Spinal Cord Injury Research Program Clinical Trial Award Rehabilitation | Apply Online

FAQs: SCIRP Clinical Trial Award - Rehabilitation (CTA-R)

1) What is the SCIRP Clinical Trial Award - Rehabilitation (CTA-R)?

The SCIRP Clinical Trial Award - Rehabilitation (CTA-R) is a Department of Defense (DOD) funding opportunity intended to move quickly from planning into execution of human clinical trials that could meaningfully improve outcomes for people living with spinal cord injury (SCI). The focus is on rehabilitation-oriented approaches that deepen understanding of SCI and reduce real-world consequences through practical, patient-centered interventions.

2) What is the central purpose of this funding opportunity?

The central purpose is to support well-defined, implementable human clinical trials that have the potential to produce high-impact results for rehabilitation after SCI, including results that could change rehabilitation practice or improve patient outcomes.

3) Who is the funding agency?

The opportunity is offered by the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA), under the Department of Defense.

4) What is the Funding Opportunity Number for this award?

The Funding Opportunity Number is W81XWH-09-SCIRP-CTA-R.

5) What type of funding instrument is used?

The opportunity uses a cooperative agreement/grant within the science and technology research and development category.

6) Is this opportunity only for clinical trials?

Yes. This mechanism is strictly for human clinical trials. It is not intended for preclinical research or animal studies.

7) Are preclinical or animal studies allowed under CTA-R?

No. Applicants proposing preclinical work are directed to other SCIRP mechanisms rather than CTA-R.

8) What phases of clinical trials are eligible?

Applicants must clearly state the type of clinical trial being proposed, such as Phase 0, Phase I, Phase II, Phase III, or a combination of phases.

9) How quickly is the trial expected to start after award?

The program emphasizes speed to launch. The proposed trial is expected to begin within 12 months of the award date, so applications should reflect that sites, staffing, and operational planning are mature enough to start quickly.

10) What does the DOD mean by a "well-defined, implementable clinical protocol"?

Based on the opportunity description, the trial must be presented as a clear clinical protocol that can be executed in practice, rather than a concept that still needs major design development. This includes clearly described endpoints, enrollment targets, operational readiness, and a statistical plan that matches the design.

11) What population focus or relevance is required?

A key requirement is relevance to the health care needs of military service members, their family members, and/or the U.S. veteran population. Proposals need to make a clear case that the intervention and the problems being targeted align with those communities.

12) Does the opportunity require evidence of feasibility?

Yes. Applications are expected to show that the trial is feasible and adequately powered, not just scientifically interesting.

13) What does "adequately powered" mean in the context of this announcement?

The opportunity expects a power analysis that justifies the sample size and demonstrates the study can decisively address its primary objectives, with endpoints that match the design and planned enrollment.

14) What are the expectations around patient access and recruitment?

Applicants are expected to demonstrate access to an appropriate patient population large enough to produce meaningful, interpretable results. Recruitment and accrual are treated as operational priorities, and the application should reflect readiness to enroll participants.

15) Are broad or exploratory endpoints acceptable?

The opportunity emphasizes clearly defined and focused endpoints that match the study design and proposed sample size. It cautions against broad or exploratory aims that would not be answered by the planned enrollment.

16) Is a statistical analysis plan required?

Yes. The protocol must include a detailed statistical analysis plan along with a power analysis supporting the sample size.

17) What level of impact is the program looking for?

The DOD is looking for potentially high-impact rehabilitation trials. Applicants are expected to explain why results would matter to people with SCI and how the findings could change rehabilitation practice or patient outcomes.

18) What human-subjects oversight should applicants plan for?

Because this is human subjects research, regulatory readiness is treated as a core element. In addition to local Institutional Review Board (IRB) review, DOD-funded studies involving human subjects or human biological substances must be reviewed by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO).

19) How much time should be planned for regulatory review and approvals?

The announcement cautions applicants to plan for these steps, with at least six months set aside for regulatory review and approvals due to DOD-specific rigor and documentation requirements.

20) Is a study coordinator required or strongly expected?

Applications should include a dedicated study coordinator responsible for navigating IRB and other approvals, coordinating work across participating sites, and managing participant recruitment and accrual.

21) What if the trial involves a regulated product?

For trials involving regulated products, the announcement sets strong expectations around FDA-related clearances. If an Investigational New Drug (IND) application is relevant, it should be initiated or completed before submission. If an Investigational Device Exemption (IDE) is needed, the proposal should show that the pathway is already underway and that the timeline is realistic.

22) What is the consequence of not obtaining IND/IDE approval by the stated deadline?

The announcement states that failure to obtain IND/IDE approval by June 30, 2010 can result in the Government revoking funding.

23) Are multi-institutional or multi-site clinical trials allowed?

Yes. Multi-institutional trials are allowed and may be advantageous, but they come with additional planning requirements.

24) What additional plans are needed for multi-institutional trials?

Applications must spell out how collaborating institutions will communicate and transfer data. They must also describe how specimens and/or imaging products will be handled across sites.

25) Is an intellectual and material property plan required for multi-site efforts?

Yes. Multi-site efforts require a separate intellectual and material property plan agreed upon by all participating institutions, indicating ownership, sharing, and use rights should be resolved upfront.

26) Does the opportunity encourage collaboration with DOD researchers or clinicians?

Yes. The opportunity encourages alignment and collaboration with existing DOD research efforts and military clinicians or researchers, suggesting applicants position their trial within broader DOD priorities and leverage relevant networks where possible.

27) What related DOD or federal resources are referenced as helpful context?

The opportunity references resources for understanding related work and areas of interest, including CDMRP, DTIC, the Army Medical Research and Materiel Command, service research labs, DARPA, and the Department of Veterans Affairs research enterprise.

28) How many awards were anticipated?

The program anticipated making about 4 awards.

29) What was the estimated total funding amount?

The estimated total funding amount was $9.6 million.

30) Is cost sharing or matching required?

No. The opportunity indicated no cost sharing or matching requirement.

31) Who is eligible to apply?

Eligibility is described as unrestricted (open to any type of entity), subject to details in the full announcement.

32) When was the announcement posted?

The announcement was posted on July 13, 2009.

33) What was the application deadline?

The application deadline was December 10, 2009.

34) What was the archive date?

The archive date was January 9, 2010.

35) Where can applicants get help with accessing the announcement or submission issues?

The notice provides contact points for assistance accessing the announcement and for eReceipt/CDMRP help desk issues.