Opportunity Information: Apply for PAR 06 460
Apply for PAR 06 460
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Clinical Trial Planning Grant (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jan 8, 2009 and posted on Jun 14, 2006.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- Eligible applicants include: City or township governments For profit organizations other than small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education Public and State controlled institutions of higher education.
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
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Opportunity Summary:
The NINDS Clinical Trial Planning Grant (R34) is a National Institutes of Health funding opportunity designed to help research teams get a complex, high-risk, large-scale clinical trial fully organized and ready to launch. Rather than paying for the trial itself, this grant supports the behind-the-scenes planning work that often determines whether a major neurological clinical trial can actually be carried out smoothly, safely, and in a way that produces credible results. NINDS uses this mechanism to encourage well-designed trials that evaluate treatments for neurological disorders, while also providing an early checkpoint where experts can rigorously review the trial rationale and design before a much larger investment is made.
A key goal of the R34 planning grant is to enable early peer review of the proposed trial so that scientific logic, feasibility, and methodology can be refined before the study begins. In practical terms, the grant helps investigators convert a promising clinical trial concept into an implementation-ready plan by supporting the creation of a detailed Manual of Operations and Procedures (often called an MOP). That manual is expected to spell out, with operational specificity, how the study will run day to day across sites, including standardized procedures for recruitment, enrollment, intervention delivery, outcome assessments, data capture, quality control, protocol adherence, safety reporting, and staff training. For multi-site or logistically complicated trials, having this level of documentation is often what separates an executable trial from one that struggles with inconsistent implementation and unreliable data.
The opportunity also funds development of the core trial infrastructure elements that must be in place before a large clinical trial can start. This includes building or finalizing tools and systems for data management, oversight, and monitoring; detailing recruitment and retention strategies; finalizing the protocol and statistical analysis approaches; preparing administrative and coordination procedures; ensuring facilities and operational capabilities are adequate; obtaining needed regulatory clearances such as an IND (Investigational New Drug) or IDE (Investigational Device Exemption) when applicable; and putting formal collaborative arrangements in place among partners, sites, coordinating centers, or vendors. The emphasis is on readiness: the planning period is meant to eliminate avoidable uncertainty and to resolve operational, regulatory, and coordination issues ahead of time.
Just as important is what this grant is not meant to do. NINDS makes clear that the R34 is not intended to generate preliminary data and is not a vehicle for pilot studies aimed at proving the rationale for the trial. In other words, the planning grant is focused on execution planning, not hypothesis validation through additional early experimentation. By drawing that boundary, NINDS is signaling that applicants should already have sufficient scientific justification to propose the trial, and should use the R34 period to refine and lock down the design and operations rather than trying to gather supporting evidence.
The expected end product of an R34 award is a trial-ready package: a detailed clinical trial research plan along with a complete Manual of Operations and Procedures. The application must also include a completed study protocol and an estimate of projected direct costs for the future phase III trial, which helps reviewers and NINDS assess the scale and realism of the eventual full trial. This requirement reinforces the program focus on preparing for a larger definitive study, not simply performing generic planning activities.
From an administrative standpoint, this is a discretionary grant program within NIH under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The listed award ceiling is $100,000, and there is no cost sharing or matching requirement. The announcement indicates multiple receipt dates (rather than a single deadline), so applicants are expected to consult the full FOA for the specific submission schedule and any updates.
Eligibility is broad and includes many types of U.S. entities such as state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and private institutions of higher education; independent school districts; nonprofit organizations (including both 501(c)(3) and non-501(c)(3) types, excluding institutions of higher education where specified); and for-profit organizations other than small businesses. The eligibility notes also state that foreign institutions may apply, eligible federal agencies may apply, and faith-based or community-based organizations may apply, which is relatively inclusive compared with some other federal opportunities. The sponsoring agency is the National Institutes of Health, and the full announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-06-460.html.
FAQs: NINDS Clinical Trial Planning Grant (R34)
What is the NINDS Clinical Trial Planning Grant (R34)?
The NINDS Clinical Trial Planning Grant (R34) is an NIH funding opportunity that supports the planning and organizational work needed to get a complex, high-risk, large-scale neurological clinical trial fully prepared to launch. It focuses on making the proposed trial operationally and methodologically ready for implementation.
Does the R34 pay for running the clinical trial itself?
No. This award is intended to fund the behind-the-scenes planning activities that prepare a large clinical trial to start. It is not meant to cover the full costs of conducting the actual phase III trial.
Why does NINDS use an R34 planning grant mechanism?
NINDS uses the R34 to encourage well-designed neurological clinical trials and to create an early checkpoint where the trial rationale, feasibility, and methodology can be rigorously reviewed and refined before a much larger investment is made.
What types of clinical trials is this planning grant meant to support?
It is aimed at planning for complex, high-risk, large-scale clinical trials that evaluate treatments for neurological disorders, especially trials where multi-site coordination or logistical complexity makes detailed advance planning essential.
What is the main goal of the R34 period?
The main goal is trial readiness. The planning period is intended to reduce avoidable uncertainty by resolving operational, regulatory, and coordination issues in advance, and to produce an implementation-ready plan.
What is meant by "early peer review" in this context?
The R34 is designed to enable peer review of the proposed trial concept and design before the trial begins, so that scientific logic, feasibility, and methodology can be strengthened prior to moving toward a larger definitive trial.
What is a Manual of Operations and Procedures (MOP), and why is it important?
The MOP (Manual of Operations and Procedures) is a detailed document describing how the study will be run day to day, especially across multiple sites. NINDS expects the MOP to specify standardized processes so that implementation is consistent and data are credible and reliable.
What kinds of details should the MOP cover?
Based on the opportunity description, the MOP is expected to describe operational specifics for recruitment and enrollment, intervention delivery, outcome assessments, data capture, quality control, protocol adherence, safety reporting, and staff training across participating sites.
What infrastructure or trial systems can the R34 help develop or finalize?
The R34 can support development or finalization of core infrastructure elements needed before a large trial begins, including tools and systems for data management, oversight, and monitoring, as well as administrative and coordination procedures.
Can the R34 be used to finalize the clinical trial protocol and statistical approach?
Yes. The opportunity emphasizes finalizing the protocol and statistical analysis approaches as part of making the trial implementation-ready.
Does the R34 support recruitment and retention planning?
Yes. It specifically calls out detailing recruitment and retention strategies as part of the planning work to ensure the eventual trial can be executed successfully.
Can the R34 help with multi-site coordination and formal partner agreements?
Yes. The planning work can include putting formal collaborative arrangements in place among partners, sites, coordinating centers, and/or vendors, which is especially relevant for multi-site or logistically complicated trials.
Does the R34 support regulatory preparation such as IND or IDE submissions?
Yes, when applicable. The description notes that the planning grant can support obtaining needed regulatory clearances such as an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).
Is this grant intended to generate preliminary data or fund pilot studies?
No. NINDS explicitly states that the R34 is not intended to generate preliminary data and is not a vehicle for pilot studies meant to prove or validate the rationale for the trial. Applicants are expected to already have sufficient scientific justification to propose the trial.
What are the expected end products of an R34 award?
The expected end product is a trial-ready package, including a detailed clinical trial research plan and a complete Manual of Operations and Procedures (MOP).
What must the application include related to the future full-scale trial?
The application must include a completed study protocol and an estimate of projected direct costs for the future phase III trial. This helps reviewers and NINDS evaluate the scale and realism of the eventual full trial.
How much funding is available under this opportunity?
The listed award ceiling is $100,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS).
What is the CFDA number associated with this program?
The program is listed under CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders.
Are there multiple deadlines or a single submission deadline?
The announcement indicates multiple receipt dates rather than a single deadline. Applicants are expected to consult the full Funding Opportunity Announcement (FOA) for the specific submission schedule and any updates.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. entities such as state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and private institutions of higher education; independent school districts; nonprofit organizations (including 501(c)(3) and non-501(c)(3) types, excluding institutions of higher education where specified); and for-profit organizations other than small businesses.
Can foreign institutions apply?
Yes. The eligibility notes state that foreign institutions may apply.
Can federal agencies apply?
Yes. The eligibility notes state that eligible federal agencies may apply.
Are faith-based or community-based organizations eligible?
Yes. The eligibility notes state that faith-based or community-based organizations may apply.
Where can applicants find the full announcement?
The full announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-06-460.html.
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