DoD Multiple Sclerosis, Clinical Trial Award

The summary for the DoD Multiple Sclerosis, 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, Clinical Trial Award: The MSRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of multiple sclerosis. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations. The FY23 MSRP CTA offers two funding levels (Refer to Section II.D.5, Funding Restrictions). Only one funding level may be chosen per application and the choice of application category is at the discretion of the applicant. The requested budget at each funding level must be justified and appropriate to the scope of the clinical trial proposed. The following are generalized descriptions of the scope of research appropriate for each funding level: · Funding Level 1 (FL1) supports small-scale, early-phase, proof-of-principle clinical trials to demonstrate feasibility or inform the design of more advanced trials, or other clinical trials that are appropriate for this funding level. Preliminary data relevant to the proposed clinical trial are required. · Funding Level 2 (FL2) supports larger-scale clinical trials at phase 1 or phase 2 that seek to show preliminary evidence of safety or efficacy (i.e., benefit of clinical or paraclinical outcomes) in relevant patient populations. Strong justification should be provided, which could include but is not limited to intervention type, trial duration, sample size, outcome measures, assessment tools, and frequency of assessment. Preliminary data relevant to the proposed clinical trial are required. For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted. Key aspects of the FY23 MSRP CTA Mechanism: · Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical trial is required for both funding levels. · Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 6 months after the award date. · Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. · Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. · Personnel and Environment: The application should demonstrate the study team's expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of FDA processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, are fulfilled. · Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards. Funding from this award mechanism must support a clinical trial.
Federal Grant Title: DoD Multiple Sclerosis, Clinical Trial Award
Federal Agency Name: Dept of the Army USAMRAA (DOD-AMRAA)
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: HT9425-23-MSRP-CTA
Type of Funding: Cooperative Agreement
CFDA Numbers: 12.420
CFDA Descriptions: Information not provided
Current Application Deadline: October 6th, 2023
Original Application Deadline: October 6th, 2023
Posted Date: April 14th, 2023
Creation Date: April 14th, 2023
Archive Date: November 5th, 2023
Total Program Funding: $7,700,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards: 3
Cost Sharing or Matching: No
Last Updated: April 14th, 2023
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity below), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact
CDMRP Help Desk
Phone: 301-682-5507
Email: [email protected]
CDMRP Help Desk
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