DoD Neurofibromatosis, Clinical Trial Award | W81XWH 22 NFRP CTA

Frequently Asked Questions (FAQs): DoD Neurofibromatosis Research Program (NFRP) Clinical Trial Award

What is the DoD NFRP Clinical Trial Award intended to fund?

This funding opportunity is intended to speed up the launch and execution of clinical trials that could meaningfully improve the treatment or day-to-day management of neurofibromatosis (NF). The emphasis is on studies expected to make a real difference for patients, either by testing something new or by strengthening the evidence base for approaches already emerging in the field.

Is this opportunity specifically for clinical trials?

Yes. This mechanism is specifically for clinical trials, and the funded work must involve human subjects receiving an intervention under a prospective assignment design.

Does the proposed work have to involve human subjects?

Yes. The opportunity is built around interventional human subjects research. Projects must involve human subjects receiving an intervention with prospective assignment.

What does "prospective assignment" mean in the context of this award?

Based on the listing, the award requires a clinical trial design where human subjects are assigned prospectively to receive an intervention. In other words, the study is structured in advance to assign participants to an intervention as part of the trial.

What kinds of clinical trials are supported (early-stage vs. later-stage)?

A wide range of trial types and stages are supported, from early feasibility efforts to larger, more definitive studies. On the early end, the award supports proof-of-concept or exploratory trials, including pilot studies, first-in-human studies, and phase 0 work. On the later end, it supports larger trials intended to determine efficacy in relevant NF patient populations.

Are pilot studies and exploratory trials allowed under this award?

Yes. The opportunity explicitly allows proof-of-concept or exploratory clinical trials, such as pilot studies, first-in-human studies, and phase 0 work designed to show feasibility, identify signals of activity, refine endpoints, and inform later-phase trial structure.

Are larger efficacy trials allowed under this award?

Yes. The opportunity allows for larger trials intended to determine efficacy in relevant NF patient populations.

What is the main goal or emphasis of the program?

The central goal is rapid implementation of clinical testing and a meaningful impact on NF care. The program emphasizes trials positioned to improve treatment or management in ways that matter to patients, and it prioritizes readiness to move into active clinical testing rather than earlier-stage laboratory or preparatory work.

What types of interventions can be evaluated?

The award supports evaluation of interventions such as pharmacologic agents (including drugs and biologics), medical devices, clinical guidance or care strategies, and newer approaches or technologies that could change how NF is treated or managed, as long as the project is structured as a clinical trial.

Can the intervention be a drug, biologic, or medical device?

Yes. Pharmacologic agents (including drugs and biologics) and medical devices are specifically listed as examples of interventions that may be evaluated.

Can the intervention be a care strategy or clinical guidance approach rather than a product?

Yes. The announcement indicates that clinical guidance or care strategies may be evaluated, provided the project is a clinical trial and is positioned to significantly impact NF care.

Does the program fund preclinical research?

No. The announcement explicitly signals that investigators whose work is preclinical should pursue other NFRP funding announcements instead of this one. This award is intended for active clinical testing rather than preclinical or purely preparatory research.

How "ready" does a project need to be to apply?

The opportunity emphasizes rapid implementation, meaning applicants should be ready to move into an active clinical testing phase. Proposals focused on preclinical work or purely preparatory research are not aligned with the intent described in the listing.

What funding instruments may be used for this opportunity?

The opportunity uses either a grant or a cooperative agreement as the funding instrument, under the Department of Defense (Department of the Army, U.S. Army Medical Research Acquisition Activity, USAMRAA).

Which agency and office are associated with administering this award?

The opportunity is associated with the Department of Defense, Department of the Army, and specifically references the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the funding opportunity title and number?

The funding opportunity title is "DoD Neurofibromatosis, Clinical Trial Award" and the opportunity number is W81XWH 22 NFRP CTA.

What is the CFDA number associated with this opportunity?

The listing associates this opportunity with CFDA number 12.420.

What kind of funding category does this opportunity fall under?

It is categorized as discretionary funding in the science and technology / research and development space.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is broadly open to many entity types, subject to any additional eligibility clarifications that may be included in the full announcement text.

How many awards are expected?

The source listing shows an expected number of awards as 1.

What is the award ceiling for this opportunity?

The award ceiling is displayed as 0 in the source data. This typically indicates the ceiling may be defined elsewhere in the full program announcement or handled through programmatic budgeting rather than a simple fixed cap in the listing.

What are the key dates shown in the source listing?

The creation date shown is April 11, 2022, and the original closing date shown is July 21, 2022.

What compliance requirements are highlighted for human subjects research?

The program highlights human subjects protections and references a specific Human Research Protections Office resource document for applicants to consult. Proposals are expected to align with ethical, regulatory, and oversight requirements typical of interventional human subjects research.

What aspects of an application are likely to receive close scrutiny during review?

Because the award is explicitly built to fund an actual clinical trial, the listing indicates the process will scrutinize clinical trial design, readiness to enroll participants, appropriateness of outcomes, risk management, and human subjects protections.

What outcomes or endpoints should applicants consider?

The listing emphasizes trials that can meaningfully improve treatment or day-to-day management of NF and notes that early-stage trials may refine endpoints. While specific endpoints are not detailed in the provided information, applicants should expect outcomes to be evaluated for appropriateness and relevance to NF care during review.

Is this opportunity meant to strengthen evidence for emerging approaches, or only to test entirely new interventions?

It is meant to do both. The emphasis includes testing something new as well as strengthening the evidence for approaches that are already emerging in the field, as long as the work is structured as an eligible clinical trial and is positioned to make a meaningful impact for patients.

What should applicants do if their proposed work is not yet at the clinical trial stage?

The announcement indicates that investigators whose work is preclinical should pursue other NFRP funding announcements rather than this Clinical Trial Award, since this mechanism is intended for interventional human subjects trials ready for active clinical testing.