NeuroNEXT Clinical Trials (U01 Clinical Trial Optional) | PAR 21 223

Frequently Asked Questions (FAQs): NeuroNEXT Clinical Trials (U01 Clinical Trial Optional) - PAR 21-223

What is the NeuroNEXT Clinical Trials funding opportunity (PAR 21-223)?

PAR 21-223 is a National Institutes of Health (NIH) funding opportunity led by the National Institute of Neurological Disorders and Stroke (NINDS). It supports exploratory clinical trials in neurology and is designed to generate early human evidence that helps determine what should move forward to larger, more definitive studies.

What types of studies are a good fit for this program?

This opportunity is intended for clinical trials that are not necessarily large, definitive phase 3-style trials. It is aimed at studies that produce the kind of early clinical evidence needed to justify and inform a later, larger trial, validate biomarkers, or demonstrate proof of mechanism (showing an intervention engages its intended biological target/pathway in people).

What kinds of interventions can be studied under this FOA?

The FOA supports trials of investigational agents such as drugs and biologics, as well as surgical therapies and medical devices, as long as the proposed study fits the exploratory goals described in the opportunity.

What does "proof of mechanism" mean in the context of this opportunity?

In this program, proof of mechanism refers to evidence in humans that an intervention engages its intended biological target or pathway. The purpose is to reduce uncertainty and help decide whether a larger, later-stage clinical trial is warranted and how it should be designed.

Does this program support biomarker validation?

Yes. One of the stated aims is to carry out biomarker validation, alongside generating early clinical evidence and demonstrating proof of mechanism.

What is a key benefit of being selected under this opportunity?

A key feature is access to the NeuroNEXT network infrastructure, which is built to make multicenter neurological trials faster and more consistent by relying on established coordinating centers and experienced clinical sites.

What is NeuroNEXT?

NeuroNEXT is a coordinated clinical trials network intended to improve the speed and consistency of multicenter neurological trials through established infrastructure, including coordinating centers and experienced clinical sites.

Is access to the NeuroNEXT infrastructure automatic if the application scores well in peer review?

Not necessarily. After peer review, NINDS not only funds proposals but also prioritizes and sequences which studies will receive access to the NeuroNEXT infrastructure. That means even strong applications may be scheduled based on program priorities, network capacity, and overall strategic fit.

What does it mean that NINDS will "prioritize and sequence" studies for network access?

It means selection for funding is not the only step. NINDS may determine the order and timing of which funded studies can use the NeuroNEXT infrastructure, considering program priorities, the network's capacity, and alignment with broader strategic goals.

What funding mechanism does this opportunity use?

This FOA uses a cooperative agreement mechanism (U01). Compared to a standard research grant, a U01 typically involves substantial NIH involvement in the conduct of the project.

What does "substantial NIH involvement" usually imply for a U01 cooperative agreement?

Based on the description provided, it implies that the NIH, through NeuroNEXT components, partners with the awardee to support efficient study launch and execution across multiple sites, including operational coordination and support functions such as statistics and data management.

What is the role of the NeuroNEXT Clinical Coordinating Center (CCC)?

The NeuroNEXT CCC partners with the awardee to efficiently launch and run the study. It helps with operational execution across sites and supports consistent implementation of the protocol.

What is the role of the NeuroNEXT Data Coordinating Center (DCC)?

The NeuroNEXT DCC provides statistical expertise and data management support, which is central to producing credible results and maintaining quality across multiple sites.

What do NeuroNEXT clinical sites contribute?

NeuroNEXT clinical sites provide practical trial capabilities, including support for participant recruitment and retention and reliable local implementation of the clinical protocol.

Do proposed trials need to align with NINDS priorities?

Yes. Trials are expected to align with NINDS priorities. Applicants are encouraged to choose diseases and study questions that reflect the NINDS strategic plan and clinical research interests (referenced through the NINDS funding areas webpage).

Is scientific merit the only factor considered?

No. The information provided emphasizes that alignment with NINDS programmatic interests is also important, and that network access may depend on program priorities, capacity, and strategic fit in addition to peer review outcomes.

Who is eligible to apply?

Eligibility is broad and includes many U.S. and non-U.S. organizations. Eligible applicants include various levels of government (federal, state, county, city/township, special district), public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, small businesses, other for-profit organizations, public housing authorities, and nonprofit organizations with or without 501(c)(3) status.

Are tribal entities eligible to apply?

Yes. The FOA includes federally recognized tribal governments and other Native American tribal organizations.

Are specific mission- and community-based institutions highlighted as eligible?

Yes. The FOA explicitly highlights institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations.

Are U.S. territories and foreign (non-U.S.) entities eligible?

Yes. The eligibility list includes U.S. territories or possessions, and it also includes non-U.S. (foreign) entities.

What is the funding type and activity category for this opportunity?

The opportunity is categorized as discretionary funding, uses a cooperative agreement mechanism, and falls under the Health funding activity category.

What CFDA number is associated with this opportunity?

The CFDA listing provided is 93.853.

When was this FOA created, and what closing date is listed?

The FOA was created on 2021-05-05, and the original closing date listed is 2024-03-05.

Does the summary specify an award ceiling or the expected number of awards?

No. The summary information provided does not specify an award ceiling or expected number of awards. Applicants are typically expected to consult the full FOA text and related NIH guidance for budget constraints, project period expectations, and network-specific requirements.

What kind of research team is this program best suited for?

This program is best suited for investigators with a compelling neurological clinical trial concept that is ready to be operationalized and who want the advantage of an established national trial network to improve speed, quality, and consistency.

How can this program help teams planning later-stage trials?

It can help teams de-risk later-stage trials by supporting studies that demonstrate proof of mechanism, validate biomarkers, or generate feasibility and early signal data needed to design a larger, more definitive clinical trial.

Is this opportunity limited to multicenter trials?

The opportunity is centered on providing access to a coordinated multicenter trial network (NeuroNEXT). The description focuses on multicenter consistency and network-based execution, indicating the program is designed around the NeuroNEXT infrastructure and its participating sites.

What is the main practical advantage of using the NeuroNEXT network infrastructure?

The described advantage is faster and more consistent multicenter trial execution through established coordinating centers, experienced clinical sites, centralized operational support, and strong data/statistical coordination.