Opportunity Information: Apply for W81XWH 14 TSCRP PCTA
Apply for W81XWH 14 TSCRP PCTA
- 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 Tuberous Sclerosis Complex Pilot 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 May 28, 2014 and posted on May 27, 2014.
- Applicants must submit their applications by Jul 24, 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 $640,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 Tuberous Sclerosis Complex Pilot Clinical Trial Award (TSCRP PCTA; Funding Opportunity Number W81XWH-14-TSCRP-PCTA) is a Department of the Army/USAMRAA funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) that supports early, exploratory clinical studies in tuberous sclerosis complex (TSC). The intent is to generate practical, decision-making human data using limited participant exposure, so researchers can refine and de-risk future, larger clinical trials. In other words, the program is looking for pilot-stage clinical work that can quickly answer key questions about diagnostics or interventions, produce preliminary signals of benefit or safety, and help establish the right biomarkers and endpoints to measure meaningful improvement in TSC outcomes.
The award mechanism is specifically aimed at small, hypothesis-driven clinical studies such as screening or microdose studies, focused toxicity evaluations, and trials designed to clarify an intervention’s mechanism of action and side-effect profile. The emphasis is on obtaining preliminary clinical information that can move the field toward better interventions and better ways to measure whether those interventions are working. Typical projects include identifying the most appropriate patient population to study (for example, defining eligibility criteria that capture the subgroup most likely to respond), establishing the right dose, duration, and/or delivery strategy, testing whether a proposed intervention is feasible to implement in the TSC setting, and generating early evidence related to efficacy and safety. Overall, the program is positioned as a bridge between basic or preclinical work and full-scale clinical testing, with deliverables that make subsequent trials more rigorous and more likely to succeed.
Because these projects involve clinical testing in humans, regulatory readiness is a central requirement. If a proposed clinical trial uses a drug that is not already approved by the U.S. Food and Drug Administration (FDA) for the specific investigational use being proposed, an Investigational New Drug (IND) submission that complies with 21 CFR 312 may be required, and it must be submitted to the FDA before the grant application deadline. Similarly, if the investigational product is a medical device, applicants must provide evidence that an Investigational Device Exemption (IDE) submission meeting 21 CFR 812 has been filed with the FDA before the application deadline, or provide documentation that the device is IDE-exempt. Beyond submission, applicants must also secure and provide documentation of IND or IDE approval prior to programmatic review by sending it to the CDMRP Help Desk (help@eBRAP.org). If that approval documentation is not provided in time, the government reserves the right to withdraw the application, which effectively makes regulatory planning and timelines a make-or-break element of competitiveness and eligibility.
From a funding and administrative standpoint, this opportunity was offered as a discretionary program using a cooperative agreement grant mechanism, indicating that the funder may anticipate substantial involvement or oversight consistent with cooperative agreements. The expected number of awards was two, with an estimated total funding amount of $640,000 and no cost sharing or matching requirement. Eligibility was listed as unrestricted, meaning a wide range of organizations could apply (subject to any additional clarifications in the full announcement). The opportunity was posted May 27, 2014, and the application deadline was July 24, 2014 (with the archive date listed as August 23, 2014). The CFDA listing associated with this program is 12.420, Military Medical Research and Development. For applicants needing assistance accessing the full announcement or navigating submission, the contact point provided is the CDMRP Help Desk (phone 301-682-5507; email help@eBRAP.org).
In practical terms, the TSCRP Pilot Clinical Trial Award is best suited for teams that already have a strong rationale for a diagnostic or therapeutic approach in TSC and need focused human data to determine whether it is worth scaling up. Competitive applications would be expected to present a tight clinical question, a realistic pilot design with clear safety monitoring and measurable endpoints, and a credible plan for producing data that can directly inform next-step clinical development, including biomarker strategy and future trial design. Regulatory compliance is not a box-checking exercise here; the program explicitly requires timely FDA submission and approval documentation when IND/IDE pathways apply, reinforcing that proposals must be operationally ready to proceed on the timelines typical of a pilot clinical effort.
FAQs: DoD Tuberous Sclerosis Complex Pilot Clinical Trial Award (TSCRP PCTA)
What is the TSCRP Pilot Clinical Trial Award (PCTA)?
The TSCRP Pilot Clinical Trial Award (PCTA) is a Department of Defense (DoD) funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP), administered by the Department of the Army/USAMRAA. It supports early, exploratory clinical studies in tuberous sclerosis complex (TSC) designed to generate practical, decision-making data in humans with limited participant exposure.
What is the main goal of this funding opportunity?
The main goal is to produce preliminary human data that helps refine and de-risk future, larger clinical trials in TSC. Projects are expected to quickly answer key questions about diagnostics or interventions, generate early signals of benefit or safety, and help define appropriate biomarkers and endpoints for meaningful outcomes.
What types of clinical studies does this award support?
The award is aimed at small, hypothesis-driven clinical studies, including screening or microdose studies, focused toxicity evaluations, and trials intended to clarify an intervention's mechanism of action and side-effect profile.
Is this award intended for large, definitive clinical trials?
No. The intent is pilot-stage clinical work that provides early, decision-making information to inform later, full-scale clinical testing.
What kinds of deliverables are expected from a pilot clinical trial under this program?
Expected deliverables include preliminary evidence related to efficacy and safety, information that supports choosing the right patient population, and data to support decisions about dose, duration, delivery strategy, feasibility in a TSC setting, and selection of biomarkers and endpoints for subsequent trials.
How does the program describe the role of pilot studies in the TSC development pipeline?
The program is positioned as a bridge between basic or preclinical work and full-scale clinical testing. The purpose is to make later trials more rigorous and more likely to succeed by generating operationally useful human data early.
What does "limited participant exposure" mean in this context?
It means the program favors designs that minimize how many participants are exposed and/or the degree of exposure while still producing practical clinical information needed to make next-step development decisions.
What is meant by "practical, decision-making human data"?
It refers to human clinical data that can directly inform go/no-go decisions and trial design choices for future studies, such as whether an intervention shows enough promise, what safety signals appear, and what endpoints and biomarkers are most appropriate.
Are biomarkers and endpoints a priority in this opportunity?
Yes. The opportunity explicitly emphasizes establishing the right biomarkers and endpoints to measure meaningful improvement in TSC outcomes and to guide future trial design.
What kinds of questions should a competitive pilot trial be designed to answer?
Competitive projects would be expected to focus on a tight clinical question and generate data that can clarify feasibility, mechanism of action, side-effect profile, dosing approach (dose/duration/delivery), appropriate eligibility criteria, and early evidence related to safety and efficacy.
What is the funding mechanism for this opportunity?
This opportunity was offered as a discretionary program using a cooperative agreement grant mechanism, which indicates the funder may anticipate substantial involvement or oversight consistent with cooperative agreements.
How many awards were expected and what was the total estimated funding?
The expected number of awards was two, with an estimated total funding amount of $640,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility was listed as unrestricted, meaning a wide range of organizations could apply (subject to any additional clarifications in the full announcement).
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is W81XWH-14-TSCRP-PCTA.
What is the CFDA number associated with this program?
The CFDA listing associated with this program is 12.420, Military Medical Research and Development.
When was this opportunity posted and when were applications due?
The opportunity was posted May 27, 2014, and the application deadline was July 24, 2014. The archive date is listed as August 23, 2014.
What regulatory requirements apply to studies funded under this award?
Because the projects involve clinical testing in humans, regulatory readiness is a central requirement. If the trial uses a drug not already approved by the FDA for the specific investigational use proposed, an IND submission that complies with 21 CFR 312 may be required. If the investigational product is a medical device, evidence of an IDE submission meeting 21 CFR 812 must be provided before the application deadline, or documentation that the device is IDE-exempt must be provided.
When must an IND be submitted to the FDA, if required?
If an IND is required, it must be submitted to the FDA before the grant application deadline.
When must an IDE be filed, if required?
If an IDE is required, applicants must provide evidence that the IDE submission has been filed with the FDA before the application deadline, or provide documentation that the device is IDE-exempt.
Is FDA approval documentation required in addition to FDA submission?
Yes. Applicants must secure and provide documentation of IND or IDE approval prior to programmatic review by sending it to the CDMRP Help Desk (help@eBRAP.org).
Where should IND/IDE approval documentation be sent?
Approval documentation must be provided to the CDMRP Help Desk at help@eBRAP.org.
What happens if IND/IDE approval documentation is not provided in time?
If approval documentation is not provided prior to programmatic review, the government reserves the right to withdraw the application.
Why is regulatory planning described as critical for this award?
The program explicitly requires timely FDA submission (when applicable) before the application deadline and requires IND/IDE approval documentation before programmatic review, making regulatory timelines a key factor that can affect competitiveness and continued consideration of the application.
What is the best fit for this award in terms of project readiness?
This award is best suited for teams with a strong rationale for a diagnostic or therapeutic approach in TSC that are operationally ready to proceed and need focused human data to determine whether the approach should be scaled up into larger clinical trials.
What support contact is listed for applicants who need help?
Applicants can contact the CDMRP Help Desk for assistance accessing the full announcement or navigating submission. Phone: 301-682-5507. Email: help@eBRAP.org.
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