OpportunityTitle: Spinal Cord Injury Research Program Clinical Trial Award - Rehabilitation
Description: The Clinical Trial Award &#150; Rehabilitation (CTA-R) supports rapid implementation of clinical trials with the potential to have a significant impact on the understanding of SCI and amelioration of its consequences. All studies must be focused on rehabilitative aspects of SCI. All studies must also be applicable to the health care needs of the military service members, their family members, and/or the U.S. veteran population. Funding from this award mechanism cannot be used for preclinical research studies. Principal Investigators (PIs) seeking funding for a preclinical research project should utilize one of the other applicable FY09 SCIRP award mechanisms (for more information about those mechanisms, see http://cdmrp.army.mil). PIs must clearly specify in the Clinical Protocol (main body of the application) which type of clinical trial is being proposed: Phase 0, Phase I, Phase II, Phase III or a combination. For descriptions of each type of clinical trial, please refer to http://www.clinicaltrials.gov and http://www.fda.gov/cder/guidance/6384dft.htm. In addition, refer to the Application Instructions &amp; General Information, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. The proposed clinical trial is expected to begin within 12 months of the award date. CTA-R applications should: Demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. Describe clearly defined, focused endpoints for the proposed clinical trial that correspond to the design and sample size proposed. DOD Spinal Cord Injury Clinical Trial Award 4 Clearly articulate the statistical analyses plan. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results for patients with the specified disease/condition. Include a study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board (HSRRB), and other regulatory approval processes; coordinate activities from all sites participating in the trial, and coordinate participant accrual. The clinical trial should have a potentially high impact. The focus must be clearly on SCI rehabilitation. Investigational New Drug (IND) approvals, if applicable, should be initiated or completed before submission to the CTA-R mechanism. If IND/IDE (investigational device exemption) approval is not received by June 30, 2010, the Government reserves the right to revoke funding. Demonstrate institutional support. Multi-institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for communication and data transfer between the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the Clinical Protocol. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials. Use of Human Subjects and Human Biological Substances: All Department of Defense (DOD)-funded research involving human subjects and human biological substances must be reviewed and approved by the USAMRMC Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to local IRBs. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the local review board. Allow a minimum of 6 months for regulatory review and approval processes for studies involving human subjects. Refer to Application Instructions &amp; General Information, Appendix 6, for detailed information. Encouraged DOD Collaboration and Alignment: Alignment with current DOD research and collaboration with military researchers and clinicians is encouraged. The following websites may be useful in identifying information about ongoing DOD areas of research interest within the FY09 SCIRP Areas of Encouragement: Defense Technical Information Center http://www.dtic.mil Congressionally Directed Medical Research Programs http://cdmrp.army.mil U.S. Army Medical Research and Materiel Command https://mrmc.amedd.army.mil Air Force Research Laboratory http://www.wpafb.af.mil/afrl DOD Spinal Cord Injury Clinical Trial Award 5 Navy and Marine Corps Public Health Center http://www-nehc.med.navy.mil/ U.S. Department of Veterans Affairs, Office of Research and Development www.research.va.gov Office of Naval Research http://www.onr.navy.mil/ U.S. Army Research Laboratory http://www.arl.army.mil U.S. Naval Research Laboratory www.nrl.navy.mil Defense Advanced Research Projects Agency http://www.darpa.mil/ U.S. Army Medical Research Acquisition Activity http://www.usamraa.army.mil Naval Health Research Center http://www.nhrc.navy.mil/ Office of the Under Secretary of Defense for Acquisition, Technology and Logistics http://www.acq.osd.mil/
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil  &lt;br/&gt;eReceipt HELP: 301-682-5507; help@cdmrp.org &lt;br/&gt;