OpportunityTitle: DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation
Description: The Clinical Trial Award - Rehabilitation (CTA-R) mechanism was first offered in FY09. Since then, 18 Clinical Trial Award - Rehabilitation award applications have been received, and 4 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. All studies must also be applicable to the health care needs of the Armed Forces, their family members, and/or the U.S. veteran population. A clinical trial is defined as a prospective accrual of patients where an intervention is tested on a human subject for a measurable outcome for safety and/or efficacy. Clinical trials require informed consent on the subject, and may include identifiable information. Funding from this award mechanism cannot be used for preclinical (in vitro and/or in vivo laboratory animal) studies. Principal Investigators (PIs) seeking funding for a preclinical research project should utilize one of the other applicable FY10 SCIRP award mechanisms (for more information about those mechanisms, see http://cdmrp.army.mil). PIs must clearly specify in the Clinical Protocol which type of clinical trial is being proposed, and indicate the phase of trial and/or class of device, as appropriate. For descriptions of each type of clinical trial, please refer to http://www.clinicaltrials.gov. The proposed clinical trial is expected to begin within 12 months of the award date. CTA-R applications should: &#149; Demonstrate a clear focus on SCI rehabilitation. &#149; Demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. &#149; Describe clearly defined, focused endpoints for the proposed clinical trial that correspond to the design and sample size proposed. &#149; Clearly articulate the statistical analyses plan. Include appropriate statistical expertise and provide a power analysis reflecting sample size projections that will clearly answer the objectives of the study. &#149; Discuss the potential impact of the study results for patients with SCI. &#149; 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. &#149; Investigational New Drug (IND) or Investigational Device Exemption (IDE) approvals, if applicable, should be initiated or completed before submission to the Clinical Trial Award- Rehabilitation mechanism. If IND/IDE approval is not received within 6 months of the award date, the Government reserves the right to revoke funding. &#149; Include a Transition Plan that describes how this project will continue to the next level after the end of this period of performance. &#149; Demonstrate the clinical expertise of the PI. &#149; Partnerships between clinicians and bio-engineers are encouraged. &#149; 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. New for FY10: 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 &#150; 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&#146;s name, biosketch, and a letter indicating their professional goals, commitment and intentions in furthering their interest in SCI research. A letter of support is also required from the Mentor. At the application submission deadline, Nested New Investigators must be either: &#149; A graduate student, medical student, resident, or post-doctoral fellow participating in a mentored training program, or &#149; 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 &#149; 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).
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: PA HELP:  301-619-7079; cdmrp.pa@amedd.army.mil &lt;br/&gt;eReceipt HELP:  301-619-5507; help@cdmrp.org &lt;br/&gt;