Opportunity Information: Apply for W81XWH 16 TSCRP PCTA
Apply for W81XWH 16 TSCRP PCTA
- The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "FY16 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.
- This funding opportunity was created on May 09, 2016 and posted on May 09, 2016.
- Applicants must submit their applications by Jul 18, 2016. (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 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 FY16 Tuberous Sclerosis Complex Pilot Clinical Trial Award (PCTA) is a Department of Defense (DOD) Tuberous Sclerosis Complex Research Program funding opportunity designed specifically to support early, exploratory clinical trials in people with tuberous sclerosis complex (TSC). The purpose is to generate preliminary human data that can move a diagnostic or therapeutic intervention forward, especially by clarifying whether an approach looks promising enough, safe enough, and practical enough to justify larger, definitive trials. The mechanism is explicitly meant for studies with limited human exposure, such as small sample sizes, and it focuses on producing actionable signals around effectiveness, safety, tolerability, and/or mechanism of action in humans.
A central requirement is that the proposed work must be a pilot clinical trial, not preclinical research. Under this announcement, a clinical trial is defined in a very straightforward way: a prospective study where patients are enrolled and an intervention is tested in human subjects, with measurable outcomes that reflect a direct effect of that intervention or interaction. The intervention can take many forms, including a drug, device, biologic, surgical procedure, rehabilitation modality, behavioral intervention, or other clinical approach, as long as it is tested prospectively in humans and produces data relevant to safety, efficacy, effectiveness, or exploratory clinical questions. Because of this focus, applications proposing animal studies, bench experiments, or other preclinical-only development efforts are not considered responsive and should instead be routed to other TSCRP award mechanisms (for example, the Exploration-Hypothesis Development Award, Idea Development Award, or Synergistic Idea Development Award referenced in the notice).
The announcement highlights several kinds of studies that fit well within the PCTA scope. These include studies that help identify which patient population or subpopulation is most appropriate for later-stage trials, which is particularly relevant in TSC given its clinical variability. It also includes projects aimed at working out practical clinical details such as dosage, treatment duration, or delivery strategy, as well as studies that test whether an intervention is feasible to implement in a TSC setting (recruitment, adherence, outcome measurement, site logistics, and related real-world constraints). Finally, it supports pilot evaluations of efficacy and safety, meaning the trial can be designed to look for early signs of benefit while also characterizing risks and tolerability in the intended population.
There are also clear regulatory expectations for studies involving investigational products. If the trial uses a drug that is not FDA-approved for the proposed investigational use, the applicant must provide evidence that an Investigational New Drug (IND) application meeting 21 CFR 312 requirements has been submitted to the FDA before the application deadline, or that the product is exempt from IND requirements. If the investigational product is a device, the same concept applies through an Investigational Device Exemption (IDE) under 21 CFR 812, again requiring evidence of submission or exemption prior to the application deadline. The application must include the TSCRP IND/IDE Documentation Form (Attachment 8), and the program further requires that documentation showing IND/IDE approval or exemption be provided by 5:00 p.m. ET on November 1, 2016; otherwise, the government reserves the right to withdraw the application.
From an administrative standpoint, this opportunity was posted May 9, 2016, with an application closing date of July 18, 2016. It is listed under Funding Opportunity Number W81XWH-16-TSCRP-PCTA and is offered by DOD-AMRAA. The funding instruments indicated include grants and cooperative agreements, and eligibility is described as unrestricted (open to any type of entity, subject to any additional clarifications in the full announcement). The CFDA number associated with the opportunity is 12.420. The listing also indicates an expectation of one award, while the award ceiling is not specified in the provided source data.
Overall, the PCTA is best understood as targeted seed funding for human-centered, early clinical testing in TSC, with an emphasis on generating credible preliminary evidence that can de-risk and shape subsequent larger clinical trials. It prioritizes direct patient involvement, measurable outcomes, and compliance with FDA investigational requirements when applicable, while drawing a hard line against using these funds for preclinical studies.
Frequently Asked Questions (FAQs) - FY16 Tuberous Sclerosis Complex Pilot Clinical Trial Award (PCTA)
What is the FY16 Tuberous Sclerosis Complex Pilot Clinical Trial Award (PCTA)?
The FY16 Tuberous Sclerosis Complex Pilot Clinical Trial Award (PCTA) is a Department of Defense (DOD) Tuberous Sclerosis Complex Research Program (TSCRP) funding opportunity intended to support early, exploratory clinical trials in people with tuberous sclerosis complex (TSC).
What is the main purpose of this award?
The purpose is to generate preliminary human data that can move a diagnostic or therapeutic intervention forward. This includes helping determine whether an approach appears promising, safe, and practical enough to justify larger, more definitive clinical trials.
Is this award meant for large clinical trials?
No. This mechanism is explicitly meant for pilot clinical trials with limited human exposure, such as small sample sizes, designed to generate actionable early signals rather than definitive evidence.
What kinds of results is the PCTA designed to produce?
The award focuses on producing actionable signals related to effectiveness, safety, tolerability, and/or mechanism of action in humans.
Does the proposed work have to be a clinical trial?
Yes. A central requirement is that the proposed work must be a pilot clinical trial and not preclinical research.
How does this opportunity define a "clinical trial"?
Under this announcement, a clinical trial is defined as a prospective study where patients are enrolled and an intervention is tested in human subjects, with measurable outcomes reflecting a direct effect of the intervention or interaction.
What types of interventions can be tested under this award?
The intervention can include a drug, device, biologic, surgical procedure, rehabilitation modality, behavioral intervention, or another clinical approach, as long as it is tested prospectively in humans and produces measurable outcomes relevant to safety, efficacy, effectiveness, or exploratory clinical questions.
Are preclinical studies (animal or bench research) allowed under the PCTA?
No. Applications proposing animal studies, bench experiments, or other preclinical-only development efforts are not considered responsive under this announcement.
If my work is preclinical, what should I do instead?
The announcement indicates that preclinical-only efforts should be routed to other TSCRP award mechanisms, such as the Exploration-Hypothesis Development Award, Idea Development Award, or Synergistic Idea Development Award (as referenced in the notice).
What types of pilot clinical trial questions fit well within the PCTA scope?
Examples highlighted in the announcement include studies that: identify the most appropriate patient population or subpopulation for later trials; refine clinical details like dosage, treatment duration, or delivery strategy; test feasibility of implementing the intervention in a TSC setting (recruitment, adherence, outcome measurement, site logistics); and conduct pilot evaluations of efficacy and safety.
Can the trial focus on identifying which TSC subpopulation to enroll in later studies?
Yes. The announcement specifically notes that studies aimed at identifying the most appropriate patient population or subpopulation are a strong fit, which can be particularly important in TSC due to clinical variability.
Can this award be used to determine dosage, treatment duration, or delivery strategy?
Yes. The PCTA supports projects aimed at working out practical clinical details such as dosage, treatment duration, or delivery strategy.
Is feasibility testing an acceptable goal for a pilot trial under this award?
Yes. The scope includes testing feasibility in real-world TSC clinical settings, including recruitment, adherence, outcome measurement, and site logistics.
Does the PCTA allow pilot evaluations of efficacy and safety?
Yes. The announcement supports pilot evaluations designed to look for early signs of benefit while also characterizing risks, safety, and tolerability in the intended population.
What are the FDA regulatory expectations if the study uses an investigational drug?
If the trial uses a drug that is not FDA-approved for the proposed investigational use, the applicant must provide evidence that an Investigational New Drug (IND) application meeting 21 CFR 312 requirements has been submitted to the FDA before the application deadline, or that the product is exempt from IND requirements.
What are the FDA regulatory expectations if the study uses an investigational device?
If the investigational product is a device, the applicant must provide evidence that an Investigational Device Exemption (IDE) under 21 CFR 812 has been submitted to the FDA before the application deadline, or that the device is exempt from IDE requirements.
Is specific IND/IDE paperwork required in the application?
Yes. The application must include the TSCRP IND/IDE Documentation Form (Attachment 8).
When must evidence of IND/IDE submission or exemption be in place?
The announcement requires evidence that an IND or IDE has been submitted to the FDA (or that the product is exempt) before the application deadline.
Is there a separate deadline for providing IND/IDE approval or exemption documentation?
Yes. Documentation showing IND/IDE approval or exemption must be provided by 5:00 p.m. ET on November 1, 2016. If it is not provided by that time, the government reserves the right to withdraw the application.
Who is offering this funding opportunity?
The opportunity is offered by DOD-AMRAA under the Department of Defense (DOD) Tuberous Sclerosis Complex Research Program (TSCRP).
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is W81XWH-16-TSCRP-PCTA.
When was this opportunity posted and when did it close?
It was posted on May 9, 2016, and the application closing date was July 18, 2016.
What types of funding instruments are used for this award?
The listing indicates that the funding instruments include grants and cooperative agreements.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is open to any type of entity (subject to any additional clarifications in the full announcement).
What is the CFDA number associated with this opportunity?
The CFDA number associated with the opportunity is 12.420.
How many awards are expected?
The listing indicates an expectation of one award.
Is the maximum award amount (award ceiling) provided?
No. The award ceiling is not specified in the provided source data.
In plain terms, what is this award best used for?
This award is best understood as targeted seed funding for human-centered, early clinical testing in TSC, intended to generate credible preliminary evidence that can de-risk and shape later, larger clinical trials.
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