Opportunity Information: Apply for W81XWH 22 TSCRP CTRA
The Department of Defense, through the U.S. Army Medical Research Acquisition Activity (USAMRAA), offered the Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Translational Research Award (CTRA) under Funding Opportunity Number W81XWH 22 TSCRP CTRA. This opportunity is designed to fund research that takes strong, well-supported findings from preclinical and/or clinical work and pushes them closer to real-world clinical use for tuberous sclerosis complex (TSC). In practical terms, the emphasis is on translational momentum: projects should be positioned to meaningfully advance how TSC is diagnosed, how outcomes are predicted (prognosis), or how the condition is treated.
The award mechanism is meant to support studies that bridge the gap between laboratory and clinic in either direction. That includes moving promising preclinical discoveries toward early clinical evaluation, or using clinical observations to refine and redirect preclinical models and hypotheses. A major eligible area described in the announcement is the use of human anatomical substances (for example, patient-derived specimens) and/or analysis of data connected to completed clinical trials. The solicitation explicitly points to correlative and retrospective-type studies that leverage existing trial datasets to explore relationships between genetic and/or environmental factors and disease progression, or to examine how an intervention influenced disease outcomes. In other words, it is not limited to running new trials; it also supports deeper analyses that can extract clinically useful signals from prior human research efforts.
Another central focus is improving clinical trial readiness, especially by building the tools needed to run informative and efficient trials in TSC. The opportunity highlights development of biomarkers, the identification and refinement of clinical endpoints, and validation of pharmacokinetics and pharmacodynamics (PK/PD). These components are often the difference between a concept that looks promising on paper and a program that is truly ready for clinical testing, since biomarkers and endpoints determine whether a trial can reliably measure benefit, and PK/PD work helps establish how an intervention behaves in the body and whether it is engaging its intended target.
The announcement also allows for pilot clinical trials when limited human testing is necessary to decide what comes next in the translational pipeline. These pilots are characterized as small, early studies (for example, limited sample sizes) intended to generate the kind of initial safety, feasibility, dosing, or preliminary activity data that can justify and shape a larger follow-on study. The key idea is that the clinical testing should be purposeful and positioned to inform the next step, rather than being a standalone trial without a clear downstream plan.
From an administrative standpoint, the opportunity was listed as discretionary funding and could be awarded as either a cooperative agreement or a grant, indicating the Department of Defense could support projects with varying degrees of agency involvement depending on the instrument used. The activity category is Science and Technology and other Research and Development, with CFDA number 12.420. Eligibility was described as unrestricted, meaning it was broadly open to different types of applicant organizations, with the caveat that applicants would still need to follow any clarifications included in the full eligibility text of the official announcement. The posting date (creation date) was March 31, 2022, with an original closing date of July 28, 2022, and the program anticipated making two awards. The public listing shows an award ceiling of 0, which typically signals that the maximum funding level was not specified in that particular summary field and would need to be confirmed in the full funding announcement or accompanying program guidance.
Overall, this grant opportunity is aimed at translationally focused TSC research that is mature enough to move the needle toward clinical application, whether by converting strong preclinical evidence into human testing, extracting new clinical insights from existing human samples and trial data, developing the biomarkers and endpoints needed for future trials, or conducting carefully scoped pilot trials that de-risk and guide the next phase of development.Apply for W81XWH 22 TSCRP CTRA
- The Department of Defense, 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 Research Program, Clinical Translational Research Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Mar 31, 2022.
- Applicants must submit their applications by Jul 28, 2022. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
This opportunity is the Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Translational Research Award (CTRA).
Which agency is offering this funding opportunity?
The Department of Defense (DoD) is offering the opportunity through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number listed is W81XWH 22 TSCRP CTRA.
What is the overall purpose of the TSCRP Clinical Translational Research Award?
The purpose is to fund research that takes strong, well-supported findings from preclinical and/or clinical work and pushes them closer to real-world clinical use for tuberous sclerosis complex (TSC). The emphasis is on projects with clear translational momentum that can meaningfully advance diagnosis, prognosis, or treatment of TSC.
What types of research are emphasized under this award?
The award emphasizes translational research positioned to move toward clinical application. Examples described include bridging lab and clinic in either direction (preclinical to clinical, or clinical observations back to preclinical models), leveraging human specimens and existing clinical trial data, improving clinical trial readiness tools, and conducting limited pilot clinical trials when needed to inform next steps.
How does this award define "translational" work in practice?
Translational work here means bridging the gap between laboratory and clinical settings. This can include moving promising preclinical discoveries into early clinical evaluation, or using clinical observations to refine and redirect preclinical models and hypotheses so they better reflect human disease and inform future clinical development.
Does the opportunity support studies using human specimens?
Yes. A major eligible area described is the use of human anatomical substances, such as patient-derived specimens.
Does the opportunity support analysis of data from completed clinical trials?
Yes. The solicitation explicitly points to analysis of data connected to completed clinical trials, including correlative and retrospective-type studies that leverage existing trial datasets.
What kinds of questions can retrospective or correlative studies address under this award?
Examples described include exploring relationships between genetic and/or environmental factors and disease progression, and examining how an intervention influenced disease outcomes using existing datasets from completed clinical trials.
Is funding limited to proposing new clinical trials?
No. The description states it is not limited to running new trials and also supports deeper analyses that extract clinically useful signals from prior human research efforts (including existing samples and completed trial data).
What does the opportunity say about clinical trial readiness?
Improving clinical trial readiness is a central focus. The opportunity highlights building tools needed to run informative and efficient trials in TSC.
What trial-readiness tools are specifically highlighted?
The opportunity highlights development of biomarkers, identification and refinement of clinical endpoints, and validation of pharmacokinetics and pharmacodynamics (PK/PD).
Why are biomarkers and clinical endpoints important in the context of this award?
According to the description, biomarkers and endpoints are often critical for making trials informative and efficient because they determine whether a trial can reliably measure benefit. They can be the difference between a promising concept and a program that is ready for clinical testing.
What does PK/PD mean, and why is it included?
PK/PD refers to pharmacokinetics and pharmacodynamics. The opportunity includes PK/PD validation because it helps establish how an intervention behaves in the body and whether it is engaging its intended target.
Are pilot clinical trials allowed under this award?
Yes. The announcement allows for pilot clinical trials when limited human testing is necessary to decide what comes next in the translational pipeline.
What is meant by a "pilot clinical trial" in this opportunity?
Pilot clinical trials are characterized as small, early studies (for example, limited sample sizes) intended to generate initial safety, feasibility, dosing, or preliminary activity data that can justify and shape a larger follow-on study.
What is the expectation for pilot clinical trials proposed under this award?
The clinical testing should be purposeful and positioned to inform the next step in development, rather than being a standalone trial without a clear downstream plan.
What funding type is this opportunity described as?
It was listed as discretionary funding.
What award instruments may be used for this opportunity?
The opportunity could be awarded as either a cooperative agreement or a grant, indicating the DoD could support projects with varying degrees of agency involvement depending on the instrument used.
What is the activity category for this opportunity?
The activity category is Science and Technology and other Research and Development.
What is the CFDA number associated with this program?
The CFDA number listed is 12.420.
Who is eligible to apply?
Eligibility was described as unrestricted, meaning it was broadly open to different types of applicant organizations. The description notes that applicants would still need to follow any clarifications included in the full eligibility text of the official announcement.
When was the opportunity posted?
The posting (creation) date shown is March 31, 2022.
What was the original closing date?
The original closing date listed is July 28, 2022.
How many awards were anticipated?
The program anticipated making two awards.
What is the award ceiling for this opportunity?
The public listing shows an award ceiling of 0, which typically indicates the maximum funding level was not specified in that summary field and would need to be confirmed in the full funding announcement or accompanying program guidance.
What kinds of TSC impacts are projects expected to advance?
Projects should be positioned to meaningfully advance how TSC is diagnosed, how outcomes are predicted (prognosis), or how the condition is treated.
What is the general theme of the opportunity in one sentence?
This opportunity targets translationally focused TSC research mature enough to move toward clinical application, whether through human-sample or trial-data analyses, biomarker/endpoint/PK-PD development for trial readiness, or carefully scoped pilot clinical trials that de-risk and guide the next phase.
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| DOD, Tuberous Sclerosis Complex Research Program, Idea Development Award Apply for W81XWH 22 TSCRP IDA Funding Number: W81XWH 22 TSCRP IDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DOD, Tuberous Sclerosis Complex Research Program, Exploration – Hypothesis Development Award Apply for W81XWH 22 TSCRP EHDA Funding Number: W81XWH 22 TSCRP EHDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Impact Award Apply for W81XWH 22 PRCRP IPA Funding Number: W81XWH 22 PRCRP IPA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Convergent Science Cancer Consortium Development Award Apply for W81XWH 22 PRCRP CSCCDA Funding Number: W81XWH 22 PRCRP CSCCDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Behavioral Health Science Award Apply for W81XWH 22 PRCRP BHSA Funding Number: W81XWH 22 PRCRP BHSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Translational Team Science Award Apply for W81XWH 22 PRCRP TTSA Funding Number: W81XWH 22 PRCRP TTSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Career Development Award Apply for W81XWH 22 PRCRP CDA Funding Number: W81XWH 22 PRCRP CDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed, Idea Award Apply for W81XWH 22 PRCRP IA Funding Number: W81XWH 22 PRCRP IA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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| DoD Prostate Cancer, Exploration-Hypothesis Development Award Apply for W81XWH 22 PCRP EHDA Funding Number: W81XWH 22 PCRP EHDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Idea Development Award Apply for W81XWH 22 PCRP IDA Funding Number: W81XWH 22 PCRP IDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Early Investigator Research Award Apply for W81XWH 22 PCRP EIRA Funding Number: W81XWH 22 PCRP EIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Translational Science Award Apply for W81XWH 22 PCRP TSA Funding Number: W81XWH 22 PCRP TSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Data Science Award Apply for W81XWH 22 PCRP DSA Funding Number: W81XWH 22 PCRP DSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Physician Research Award Apply for W81XWH 22 PCRP PRA Funding Number: W81XWH 22 PCRP PRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Health Disparity Research Award Apply for W81XWH 22 PCRP HDRA Funding Number: W81XWH 22 PCRP HDRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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