Opportunity Information: Apply for W81XWH 14 SCIRP CTA
Apply for W81XWH 14 SCIRP CTA
- 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" 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 4, 2014 and posted on Jun 4, 2014.
- Applicants must submit their applications by Oct 30, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $9,600,000.00 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 (SCIRP CTA; Funding Opportunity Number W81XWH 14 SCIRP CTA) is a Congressionally Directed Medical Research Programs opportunity managed by the Department of the Army (USAMRAA) to fund human clinical trials aimed at improving the treatment or management of spinal cord injury (SCI) and related complications, with particular relevance to military Service Members and Veterans (though the research may include other affected individuals as well). This mechanism is specifically intended to move promising interventions forward in people, not in the lab: award funds must be used to run a clinical trial and cannot support preclinical or animal studies. The program defines a clinical trial in the standard prospective way, meaning the study must enroll human participants and test an intervention (such as a drug, device, biologic, surgical approach, rehabilitation method, behavioral intervention, or similar) with measurable outcomes tied to safety, effectiveness, efficacy, or exploratory clinical information.
A key theme of the award is readiness and real-world impact. Applicants are expected to propose an intervention with clear potential to meaningfully affect the lives of people living with SCI and its downstream consequences, and the trial is expected to start quickly, no later than 6 months after the award date. Applications must include preliminary data that directly supports the proposed trial, along with a strong scientific rationale grounded in critical review of existing literature. The application should also address the intended clinical use of the product or intervention: if a label indication is relevant (for example, for a drug or device), the applicant should describe the planned indication and outline the development steps needed to support it, showing that the clinical trial fits into a credible path toward the next phase of testing and/or eventual clinical adoption.
Because the funded work involves regulated clinical research, the opportunity places heavy emphasis on FDA and Good Clinical Practice expectations. If the study uses a drug that is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) submission to FDA may be required under 21 CFR 312, and it must be submitted before the grant application deadline. If the study involves a device, applicants must provide evidence that an Investigational Device Exemption (IDE) submission meeting 21 CFR 812 has been made prior to the deadline, or documentation that the device is IDE-exempt. Beyond submission, the program requires that documentation of IND or IDE approval be provided to the CDMRP Help Desk prior to Programmatic Review; if that approval is not provided in time, the government can withdraw the application from consideration.
The program is also very specific about what a strong clinical trial plan must include. Applicants need to demonstrate access to a suitable patient population and make a convincing case that enrollment targets are realistic, including how accrual goals will be met and how existing standards of care could affect recruitment, comparators, or outcomes. They must also show documented access to the intervention materials (drug, compound, device, or other necessary resources) and indicate that product quality and manufacturing controls are appropriate for the type and stage of development, aligned with applicable FDA expectations such as Good Manufacturing Practices and, for devices, Quality System Regulation standards. On study design, the trial must have clear, appropriate endpoints, follow GCP guidelines, and include rigorous operational planning: a statistical analysis plan, statistical expertise, and a power analysis that justifies the sample size and demonstrates the study can answer its primary objectives. In parallel, the application must lay out a data management plan (including an appropriate database and safeguards for data integrity), a safety management plan (including pharmacovigilance when applicable), and a clinical monitoring plan describing how compliance and trial quality will be overseen.
Operational capability and institutional backing are treated as essential, not optional. The application is expected to include a study coordinator (or coordinators) who can manage regulatory approvals such as IRB review, coordinate multi-site activities when relevant, and drive participant recruitment and retention. The application must also show strong institutional support, signaling that the organization has the infrastructure and commitment to execute a regulated clinical trial on schedule. In addition, applicants must commit to registering the study on ClinicalTrials.gov, reflecting federal expectations for transparency in human research.
Another notable requirement is standardization and data sharing readiness. Applicants are expected to use the spinal cord injury Common Data Elements (CDEs) developed through the International Spinal Cord Society, the American Spinal Injury Association, and the National Institute of Neurological Disorders and Stroke CDE team. The government also reserves the right to designate data repositories for archiving, with any repository submission costs addressed during award negotiations. Finally, the award requires a Transition Plan describing what happens after the SCIRP-funded trial ends, including likely funding sources and resources to move the product to the next clinical phase and/or toward market delivery if the trial is successful, reinforcing that the program is designed to catalyze real, downstream clinical implementation rather than stand-alone academic findings.
From an administrative standpoint, this was a discretionary funding opportunity offering assistance via cooperative agreement and grant mechanisms, categorized under science and technology research and development (CFDA 12.420, Military Medical Research and Development). The posting date was June 4, 2014, with an original and current closing date of October 30, 2014, and an archive date of November 29, 2014. The opportunity anticipated making about 3 awards with an estimated total funding level of $9.6 million, did not require cost sharing, and listed eligibility as unrestricted (open to any entity type, subject to any clarifications in the full announcement). For support, the announcement directs applicants to the CDMRP Help Desk (help@eBRAP.org; 301-682-5507) and references additional human-subjects guidance through eBRAP.
DoD Spinal Cord Injury Clinical Trial Award (SCIRP CTA) - FAQs
What is the DoD Spinal Cord Injury Clinical Trial Award (SCIRP CTA)?
The SCIRP Clinical Trial Award is a Congressionally Directed Medical Research Programs (CDMRP) funding opportunity managed by the Department of the Army (USAMRAA) to support human clinical trials intended to improve the treatment or management of spinal cord injury (SCI) and related complications.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is W81XWH 14 SCIRP CTA.
What kind of research does this award fund?
This award funds human clinical trials that prospectively enroll participants and test an intervention with measurable outcomes related to safety, effectiveness, efficacy, and/or exploratory clinical information.
Are preclinical, animal, or laboratory studies allowed under this award?
No. Award funds must be used to run a clinical trial in people and cannot support preclinical or animal studies.
What counts as an intervention for the purposes of this clinical trial award?
Interventions may include, for example, a drug, device, biologic, surgical approach, rehabilitation method, behavioral intervention, or a similar approach, as long as it is tested in humans with measurable clinical outcomes.
Is the program focused only on military populations?
The opportunity emphasizes particular relevance to military Service Members and Veterans, but the research may include other affected individuals as well.
How quickly must the clinical trial begin after award?
The trial is expected to start quickly, no later than 6 months after the award date.
Is preliminary data required to apply?
Yes. Applications must include preliminary data that directly supports the proposed trial.
What level of scientific rationale is expected in the application?
The application is expected to provide a strong scientific rationale supported by preliminary data and grounded in a critical review of existing literature.
Does the application need to address eventual clinical use or product indication?
Yes. The application should describe the intended clinical use of the product or intervention. If a label indication is relevant (for example, for a drug or device), the applicant should describe the planned indication and outline development steps needed to support it, showing how the trial fits into a credible path toward the next testing phase and/or clinical adoption.
What FDA regulatory expectations apply to this opportunity?
The opportunity places heavy emphasis on FDA and Good Clinical Practice (GCP) expectations and requires documentation consistent with regulated clinical research when applicable (for example, IND/IDE-related submissions and approvals).
When is an Investigational New Drug (IND) submission required?
If the study uses a drug that is not FDA-approved for the proposed investigational use, an IND submission to FDA may be required under 21 CFR 312, and it must be submitted before the grant application deadline.
When is an Investigational Device Exemption (IDE) submission required?
If the study involves a device, applicants must provide evidence that an IDE submission meeting 21 CFR 812 has been made prior to the application deadline, or provide documentation that the device is IDE-exempt.
Is IND or IDE approval required, or just submission?
The opportunity requires that documentation of IND or IDE approval be provided to the CDMRP Help Desk prior to Programmatic Review. If that approval is not provided in time, the government can withdraw the application from consideration.
Where must IND/IDE approval documentation be sent?
Documentation of IND or IDE approval must be provided to the CDMRP Help Desk prior to Programmatic Review.
What happens if IND/IDE approval documentation is not provided on time?
If IND or IDE approval is not provided to the CDMRP Help Desk prior to Programmatic Review, the government can withdraw the application from consideration.
What does the program expect regarding patient population and enrollment feasibility?
Applicants must demonstrate access to a suitable patient population and provide a convincing case that enrollment targets are realistic, including how accrual goals will be met and how existing standards of care could affect recruitment, comparators, or outcomes.
Do applicants need documented access to the intervention materials?
Yes. The application must show documented access to the intervention materials (such as a drug, compound, device, or other required resources).
Are manufacturing and product quality expectations addressed in this award?
Yes. Applicants must indicate that product quality and manufacturing controls are appropriate for the type and stage of development and aligned with applicable FDA expectations, such as Good Manufacturing Practices (and for devices, Quality System Regulation standards).
What trial design elements are emphasized as required?
The trial must have clear, appropriate endpoints, follow GCP guidelines, and include rigorous operational planning, including a statistical analysis plan, statistical expertise, and a power analysis that justifies the sample size and demonstrates the study can answer its primary objectives.
Are data management plans required?
Yes. The application must include a data management plan, including an appropriate database and safeguards for data integrity.
Are safety and monitoring plans required?
Yes. The application must include a safety management plan (including pharmacovigilance when applicable) and a clinical monitoring plan describing how compliance and trial quality will be overseen.
Is a study coordinator required?
The application is expected to include a study coordinator (or coordinators) who can manage regulatory approvals such as IRB review, coordinate multi-site activities when relevant, and drive participant recruitment and retention.
How important is institutional support for this award?
Institutional support is treated as essential. The application must show strong institutional support demonstrating the organization has the infrastructure and commitment to execute a regulated clinical trial on schedule.
Is ClinicalTrials.gov registration required?
Yes. Applicants must commit to registering the study on ClinicalTrials.gov.
Are there standardization requirements for SCI data collection?
Yes. Applicants are expected to use spinal cord injury Common Data Elements (CDEs) developed through the International Spinal Cord Society, the American Spinal Injury Association, and the National Institute of Neurological Disorders and Stroke CDE team.
Does the government require data sharing or repository submission?
The government reserves the right to designate data repositories for archiving. Any repository submission costs are to be addressed during award negotiations.
Is a Transition Plan required, and what should it cover?
Yes. The award requires a Transition Plan describing what happens after the SCIRP-funded trial ends, including likely funding sources and resources to move the product to the next clinical phase and/or toward market delivery if the trial is successful.
What type of funding mechanism is used for this opportunity?
This was a discretionary funding opportunity offering assistance via cooperative agreement and grant mechanisms.
What is the CFDA number and program category for this opportunity?
The opportunity is categorized under science and technology research and development with CFDA 12.420, Military Medical Research and Development.
When was this opportunity posted, and what were the key dates?
It was posted on June 4, 2014. The original and current closing date was October 30, 2014, and the archive date was November 29, 2014.
How many awards were anticipated and what was the estimated total funding?
The opportunity anticipated making about 3 awards with an estimated total funding level of $9.6 million.
Was cost sharing required?
No. The opportunity did not require cost sharing.
Who was eligible to apply?
Eligibility was listed as unrestricted (open to any entity type), subject to any clarifications in the full announcement.
Who should applicants contact for help or questions?
Applicants are directed to the CDMRP Help Desk at help@eBRAP.org or 301-682-5507, with additional human-subjects guidance referenced through eBRAP.
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