Opportunity Information: Apply for W81XWH 10 SCIRP CTA R

  • 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 Spinal Cord Injury Clinical Trial Award Rehabilitation" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
  • This funding opportunity was created on Jun 18, 2010 and posted on Jun 18, 2010.
  • Applicants must submit their applications by Dec 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $11,250,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:

The DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation (CTA-R) is a funding opportunity run through the Department of the Army (USAMRAA) under the Spinal Cord Injury Research Program (SCIRP). Its purpose is to speed the launch of early-stage human clinical trials that test rehabilitation-focused interventions for spinal cord injury (SCI). The award is specifically aimed at Phase 0, Phase I, or Phase II trials that could meaningfully improve understanding of SCI and reduce its long-term consequences through rehabilitation approaches. A central requirement is that the work must be relevant to the healthcare needs of the Armed Forces, their family members, and/or the U.S. veteran population, which shapes the kinds of study questions and settings that are likely to be considered responsive.

This mechanism is strictly for clinical trials in humans, defined here as prospective enrollment of participants in which an intervention is tested with measurable safety and/or efficacy outcomes and informed consent is required. Because it is a clinical trial award, studies may involve identifiable information and must follow human-subjects protections and regulatory oversight. Preclinical work is not allowed under this funding line, meaning no in vitro studies and no animal research can be supported with CTA-R funds. Investigators who want to pursue preclinical development are directed to other SCIRP mechanisms rather than trying to fit that work into this program.

Applications are expected to be trial-ready and built around a concrete clinical protocol. Investigators have to clearly state what type of clinical trial they are proposing and identify the phase and, when relevant, the device classification. The program is designed for rapid execution: the proposed clinical trial is expected to start within 12 months of the award date. Review expectations emphasize practical feasibility and rigorous design, including clear evidence that the team can recruit an appropriate SCI patient population in sufficient numbers to generate meaningful results, whether at one site or across multiple sites.

In terms of what makes a strong application, the announcement highlights several recurring elements. The trial must have an unmistakable rehabilitation focus within SCI, not a general SCI intervention without a rehab-centered rationale and outcomes. The endpoints need to be well defined and tightly aligned with the trial design and the planned sample size, rather than broad or exploratory goals that do not match what the study is powered to detect. A detailed statistical analysis plan is required, along with appropriate statistical expertise and a power analysis that justifies enrollment targets and supports the study objectives. Applicants are also expected to explain why the results would matter for people living with SCI, in other words, how the findings could change practice, inform future trials, or directly improve functional outcomes and quality of life.

Operationally, the DoD places heavy weight on regulatory readiness and coordinated trial management. Applications are expected to include a study coordinator responsible for shepherding the protocol through Institutional Review Board (IRB) review, the Human Subjects Research Review Board (HSRRB) and other required approvals, coordinating multi-site activities if applicable, and managing participant accrual. If the intervention requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), those approvals should be initiated or completed before submission. The program also sets a firm expectation after award: if IND or IDE approval is not obtained within six months of the award date, the government may revoke the funding, which effectively makes regulatory planning and timelines a critical risk area that applicants have to address credibly.

Another key requirement is a Transition Plan that explains what happens after the award period ends, such as how the project will advance to the next level of testing, broader implementation, a later-phase clinical trial, or other adoption pathways. The opportunity also expects the Principal Investigator to demonstrate real clinical expertise relevant to SCI rehabilitation, reflecting that this is not a basic research mechanism but an applied clinical testing program. Collaboration is encouraged, especially partnerships between clinicians and bioengineers, which fits many rehabilitation technologies and intervention approaches. The program also encourages training and career development by involving graduate and medical students, residents, postdoctoral fellows, and clinician-scientists as part of the project team.

For FY10, the announcement adds a Nested New Investigator Option aimed at bringing new people into SCI research through mentored involvement embedded within a larger clinical trial application. Only one nested new investigator can be included per proposal, and the application must provide the individual’s name, biosketch, and a letter describing professional goals and commitment to SCI research, along with a mentor letter of support. Eligibility for the nested role includes trainees (graduate students, medical students, residents, postdoctoral fellows) in mentored programs, clinicians who are new to scientific research and have not held independent research funding in any discipline, or clinicians who have research experience but are new to the SCI field and lack independent funding or publications in SCI research specifically. The intent is to ensure the trainee’s role is substantive and productive, not just nominal, and that they receive meaningful mentorship in SCI rehabilitation research.

From the posted grant metadata, the opportunity is listed as Funding Opportunity Number W81XWH-10-SCIRP-CTA-R, categorized as discretionary funding and offered as a cooperative agreement grant under CFDA 12.420 (Military Medical Research and Development). It was posted June 18, 2010, with an application closing date of December 1, 2010, and an estimated total program funding level of $11.25 million with an expectation of about three awards. Cost sharing is not required, and eligibility is described as unrestricted (open broadly to entity types), subject to any additional eligibility clarifications in the full announcement. Contact support is provided through the CDMRP help channels for application and electronic submission assistance.

FAQs: DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation (CTA-R)

What is the DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation (CTA-R)?

The CTA-R is a Department of Defense funding opportunity managed through the Department of the Army (USAMRAA) under the Spinal Cord Injury Research Program (SCIRP). It is intended to accelerate early-stage human clinical trials that test rehabilitation-focused interventions for spinal cord injury (SCI).

What is the main purpose of this award?

The purpose is to speed the launch of early-stage clinical trials in humans that can improve understanding of SCI and reduce long-term consequences through rehabilitation approaches.

What clinical trial phases are supported?

This mechanism is specifically aimed at Phase 0, Phase I, or Phase II clinical trials.

Is this funding only for human clinical trials?

Yes. This award mechanism is strictly for clinical trials in humans, defined as prospective enrollment of participants where an intervention is tested with measurable safety and/or efficacy outcomes and informed consent is required.

Are observational or non-interventional human studies allowed?

The opportunity is described as a clinical trial award focused on testing an intervention with measurable safety and/or efficacy outcomes. Based on the information provided, the program is intended for interventional clinical trials rather than purely observational work.

Is preclinical research allowed (animal studies or in vitro studies)?

No. Preclinical work is not allowed under CTA-R funding. This includes in vitro studies and animal research.

If my project includes both preclinical and clinical work, can I submit under CTA-R?

CTA-R funds cannot be used to support preclinical work. The opportunity notes that investigators seeking preclinical development should use other SCIRP mechanisms rather than trying to fit that work into this program.

What kinds of interventions are appropriate under CTA-R?

Interventions must have an unmistakable rehabilitation focus within SCI. The program is not intended for general SCI interventions without a rehabilitation-centered rationale and outcomes.

How important is military or veteran relevance?

It is a central requirement. The work must be relevant to the healthcare needs of the Armed Forces, their family members, and/or the U.S. veteran population. This requirement influences which study questions, populations, and settings are considered responsive.

What does "trial-ready" mean for this opportunity?

Applications are expected to be built around a concrete clinical protocol and be ready to execute rapidly. The proposed clinical trial is expected to start within 12 months of the award date.

Do applicants need to state the trial phase and type?

Yes. Investigators must clearly state what type of clinical trial is proposed and identify the phase. When relevant, applicants must also identify the device classification.

What are the expectations for study endpoints?

Endpoints must be well defined and tightly aligned with the trial design and planned sample size. The announcement emphasizes avoiding broad or exploratory goals that do not match what the study is powered to detect.

Is a statistical analysis plan required?

Yes. A detailed statistical analysis plan is required, along with appropriate statistical expertise.

Is a power analysis required?

Yes. Applicants must include a power analysis that justifies enrollment targets and supports the study objectives.

What does the program expect regarding participant recruitment?

Review expectations emphasize feasibility and rigorous design, including clear evidence that the team can recruit an appropriate SCI patient population in sufficient numbers to generate meaningful results, whether at a single site or across multiple sites.

Can trials be multi-site?

Yes. The information provided contemplates either single-site or multi-site recruitment and notes that applications should address coordination of multi-site activities if applicable.

What human subjects and regulatory oversight requirements apply?

Because this is a human clinical trial mechanism, studies may involve identifiable information and must follow human-subjects protections and regulatory oversight, including institutional review processes.

What approvals are mentioned for human subjects review?

The opportunity references Institutional Review Board (IRB) review and the Human Subjects Research Review Board (HSRRB), along with other required approvals as applicable.

Is a study coordinator required?

The opportunity expects inclusion of a study coordinator responsible for managing key trial operations, including shepherding the protocol through IRB/HSRRB and other approvals, coordinating multi-site activities (if applicable), and managing participant accrual.

What is expected regarding IND or IDE approvals?

If the intervention requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), those approvals should be initiated or completed before submission.

What happens if IND or IDE approval is delayed after award?

The program sets a firm expectation: if IND or IDE approval is not obtained within six months of the award date, the government may revoke the funding. This makes regulatory planning and timelines a critical risk area to address.

How soon must the clinical trial start after award?

The proposed clinical trial is expected to start within 12 months of the award date.

What is a Transition Plan, and is it required?

A Transition Plan is required. It should explain what happens after the award period ends, such as how the project will advance to the next level of testing, broader implementation, a later-phase clinical trial, or other adoption pathways.

What expertise is expected from the Principal Investigator (PI)?

The PI is expected to demonstrate real clinical expertise relevant to SCI rehabilitation, reflecting that this is an applied clinical testing program rather than a basic research mechanism.

Are collaborations encouraged?

Yes. Collaboration is encouraged, including partnerships between clinicians and bioengineers, which is consistent with many rehabilitation technologies and intervention approaches.

Does the opportunity encourage training or career development roles on the team?

Yes. The program encourages involving graduate and medical students, residents, postdoctoral fellows, and clinician-scientists as part of the project team.

What is the FY10 Nested New Investigator Option?

For FY10, the announcement includes a Nested New Investigator Option designed to bring new investigators into SCI research through mentored involvement embedded within a larger clinical trial application.

How many nested new investigators can be included per proposal?

Only one nested new investigator can be included per proposal.

What documentation is required for the nested new investigator?

The application must provide the individual’s name and biosketch, a letter describing professional goals and commitment to SCI research, and a mentor letter of support.

Who is eligible to be a nested new investigator?

Eligibility includes: trainees (graduate students, medical students, residents, postdoctoral fellows) in mentored programs; clinicians new to scientific research who have not held independent research funding in any discipline; or clinicians with research experience who are new to the SCI field and lack independent funding or publications in SCI research specifically.

What is the expectation for the nested new investigator's role?

The nested investigator role is expected to be substantive and productive, not nominal, and the individual is expected to receive meaningful mentorship in SCI rehabilitation research.

What is the Funding Opportunity Number for this program?

The Funding Opportunity Number listed is W81XWH-10-SCIRP-CTA-R.

What type of funding mechanism is this?

It is listed as discretionary funding and offered as a cooperative agreement grant.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA 12.420 (Military Medical Research and Development).

When was this opportunity posted, and what was the application deadline?

It was posted on June 18, 2010, and the application closing date was December 1, 2010.

How much funding is expected to be available, and how many awards are anticipated?

The estimated total program funding level is $11.25 million, with an expectation of about three awards.

Is cost sharing required?

No. Cost sharing is not required.

Who is eligible to apply?

Eligibility is described as unrestricted (open broadly to entity types), subject to any additional eligibility clarifications in the full announcement.

Where can applicants get help with the application or electronic submission?

Contact support is provided through the CDMRP help channels for application and electronic submission assistance.

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