Opportunity Information: Apply for W81XWH 13 TSCRP PCTA
Apply for W81XWH 13 TSCRP PCTA
- The Dept. of the Army USAMRAA in the regional development sector is offering a public funding opportunity titled "DoD Tuberous Sclerosis Research 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 3, 2013 and posted on May 3, 2013.
- Applicants must submit their applications by Jul 11, 2013. (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 Research Pilot Clinical Trial Award (FY13 TSCRP PCTA; Funding Opportunity Number W81XWH-13-TSCRP-PCTA) is a U.S. Department of Defense funding opportunity administered through the Department of the Army/USAMRAA under the Congressionally Directed Medical Research Programs (CDMRP). Its overall purpose is to move promising ideas closer to real-world impact for people living with tuberous sclerosis complex (TSC) by supporting early, well-justified clinical testing of interventions. The broader mission of the Tuberous Sclerosis Complex Research Program (TSCRP) is to stimulate innovative research that improves understanding of TSC pathogenesis and manifestations, ultimately improving patient outcomes and quality of life.
This mechanism is specifically designed to fund pilot clinical trials, meaning small, early-stage human studies intended to generate preliminary data that can justify, shape, and de-risk subsequent larger clinical trials. The emphasis is not on running a full-scale definitive trial, but on producing the kinds of data that help answer practical questions needed to launch the next phase of clinical development. The award supports studies of interventions that could materially improve treatment or management of TSC. Interventions can be broadly defined and may include drugs, biologics, devices, surgical procedures, rehabilitative approaches, behavioral interventions, or other strategies with a plausible clinical benefit for individuals with TSC.
The opportunity encourages proposals that align with one or more TSCRP Focus Areas, reflecting the diverse and multi-system nature of TSC. These focus areas include research on genetic, epigenetic, and non-genetic modifiers of disease; development and use of preclinical models and therapeutic strategies (including combination therapies and cytotoxic agents); and identification of biomarkers for early detection, prognosis, and prediction of treatment response, such as serum markers, imaging, electrophysiology, prenatal testing methods, and pharmacogenetic approaches. It also highlights adult manifestations of TSC, including care management questions, age-specific disease mechanisms, epidemiology, and complications affecting renal and reproductive health as well as lymphangioleiomyomatosis (LAM). Additional priority areas include understanding the long-term benefits and effects of mTOR inhibitors or other agents; creating new strategies for diagnosis, treatment, and prevention that emphasize early identification and early intervention; clarifying cellular and molecular mechanisms underlying TSC and LAM; and tackling major clinical burdens such as epilepsy and TSC-associated neurocognitive disorders (including cognitive impairment and psychiatric, behavioral, and sleep-related conditions).
In terms of the types of pilot clinical trial work the program aims to support, examples include studies that help identify the most appropriate patient population for an intervention, establish dosing, duration, and delivery methods, and test feasibility in the TSC community or clinical setting. The mechanism also supports early evaluations of efficacy and safety, including exploratory studies with limited human exposure that still yield meaningful diagnostic or therapeutic information. The announcement explicitly notes that pilot trials may include screening designs, microdose studies, toxicity studies, and studies focused on mechanism of action and side-effect profiles, as long as the work is positioned to inform the rationale and design of later-stage clinical trials.
From an administrative and funding standpoint, the award was offered as a discretionary funding opportunity using grant and cooperative agreement instruments, with no cost-sharing or matching requirement. The total estimated funding listed is $640,000 with an expectation of approximately two awards. The program is associated with CFDA number 12.420 (Military Medical Research and Development). Eligibility is described as unrestricted, meaning it is broadly open to a wide range of applicant organizations, subject to any clarifications contained in the full announcement. Key dates listed include a posted date of May 3, 2013 and an application closing date of July 11, 2013 (with the opportunity later archived on August 10, 2013). For applicant support, the CDMRP Help Desk is provided as the primary point of contact for accessing the full announcement and troubleshooting submission issues.
FAQs: DoD Tuberous Sclerosis Research Pilot Clinical Trial Award (FY13 TSCRP PCTA)
What is the FY13 TSCRP Pilot Clinical Trial Award?
It is a U.S. Department of Defense (DoD) funding opportunity called the Tuberous Sclerosis Research Pilot Clinical Trial Award (FY13 TSCRP PCTA), Funding Opportunity Number W81XWH-13-TSCRP-PCTA. It is administered through the Department of the Army/USAMRAA under the Congressionally Directed Medical Research Programs (CDMRP).
What is the overall purpose of this award?
The overall purpose is to move promising ideas closer to real-world impact for people living with tuberous sclerosis complex (TSC) by supporting early, well-justified clinical testing of interventions. The program is intended to generate the kinds of preliminary human data needed to justify and design subsequent larger clinical trials.
How does this award fit into the broader TSCRP mission?
The broader mission of the Tuberous Sclerosis Complex Research Program (TSCRP) is to stimulate innovative research that improves understanding of TSC pathogenesis and manifestations, with the goal of improving patient outcomes and quality of life.
Is this award meant to fund a full-scale, definitive clinical trial?
No. This mechanism is specifically designed for pilot clinical trials, which are small, early-stage human studies intended to produce preliminary data that can shape, justify, and de-risk later, larger trials. The emphasis is on practical early clinical development questions rather than a definitive, full-scale trial.
What kinds of studies are considered "pilot clinical trials" under this opportunity?
Pilot clinical trials under this opportunity are early-stage human studies that may focus on questions such as identifying the appropriate patient population, establishing dosing, determining duration and delivery methods, and demonstrating feasibility in the TSC community or clinical setting. The program also supports early evaluations of efficacy and safety intended to inform the design of future, later-stage trials.
What types of interventions can be studied?
Interventions are defined broadly and may include drugs, biologics, devices, surgical procedures, rehabilitative approaches, behavioral interventions, or other strategies with a plausible clinical benefit for individuals with TSC.
What is the program looking for in terms of impact for people with TSC?
The funded pilot clinical trial work is intended to support interventions that could materially improve treatment or management of TSC, producing early human data that helps move the intervention toward later-stage clinical development.
Do proposed projects need to align with TSCRP Focus Areas?
The opportunity encourages proposals that align with one or more TSCRP Focus Areas. These focus areas reflect the diverse and multi-system nature of TSC and include multiple clinical and translational priorities described in the announcement summary.
What Focus Areas related to modifiers of disease are included?
Focus areas include research on genetic, epigenetic, and non-genetic modifiers of disease.
What Focus Areas relate to preclinical models and therapeutic strategy development?
The announcement highlights development and use of preclinical models and therapeutic strategies, including combination therapies and cytotoxic agents.
What biomarker-related Focus Areas are mentioned?
The opportunity includes identification of biomarkers for early detection, prognosis, and prediction of treatment response. Examples cited include serum markers, imaging, electrophysiology, prenatal testing methods, and pharmacogenetic approaches.
Does the opportunity include adult manifestations of TSC as a priority?
Yes. It highlights adult manifestations of TSC, including care management questions, age-specific disease mechanisms, epidemiology, and complications affecting renal and reproductive health as well as lymphangioleiomyomatosis (LAM).
Are mTOR inhibitors specifically mentioned as an area of interest?
Yes. The announcement highlights understanding the long-term benefits and effects of mTOR inhibitors or other agents.
Does the program emphasize early identification and early intervention?
Yes. It includes creating new strategies for diagnosis, treatment, and prevention that emphasize early identification and early intervention.
Are cellular and molecular mechanisms of TSC and LAM included?
Yes. Clarifying cellular and molecular mechanisms underlying TSC and LAM is included among the priority areas described.
Are neurological and neurocognitive burdens like epilepsy included?
Yes. The opportunity calls out major clinical burdens such as epilepsy and TSC-associated neurocognitive disorders, including cognitive impairment and psychiatric, behavioral, and sleep-related conditions.
What are examples of specific pilot trial designs mentioned?
The announcement explicitly notes that pilot trials may include screening designs, microdose studies, toxicity studies, and studies focused on mechanism of action and side-effect profiles, as long as they are positioned to inform the rationale and design of later-stage clinical trials.
Does the award support feasibility work in the TSC community or clinical setting?
Yes. The program lists feasibility testing in the TSC community or clinical setting as an example of the types of pilot clinical trial work it aims to support.
Does the opportunity allow early evaluations of efficacy and safety?
Yes. It supports early evaluations of efficacy and safety, including exploratory studies with limited human exposure, provided they yield meaningful diagnostic or therapeutic information that informs future trials.
Is the funding opportunity a grant, a cooperative agreement, or both?
It was offered as a discretionary funding opportunity using grant and cooperative agreement instruments.
Is cost-sharing or matching required?
No. The opportunity specifies that there is no cost-sharing or matching requirement.
How much total funding was estimated for this opportunity?
The total estimated funding listed is $640,000.
How many awards were expected?
The opportunity indicated an expectation of approximately two awards.
What is the CFDA number associated with this program?
The program is associated with CFDA number 12.420, Military Medical Research and Development.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to a wide range of applicant organizations, subject to any clarifications contained in the full announcement.
What is the funding opportunity number?
The Funding Opportunity Number is W81XWH-13-TSCRP-PCTA.
When was the opportunity posted, and what was the closing date?
The posted date is listed as May 3, 2013, and the application closing date is listed as July 11, 2013.
Was this opportunity later archived?
Yes. The opportunity is described as having been archived on August 10, 2013.
Who administers this funding opportunity?
It is administered through the Department of the Army/USAMRAA under the CDMRP.
Where can applicants get help accessing the full announcement or troubleshooting submission issues?
The CDMRP Help Desk is provided as the primary point of contact for accessing the full announcement and troubleshooting submission issues.
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