DoD Spinal Cord Injury Clinical Trial Award Rehabilitation | Apply Online

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

1) What is the CTA-R funding opportunity?

The DoD Spinal Cord Injury Clinical Trial Award - Rehabilitation (CTA-R) is a funding mechanism under the Spinal Cord Injury Research Program (SCIRP) managed by the U.S. Army (USAMRAA). It is intended to move promising spinal cord injury (SCI) rehabilitation interventions into early-stage human testing quickly.

2) What types of clinical trials does CTA-R support?

This mechanism supports early-stage human clinical trials, specifically Phase 0, Phase I, or Phase II studies, focused on SCI rehabilitation interventions.

3) Does CTA-R fund preclinical or animal studies?

No. The CTA-R mechanism pays only for clinical trials in humans and does not fund preclinical, laboratory validation, or animal work.

4) How does the announcement define a "clinical trial"?

It uses a strict standard definition: a prospective human subjects study that enrolls people and tests an intervention to measure outcomes related to safety, feasibility, effectiveness, or efficacy.

5) What kinds of interventions can be studied under CTA-R?

The intervention can include a device, drug, biologic, surgical procedure, rehabilitative modality, behavioral program, or similar intervention, as long as it is tested prospectively in human subjects and aligned with SCI rehabilitation goals.

6) What outcomes or endpoints are most appropriate for this rehabilitation-focused award?

Proposed endpoints should clearly relate to rehabilitation-relevant outcomes such as functional recovery, independence, prevention of secondary complications, quality of life, or similar practical outcomes rather than basic science questions.

7) What is the overall purpose and expected impact of CTA-R studies?

The program aims to produce results that noticeably improve understanding of SCI and reduce real-world consequences, with emphasis on outcomes that matter to military Service members, veterans, and also caregivers and family members supporting them.

8) How quickly must an awarded clinical trial begin?

Trials are expected to start within 12 months of the award date, so applications should demonstrate operational readiness to move into recruitment and implementation quickly.

9) What level of supporting evidence is expected in an application?

Applications are expected to be grounded in a solid scientific rationale, supported by a critical review of the literature and relevant preliminary data.

10) What additional expectations apply to Phase II applications?

Phase II applications are expected to already have Phase I or pilot clinical trial data that justify scaling up to a larger study.

11) How important is recruitment feasibility and access to participants?

Recruitment feasibility is a major focus. Reviewers will look at whether the investigative team has access to an appropriate participant population and whether the recruitment plan is realistic for meeting accrual goals.

12) What methodological details are required in the trial design?

Applicants must define clear endpoints aligned with the study design and sample size, and include a clear statistical analysis plan. The announcement explicitly calls for appropriate statistical expertise and a power analysis supporting the proposed enrollment and demonstrating the study can address its primary objectives.

13) Does the program expect applicants to address controls and standards of care?

Yes. Reviewers will consider how controls will be used and how existing standards of care may affect eligibility, enrollment, and interpretation of what outcomes can be attributed to the intervention.

14) Are IND or IDE submissions required?

They may be required depending on the intervention. If an investigational drug is not FDA-approved for the proposed use, an IND may be required. If an investigational device is not approved or cleared for that clinical use, an IDE may be required.

15) When must an IND or IDE be submitted relative to the grant application?

When applicable, the IND or IDE must be submitted before the grant is submitted. This makes regulatory readiness a key pre-application planning item.

16) Can funding be withdrawn due to IND/IDE status issues after award?

Yes. Even after award, funding can be withdrawn if documented IND/IDE status is not obtained within 6 months of the award date.

17) Is local IRB approval required at the time of application submission?

No. Local IRB approval is not required at the time the application is submitted.

18) What human subjects oversight applies if the project is selected for funding?

If selected, the PI must submit a formal clinical protocol meeting U.S. Army Medical Research and Materiel Command human research requirements. In addition to local IRB review, the USAMRMC Human Research Protection Office (HRPO) must review and approve the work.

19) How long should applicants plan for HRPO review?

The announcement advises planning at least 4 months for HRPO review.

20) Is study coordinator support expected in the budget and staffing plan?

Yes. Applicants are expected to include study coordinator support to guide the protocol through IRB and HRPO/HSRRB processes, coordinate multi-site activities if relevant, and manage recruitment.

21) Does CTA-R encourage specific types of collaborations?

Yes. Partnerships between clinicians and bioengineers are explicitly encouraged, reflecting that many rehabilitation innovations blend clinical delivery with engineering, devices, or technology-enabled therapies.

22) Can trainees and early-career researchers be included?

Yes. The opportunity welcomes inclusion of trainees and early-career participants such as graduate students, medical students, residents, postdoctoral fellows, and clinician-scientists.

23) What is the Nested New Investigator Option?

The Nested New Investigator Option is a training add-on that allows one mentored new investigator to be included per proposal, with required documentation included in the application.

24) What documentation is required for the Nested New Investigator Option?

Required documentation includes the investigator's name, biosketch, a personal goals/commitment letter, and a mentor support letter.

25) Who is eligible to serve as the nested new investigator?

Eligibility includes trainees in mentored programs or clinicians who are new to research or new to SCI research, with limits intended to ensure the participant is genuinely early-stage in this area.

26) Are applicants expected to use standardized SCI data elements?

Yes. Applicants are expected to use SCI Common Data Elements (CDEs) developed with the International Spinal Cord Society, the American Spinal Injury Association, and NINDS to improve standardization and comparability across studies.

27) Can the government require data submission to a repository?

Yes. The government reserves the right to require data submission to designated repositories for archiving. Any submission-related costs are handled during award negotiations.

28) What is the Funding Opportunity Number for this CTA-R announcement?

The Funding Opportunity Number is W81XWH-11-SCIRP-CTA-R.

29) When was this opportunity posted and when did it close?

This FY11 opportunity was posted on June 1, 2011 and closed on December 1, 2011, with an archive date of December 31, 2011.

30) How many awards and how much total funding were anticipated?

It anticipated about three awards with an estimated total funding of $3.6 million.

31) Is cost sharing required?

No. The announcement stated that cost sharing was not required.

32) Who was eligible to apply?

Eligibility was listed as unrestricted, meaning it was open to any entity type, subject to any additional eligibility clarifications described in the full announcement.

33) What is the CFDA number associated with this program?

The award was listed under CFDA 12.420, Military Medical Research and Development.

34) What type of funding instrument is used and what does that imply?

The funding instrument was listed as a cooperative agreement/grant. This signals that DoD may expect a more collaborative level of program oversight than a typical research grant.

35) What kinds of projects are considered not ready for CTA-R?

Projects that are not ready for human accrual or that remain in lab validation stages are expected to apply through different SCIRP mechanisms rather than CTA-R.