilities who has research experience but is new to the SCI field (i.e., no history of independent research funding or scientific publications in the field of SCI research). Use of Human Subjects and Human Anatomical Substances: The term &#239;&#191;&#189;human subjects&#239;&#191;&#189; 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. All DOD-funded research involving new and ongoing research with human subjects and human anatomical substances must be reviewed and approved by the US Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to the local IRB of record. Local IRB approval at the time of submission is NOT required. If recommended for funding, the PI will be required to submit a formal clinical protocol that conforms to HRPO requirements. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the local IRB. Allow a minimum of 4 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 5, for more information.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: 301-682-5507