Opportunity Information: Apply for HT942524MSRPCTA
The DoD Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) is a Department of Defense grant opportunity designed to accelerate the launch and execution of clinical trials that could meaningfully improve the treatment or day-to-day management of multiple sclerosis. The program is geared toward studies that can move quickly into the clinic and generate actionable results, whether that means testing a promising therapeutic idea for the first time in people or running a more developed trial to estimate safety and early signs of benefit. Trials supported under this mechanism can evaluate a wide range of interventions and strategies, including drugs and biologics, medical devices, clinical guidance approaches, and newer technologies or methods that may change how MS is treated or monitored.
A central feature of this opportunity is that applicants must choose one of two funding levels, and only one level can be selected per application. The funding level should match the maturity and scope of the proposed trial, and the budget must be tightly justified based on what the trial is realistically designed to accomplish. Funding Level 1 (CTA-FL1) is intended for smaller, early-phase, proof-of-principle studies, such as pilot work, feasibility trials, first-in-human efforts, or phase 0 style studies. These projects are meant to show whether an approach is workable in practice or to generate the information needed to design a larger, more definitive trial. Funding Level 2 (CTA-FL2) supports larger phase 1 or phase 2 clinical trials aimed at generating preliminary evidence of safety and/or efficacy, including effects on clinical outcomes (how patients feel or function) or paraclinical outcomes (for example, imaging or biomarker-based measures). For Level 2 projects, the program expects a stronger, more detailed justification for design choices such as the intervention, trial length, sample size, endpoints, measurement tools, and assessment schedule.
This award mechanism places heavy emphasis on readiness to execute. Preliminary data are required for both funding levels, and the expectation is that the data are directly relevant to the proposed trial, ideally coming from studies in people with MS. The trial must also be able to start quickly after award: the clinical trial is expected to begin within 12 months of the award date, or within 18 months if the study is regulated by a Regulatory Agency (defined here as the U.S. Food and Drug Administration or an applicable international regulator). In practice, this means applicants need to show they have done enough groundwork, such as protocol development and operational planning, to avoid long delays after funding.
Applications must also demonstrate that the study can actually enroll the right participants. Reviewers will look for evidence of access to an appropriate MS patient population and a credible recruitment and accrual plan that can hit enrollment targets. The application should explain how enrollment goals will be met and include an inclusion strategy for women and minorities that fits the scientific aims of the trial. An exception is noted for certain studies using human biospecimens or datasets that cannot be linked back to identifiable individuals or demographic attributes and are typically exempt from IRB review; those studies are exempt from the demographic inclusion strategy requirement as described.
Because the mechanism supports interventional clinical research, applicants are expected to address intervention availability, risk, and safety management in a concrete way. The proposal should document that the drug, compound, device, or other required materials will be available for the full duration of the study. It must clearly describe anticipated risks, including potential safety issues and adverse events, and lay out steps to minimize risk to participants and staff or manage risks that cannot be eliminated. A key operational requirement is an emergency care plan for study-related injuries, including clarity on who pays for treatment if an adverse event occurs as a result of trial participation.
The award also prioritizes proven clinical trial capability and infrastructure. Applications are expected to show that the research team has the expertise to run a clinical trial end-to-end, including appropriate statistical skills, data handling capabilities, and familiarity with FDA processes when applicable. The program specifically calls for inclusion of study coordinator support to shepherd the protocol through the local IRB of record and any other regulatory approvals, coordinate activities across participating sites, and manage participant accrual. Strong institutional support is expected, and if the project requires an FDA regulatory sponsor, the application should show a commitment and capacity to fulfill sponsor responsibilities under 21 CFR 312, Subpart D.
Finally, applicants must provide a rigorous statistical analysis and data management approach. The proposal should include a clear statistical analysis plan and a power analysis that justifies the sample size and demonstrates that the trial can answer its stated objectives. A data management plan is also required, including use of an appropriate database to protect data integrity and security. If a Regulatory Agency requires it, the trial must use a database compliant with 21 CFR Part 11 and follow appropriate data standards, reflecting the expectation that data will be managed at a level suitable for regulatory review and high-confidence interpretation.
Administrative details from the notice include: the funding opportunity title is "DoD Multiple Sclerosis, Clinical Trial Award" (opportunity number HT942524MSRPCTA), offered as a discretionary grant through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA). Eligibility is listed as unrestricted, the CFDA number is 12.420, and the original closing date is October 7, 2024. The notice anticipates making about three awards, underscoring that this is a competitive mechanism focused on well-justified, trial-ready proposals with a realistic path to near-term clinical impact.Apply for HT942524MSRPCTA
- The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Multiple Sclerosis, Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on 2024-04-19.
- Applicants must submit their applications by 2024-10-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Unrestricted.
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Frequently Asked Questions (FAQs): DoD Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA)
What is the DoD Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA)?
The MSRP Clinical Trial Award (CTA) is a Department of Defense funding opportunity intended to accelerate the launch and execution of interventional clinical trials that could meaningfully improve the treatment or day-to-day management of multiple sclerosis (MS). The focus is on trials that can move quickly into the clinic and produce actionable results.
What kinds of studies is this award designed to support?
This mechanism supports clinical trials that are ready to start and are structured to generate early, decision-making evidence (for example, feasibility, safety, and early signals of benefit). It can support trials testing a promising idea for the first time in people or more developed trials designed to estimate safety and early efficacy.
What types of interventions can be evaluated under this award?
Supported trials may evaluate a wide range of interventions and strategies, including drugs and biologics, medical devices, clinical guidance approaches, and newer technologies or methods that may change how MS is treated or monitored.
How many funding levels are available, and can an applicant choose both?
There are two funding levels, and applicants must choose one. Only one funding level can be selected per application.
What is Funding Level 1 (CTA-FL1) intended for?
Funding Level 1 (CTA-FL1) is intended for smaller, early-phase, proof-of-principle studies. Examples include pilot studies, feasibility trials, first-in-human efforts, or phase 0 style studies designed to show whether an approach is workable and/or generate information needed to design a larger, more definitive trial.
What is Funding Level 2 (CTA-FL2) intended for?
Funding Level 2 (CTA-FL2) supports larger phase 1 or phase 2 clinical trials intended to generate preliminary evidence of safety and/or efficacy. This can include effects on clinical outcomes (how patients feel or function) and paraclinical outcomes (such as imaging or biomarker-based measures).
What additional expectations apply to Funding Level 2 applications?
For Level 2 projects, the program expects a stronger and more detailed justification for key design choices, including the intervention, trial length, sample size, endpoints, measurement tools, and the assessment schedule.
Is preliminary data required to apply?
Yes. Preliminary data are required for both funding levels. The expectation is that the data are directly relevant to the proposed trial and, ideally, derived from studies in people with MS.
How quickly must the clinical trial start after an award is made?
The clinical trial is expected to begin within 12 months of the award date, or within 18 months if the study is regulated by a Regulatory Agency (defined in the notice as the U.S. Food and Drug Administration or an applicable international regulator).
What does the program mean by being "ready to execute"?
The program places heavy emphasis on readiness, meaning applicants should have done enough groundwork (such as protocol development and operational planning) to avoid long delays after funding and to enable a rapid study start consistent with the required timelines.
What are the expectations for participant recruitment and enrollment?
Applications are expected to show access to an appropriate MS patient population and provide a credible recruitment and accrual plan that can meet enrollment targets. Reviewers will look for evidence that the study can realistically enroll the right participants on schedule.
Is an inclusion strategy for women and minorities required?
Yes. The application should include an inclusion strategy for women and minorities that aligns with the scientific aims of the trial.
Are there any exceptions to the women and minority inclusion strategy requirement?
An exception is described for certain studies using human biospecimens or datasets that cannot be linked back to identifiable individuals or demographic attributes and are typically exempt from IRB review. Those studies are exempt from the demographic inclusion strategy requirement as described in the notice.
What must applicants address regarding intervention availability?
The proposal should document that the drug, compound, device, or other required materials will be available for the full duration of the study.
What safety and risk information is required in the application?
Applicants must clearly describe anticipated risks, including potential safety issues and adverse events. The application should also explain steps to minimize risks to participants and staff and how risks that cannot be eliminated will be managed.
Is an emergency care plan required for study-related injuries?
Yes. A key operational requirement is an emergency care plan for study-related injuries, including clarity on who pays for treatment if an adverse event occurs as a result of trial participation.
What expectations are there for the research team and trial infrastructure?
Applications are expected to demonstrate that the team has the expertise and infrastructure to run a clinical trial end-to-end. This includes appropriate statistical skills, data handling capabilities, and familiarity with FDA processes when applicable.
Does the program require study coordinator support?
Yes. The program specifically calls for inclusion of study coordinator support to shepherd the protocol through the local IRB of record and any other regulatory approvals, coordinate activities across participating sites, and manage participant accrual.
What does the notice say about institutional support?
Strong institutional support is expected as part of demonstrating readiness and capability to execute the clinical trial.
What if the project requires an FDA regulatory sponsor?
If the project requires an FDA regulatory sponsor, the application should show a commitment and capacity to fulfill sponsor responsibilities under 21 CFR 312, Subpart D.
What statistical materials must be included in the proposal?
The proposal should include a clear statistical analysis plan and a power analysis that justifies the sample size and demonstrates that the trial can answer its stated objectives.
Is a data management plan required?
Yes. A data management plan is required, including the use of an appropriate database to protect data integrity and security.
When is a 21 CFR Part 11-compliant database required?
If a Regulatory Agency requires it, the trial must use a database compliant with 21 CFR Part 11 and follow appropriate data standards suitable for regulatory review and high-confidence interpretation.
Who is offering this funding opportunity?
The opportunity is offered as a discretionary grant through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under the Department of Defense Multiple Sclerosis Research Program.
What is the official funding opportunity title and number?
The title is "DoD Multiple Sclerosis, Clinical Trial Award" and the opportunity number is HT942524MSRPCTA.
What is the CFDA number for this opportunity?
The CFDA number listed in the notice is 12.420.
Who is eligible to apply?
Eligibility is listed as unrestricted.
What is the application deadline?
The notice lists an original closing date of October 7, 2024.
How many awards does the notice anticipate making?
The notice anticipates making about three awards, indicating a competitive opportunity focused on well-justified, trial-ready proposals.
What is the overall goal of the CTA mechanism?
The overall goal is to support clinical trials that can start quickly and generate actionable findings with a realistic path to near-term clinical impact for people affected by MS.
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