Opportunity Information: Apply for W81XWH 11 TSCRP CTA
Apply for W81XWH 11 TSCRP 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 FY11 Tuberous Sclerosis Complex 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, 2011 and posted on May 3, 2011.
- Applicants must submit their applications by Aug 4, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 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 FY11 Tuberous Sclerosis Complex (TSC) Clinical Trial Award is a U.S. Department of Defense funding opportunity run through the Tuberous Sclerosis Complex Research Program (TSCRP), a program created in 2002 to stimulate innovative research aimed at reducing the real-world clinical burden of TSC. The overall purpose of the program is to push forward new, practical knowledge about how TSC develops (its pathogenesis) and to move those insights into better care for people living with the condition. Within that larger mission, this specific award mechanism is designed to fund clinical trials that could meaningfully change how TSC is treated or managed, rather than early-stage or laboratory-only work.
A key feature of this opportunity is that the award money must be used to conduct a clinical trial and cannot be spent on preclinical studies. The announcement uses a clear, traditional definition of a clinical trial: it must involve prospective enrollment of human participants and test an intervention in people to measure outcomes tied to exploratory findings, safety, effectiveness, and/or efficacy. The intervention can take many forms, including a drug, biologic, medical device, surgery, rehabilitation approach, behavioral intervention, or another type of clinical interaction, but the measurable outcome must reflect a direct effect of that intervention on the human subject. In other words, proposals need to be built around a real, forward-looking human study with defined endpoints, not preparatory animal work, bench science, or purely observational data collection.
Administratively, the opportunity was offered as either a cooperative agreement or a grant under the broad category of science and technology research and development, with oversight through the Department of the Army (USAMRAA). The government anticipated making one award, with an estimated total funding amount of $1,500,000, and it did not require cost sharing or matching funds from applicants. Eligibility was described as unrestricted, meaning it was generally open to any type of applicant organization as long as it met any additional eligibility details that might have been included in the full announcement text.
For timing, the funding opportunity (W81XWH 11 TSCRP CTA) was posted on May 3, 2011, and closed on August 4, 2011, with the archive date listed as September 3, 2011. The CFDA listing associated with it was 12.420 (Military Medical Research and Development). Applicants needing help accessing the full announcement were directed to the CDMRP help desk (PA HELP and eReceipt HELP) at 301-682-5507.
Frequently Asked Questions (FAQs): DOD FY11 Tuberous Sclerosis Complex (TSC) Clinical Trial Award
What is the DOD FY11 Tuberous Sclerosis Complex (TSC) Clinical Trial Award?
The DOD FY11 Tuberous Sclerosis Complex (TSC) Clinical Trial Award is a U.S. Department of Defense funding opportunity offered through the Tuberous Sclerosis Complex Research Program (TSCRP). It is specifically intended to support clinical trials in tuberous sclerosis complex that could meaningfully change how TSC is treated or managed.
Which organization runs this funding opportunity?
The opportunity is run through the Department of Defense TSCRP, with oversight through the Department of the Army (USAMRAA).
What is the TSCRP and why was it created?
The Tuberous Sclerosis Complex Research Program (TSCRP) was created in 2002 to stimulate innovative research aimed at reducing the real-world clinical burden of TSC. Its broader mission is to advance practical knowledge about how TSC develops (pathogenesis) and translate those insights into better care for people living with the condition.
What is the main purpose of this specific award mechanism?
This award mechanism is designed to fund clinical trials, not early-stage or laboratory-only work. The focus is on human studies that can produce results capable of meaningfully influencing clinical practice for TSC treatment or management.
Does this award require that the funded work be a clinical trial?
Yes. A key feature of this opportunity is that award funds must be used to conduct a clinical trial. The funds cannot be used for preclinical studies.
Are preclinical studies allowed under this award?
No. The announcement explicitly states that award money cannot be spent on preclinical studies.
How does this opportunity define a "clinical trial"?
The opportunity uses a traditional definition of a clinical trial: it must involve prospective enrollment of human participants and must test an intervention in people. Outcomes must be measured in relation to exploratory findings, safety, effectiveness, and/or efficacy.
Does the clinical trial need to be prospective?
Yes. The definition provided requires prospective enrollment of human subjects.
What kinds of interventions can be tested in the clinical trial?
The intervention can take many forms, including (but not limited to) a drug, biologic, medical device, surgery, rehabilitation approach, behavioral intervention, or another type of clinical interaction, as long as it is tested in people and outcomes are measured.
What kind of outcomes does the trial need to measure?
The outcomes must reflect a direct effect of the tested intervention on the human subject and be tied to exploratory findings, safety, effectiveness, and/or efficacy.
Are observational studies or data collection without an intervention eligible?
The opportunity emphasizes that proposals must be built around a real, forward-looking human study that tests an intervention with defined endpoints, rather than purely observational data collection.
Is bench science or laboratory-only work a fit for this award?
No. The opportunity is positioned for clinical trials that could change treatment or management of TSC, rather than laboratory-only or preparatory work.
What funding instrument(s) were used for this opportunity?
Administratively, the opportunity was offered as either a cooperative agreement or a grant within the broad category of science and technology research and development.
How many awards did the government anticipate making?
The government anticipated making one award.
What was the estimated total funding amount?
The estimated total funding amount was $1,500,000.
Is cost sharing or matching funds required?
No. The opportunity did not require cost sharing or matching funds.
Who was eligible to apply?
Eligibility was described as unrestricted, meaning it was generally open to any type of applicant organization, as long as it met any additional eligibility details that might have been included in the full announcement.
What is the opportunity identification or reference number?
The opportunity is identified as W81XWH 11 TSCRP CTA.
What is the CFDA number associated with this funding opportunity?
The CFDA listing associated with the opportunity is 12.420 (Military Medical Research and Development).
When was the opportunity posted?
The funding opportunity was posted on May 3, 2011.
When did the application period close?
The opportunity closed on August 4, 2011.
When was the opportunity archived?
The archive date listed for the opportunity is September 3, 2011.
Where could applicants get help accessing the full announcement?
Applicants needing help accessing the full announcement were directed to the CDMRP help desk (PA HELP and eReceipt HELP) at 301-682-5507.
What is the overall program goal that this clinical trial award supports?
Within the TSCRP mission, this award supports research intended to move insights about TSC pathogenesis into better clinical care, specifically by funding interventional human clinical trials with measurable outcomes.
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