DoD Multiple Sclerosis Pilot Clinical Trial Award

The summary for the DoD Multiple Sclerosis Pilot Clinical Trial Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.
DoD Multiple Sclerosis Pilot Clinical Trial Award: The MSRP Pilot Clinical Trial Award (PCTA) mechanism is being offered for the first time in FY15.
The PCTA supports early-phase, proof-of-principle clinical trials to investigate hypothesis-based, innovative interventions that have the potential to result in a profound impact on
management of MS symptoms. While therapeutic approaches proposed for testing through the PCTA must represent novel, hypothesis-based, “outside-the-box” approaches for treating MS symptoms, they may include therapies already in clinical use, or undergoing clinical testing, for other diseases, provided that the proposed use for MS would lead to a major advancement for treating one of the disease symptoms. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform MS patient care.
The PCTA will support clinical trials encompassing Phase 0, Phase I, or pilot Phase II for drugs or drug combinations, Class II or III for devices, or other types of trials that conduct early clinical testing of innovative approaches for MS symptoms. 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 the Investigator-Initiated Research Award (W81XWH-15-MSRP-IIRA). 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 pilot clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.
Examples of acceptable studies include but are not limited to the following:
• Identification of an appropriate population for the proposed study
• Identification of the dosage, duration, and/or delivery strategy of an intervention
• Evaluation of the feasibility of the intervention in MS
• Evaluation of efficacy and safety
The following are important aspects of submission for the PCTA:
• Pre-application is required; application submission is by invitation only.
• The application must include scientific rationale and/or preliminary data relevant to MS and the proposed study.
• The proposed intervention to be tested should offer significant potential impact on the management of MS symptoms.
• The application should demonstrate documented availability of, and access to, a suitable patient population that will support a meaningful outcome for the study.
• The application should clearly describe the steps that will be taken to advance the intervention into the next stage of development following the conclusion of this award.
• Preclinical studies will not be supported by this mechanism.
• Investigational New Drug (IND) or Investigational Device Exemption (IDE) approvals, if applicable, must be in place before an award will be made.
• Clinical trials are expected to be initiated within 6 months of the award date.
Funding from the PCTA must support a clinical trial and cannot be used for preclinical research or correlative studies. Principal Investigators (PIs) seeking funding for preclinical or correlative studies should refer to the FY15 MSRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number: W81XWH-15-MSRP-IIRA).
Federal Grant Title: DoD Multiple Sclerosis Pilot Clinical Trial Award
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: W81XWH-15-MSRP-PCTA
Type of Funding: Cooperative Agreement, Grant
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: Sep 10, 2015
Original Application Deadline: Sep 10, 2015
Posted Date: Apr 28, 2015
Creation Date: Apr 28, 2015
Archive Date: Oct 10, 2015
Total Program Funding: $2,900,000
Maximum Federal Grant Award: $0
Minimum Federal Grant Award: $0
Expected Number of Awards: 3
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact
CDMRP Help Desk 301-682-5507
CDMRP Help Desk

Dept. of the Army -- USAMRAA 301-619-7144
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