The synopsis for this grant opportunity is detailed below, following
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Description of Modification
Due to extreme weather conditions experienced in the last week, the closing date for receipt of pre-applications is extended until July 5, 2012.
Modification to Previous
Funding Opportunity Number:
May 31, 2012
Jul 03, 2012
Original Closing Date for Applications:
Oct 01, 2012
Current Closing Date for Applications:
Oct 01, 2012
Oct 31, 2012
Funding Instrument Type:
Category of Funding Activity:
Science and Technology and other Research and Development
Expected Number of Awards:
Estimated Total Program Funding:
Military Medical Research and Development
Cost Sharing or Matching Requirement:
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Additional Information on Eligibility:
Dept. of the Army -- USAMRAA
The SCIRP Clinical Trial Award (CTA) mechanism was first offered as the Clinical Trial Award Rehabilitation (CTA-R) in FY09. Forty-four CTA-R applications were received, and 10 were recommended for funding. NEW for FY12: The award mechanism has been modified to support the rapid implementation of all Phase 0, I, or II clinical trials with the potential to have a major impact on treatment or management of spinal cord injury and its consequences, and is no longer limited to studies focused on rehabilitation. The FY12 SCIRP is particularly interested in comparative effectiveness studies.
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 with 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 on clinical research, 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 U.S. Food and Drug Administration (FDA) for its investigational use, then an Investigational New Drug (IND) application to the FDA may be required and, if applicable, must be submitted to the FDA prior to the application 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 application 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 spinal cord injury and its consequences.
The proposed clinical trial should be directly applicable to the health care needs of military Service members, Veterans, and other individuals living with SCI.
The proposed research project 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 research project is required; Phase I or pilot clinical trial data are required for Phase II clinical trial applications.
The application must demonstrate availability of, and access to, a suitable study 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 must demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate.
The proposed clinical trial must 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 study.
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 must 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 successful completion of the SCIRP Clinical Trial Award.
The application should demonstrate the clinical expertise of the PI.
The application must demonstrate evidence of 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.
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