Opportunity Information: Apply for PAR 16 037
Apply for PAR 16 037
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NHLBI Clinical Trial Pilot Studies (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839,.
- This funding opportunity was created on Nov 17, 2015 and posted on Nov 17, 2015.
- Applicants must submit their applications by Jan 07, 2019. (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 $225,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NHLBI Clinical Trial Pilot Studies (R34) funding opportunity (PAR 16-037) is a National Institutes of Health grant program designed to help investigators carry out targeted pilot work that directly informs the design of a future, larger clinical trial within the mission of the National Heart, Lung, and Blood Institute. The central purpose is not to fund a full-scale clinical trial, but to support the specific studies that are essential and also sufficient for making clear, evidence-based decisions about whether a larger trial should move forward and, if so, how it should be structured. In practical terms, the R34 is meant to reduce uncertainty in trial planning by generating real data on feasibility and key design assumptions before major resources are committed to a definitive trial.
This FOA is focused on clinical trials relevant to the prevention and treatment of heart, lung, blood, and sleep disorders. It supports pilot studies that answer the kinds of questions that can make or break a later trial, such as whether the proposed intervention is deliverable as intended, what intervention dose or parameters are realistic, whether eligible participants can be identified and enrolled at the necessary pace, and whether outcome measures and study procedures are workable in real-world settings. A notable emphasis is placed on testing novel and efficient trial approaches, including pragmatic designs, which are often intended to evaluate interventions under typical care conditions and can require careful upfront testing to ensure implementation and data capture are feasible.
A strong application under this announcement is expected to make a clear case that the pilot work is both necessary and sufficient to guide definitive next-step decisions about the subsequent clinical trial. "Necessary" means the larger trial cannot be responsibly designed without the pilot data because critical uncertainties remain. "Sufficient" means the proposed pilot is not an open-ended exploratory project; it should be scoped so that, at the end of the R34 period, investigators can make concrete design choices (for example, finalize eligibility criteria, recruitment strategy, randomization approach, adherence supports, site selection assumptions, or primary outcome selection and measurement plan). The NHLBI signal in the FOA is that the pilot phase should lead to robust, well-justified investigator-initiated clinical trial applications later, rather than stopping at preliminary observations.
At the same time, the announcement draws a firm boundary around what is not appropriate. Projects that are primarily administrative or preparatory without generating the feasibility evidence needed for design decisions are not responsive. Specifically, applications that propose only to write a protocol or manual of operations, or that focus mainly on building general trial infrastructure, are not considered a good fit for this mechanism. The expectation is that the award supports real-world testing and decision-enabling data collection, not planning documents alone.
From an administrative standpoint, this is a discretionary grant program in the NIH health category, associated with CFDA numbers 93.233, 93.837, 93.838, and 93.839, and administered under HHS-NIH. The eligible applicant pool is broad and includes state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); and other entities as described in the FOA eligibility details. The listed award ceiling is $225,000. The opportunity was originally posted on November 17, 2015, with a closing date of January 7, 2019 (as reflected in the provided source data).
Overall, the R34 pilot study mechanism is best understood as a focused bridge between an idea for a clinically meaningful intervention trial and a fully powered, definitive clinical trial application. It is meant to produce the feasibility and design-confirming evidence needed to justify and de-risk the next phase, with NHLBI expecting that successful R34 projects will naturally mature into strong subsequent clinical trial proposals addressing heart, lung, blood, or sleep-related conditions.
FAQs: NHLBI Clinical Trial Pilot Studies (R34) - PAR 16-037
What is the NHLBI Clinical Trial Pilot Studies (R34) opportunity (PAR 16-037)?
It is an NIH/NHLBI grant program designed to fund targeted pilot work that directly informs the design of a future, larger clinical trial that fits within the mission of the National Heart, Lung, and Blood Institute (NHLBI). The focus is on generating real feasibility and design data so investigators can make evidence-based decisions about whether a definitive trial should proceed and how it should be structured.
What is the main purpose of this R34 mechanism?
The central purpose is to reduce uncertainty in clinical trial planning by testing key feasibility and design assumptions before major resources are committed to a full-scale trial. This is a bridge mechanism: it supports the pilot studies that are essential for deciding whether a later, larger clinical trial is justified and what its core design elements should be.
Is this grant intended to fund a full-scale clinical trial?
No. The opportunity is explicitly not intended to fund a fully powered, definitive clinical trial. It supports pilot work that is targeted and decision-enabling rather than a complete confirmatory trial.
What topic areas are relevant for this FOA?
The FOA is focused on clinical trials relevant to the prevention and treatment of heart, lung, blood, and sleep disorders, consistent with the NHLBI mission.
What kinds of pilot questions are a good fit for the R34?
The R34 supports pilot studies that answer practical questions that can make or break a later trial, such as:
- Whether the intervention can be delivered as intended in real-world settings
- What intervention dose or parameters are realistic
- Whether eligible participants can be identified and enrolled at the needed pace
- Whether outcome measures and study procedures are workable and reliable
- Whether trial operations (for example, adherence supports or randomization approach) are feasible
Does this FOA emphasize any specific trial approach?
Yes. It places notable emphasis on testing novel and efficient clinical trial approaches, including pragmatic designs. Pragmatic designs often evaluate interventions under typical care conditions, which can require upfront testing to ensure implementation and data capture are feasible.
What does it mean for the pilot work to be "necessary" under this FOA?
"Necessary" means the larger clinical trial cannot be responsibly designed without pilot data because key uncertainties remain. In other words, the R34 should address specific gaps that prevent a sound definitive trial design.
What does it mean for the pilot work to be "sufficient" under this FOA?
"Sufficient" means the pilot study is intentionally scoped so that, by the end of the R34, investigators can make concrete, defensible design choices for the next trial. The pilot is not meant to be open-ended exploration; it should lead to clear go/no-go and design decisions.
What kinds of decisions should an R34 pilot study enable by the end of the project?
Based on the FOA description, the pilot should support finalizing key design elements for a future trial, such as:
- Eligibility criteria
- Recruitment strategy and enrollment assumptions
- Randomization approach
- Adherence supports
- Site selection assumptions
- Primary outcome selection and the measurement plan
What is NHLBI expecting to happen after a successful R34?
NHLBI is signaling that successful R34 pilot projects should mature into robust, well-justified investigator-initiated clinical trial applications. The pilot phase is intended to de-risk and strengthen the next step rather than end with preliminary observations alone.
What types of projects are not considered appropriate for this R34?
Projects that are primarily administrative or preparatory without generating feasibility evidence needed for design decisions are described as not responsive. Examples include applications proposing only to write a protocol or manual of operations, or projects focused mainly on building general trial infrastructure.
Can an application focus only on planning documents (like a protocol) without running pilot testing?
No. The FOA indicates that planning documents alone are not a good fit. The expectation is real-world testing and data collection that directly informs trial design decisions, not protocol development by itself.
What kind of data is this R34 meant to produce?
It is meant to generate feasibility and design-confirming data that reduce uncertainty in the future clinical trial plan. The emphasis is on evidence that supports clear decisions about whether to proceed and how to structure the larger trial.
Who administers this funding opportunity?
It is administered under HHS-NIH as an NIH discretionary grant program in the NIH health category, associated with NHLBI.
What are the CFDA numbers associated with this opportunity?
The opportunity is associated with CFDA numbers 93.233, 93.837, 93.838, and 93.839.
Who is eligible to apply?
The eligible applicant pool is broad and includes (as described in the provided information): state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); and other entities described in the FOA eligibility details.
What is the maximum award amount listed for this opportunity?
The listed award ceiling is $225,000.
When was this opportunity posted, and what closing date is listed?
The opportunity was originally posted on November 17, 2015, and the closing date listed in the provided source data is January 7, 2019.
What is the simplest way to describe the R34 in the clinical trial pipeline?
It functions as a focused bridge between a clinically meaningful intervention trial concept and a fully powered definitive clinical trial application, producing feasibility and design evidence to justify and de-risk the next phase.
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