Opportunity Information: Apply for PAR 18 768
Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (PAR 18-768) is an NIH opportunity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) that is meant to strengthen the planning of investigator-initiated clinical trials in the heart, lung, blood, and sleep space. The central idea is not to fund the conduct of a clinical trial, but to give research teams access to specialized consultation that helps them design a late-phase study (Phase II and beyond) that is both feasible and methodologically strong. It is specifically aimed at trials where a traditional, straightforward randomized design may not be the best fit and where there is room for statistical novelty or innovation in the design and/or the statistical analysis plan.
The support offered through this announcement is framed as access to a consultative resource rather than a standard research grant that pays for enrollment, interventions, or follow-up. Awardees are connected to the Innovative Clinical Trials Resource (ICTR) (supported under an N01 mechanism), which provides expert input during the planning stage. In practical terms, this means applicants can seek help refining complex trial designs, working through challenging operational constraints for single-site or multi-site trials, and developing a rigorous statistical analysis plan that matches the scientific question and the realities of trial execution. The emphasis is on producing a well-designed and actionable trial plan that can answer an important clinical question aligned with NHLBI priorities.
A defining feature of this FOA is its focus on non-traditional designs and innovative statistical approaches. While the announcement text does not list specific design types, the intent typically covers situations where investigators may be considering adaptive features, pragmatic elements, enrichment strategies, cluster designs, novel endpoints, complex longitudinal outcomes, efficient randomization schemes, or other approaches that require careful statistical thinking and clear justification. The goal is to ensure that late-phase trials using these approaches are not only creative, but also credible, interpretable, and realistically implementable, with pre-specified methods that reduce ambiguity and improve the quality of eventual results.
This is an X01 resource access mechanism, and it is clearly labeled "Clinical Trial Not Allowed." That designation signals that the application itself should not propose to carry out a clinical trial under this award. Instead, the project period is focused on planning activities supported through consultation. The expected deliverable is essentially a stronger, more complete, and better-defended trial design package (including the statistical analysis plan) that could position a team for a later submission to conduct the trial under an appropriate clinical trial funding mechanism.
Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA explicitly highlights additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.
Foreign eligibility is limited in a way that matters for planning collaborations. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply directly. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. In other words, a U.S. applicant organization can include certain foreign elements or sites/components consistent with NIH policy, but a standalone foreign institution cannot be the applicant.
Administratively, this is a discretionary grant opportunity under NIH, categorized under health, and associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The original closing date listed in the source information is October 19, 2018, and the opportunity was created May 3, 2018. The award ceiling and expected number of awards are not specified in the provided source text, which is consistent with a resource-access style program where support is delivered primarily through structured consultation rather than large direct-cost research budgets.
Overall, the opportunity is best understood as a planning accelerator for sophisticated late-phase NHLBI-relevant trials: it helps investigators pressure-test trial concepts, resolve design and analysis complexities, and produce a high-quality, defensible statistical analysis plan and protocol framework before seeking funding to actually run the study.Apply for PAR 18 768
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (X01 Clinical Trial Not Allowed)" 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, 93.840.
- This funding opportunity was created on 2018-05-03.
- Applicants must submit their applications by 2018-10-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the purpose of "Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (PAR 18-768)"?
This NIH opportunity (sponsored by the National Heart, Lung, and Blood Institute, NHLBI) is designed to strengthen the planning of investigator-initiated late-phase clinical trials in the heart, lung, blood, and sleep space. The focus is on improving trial design and the statistical analysis plan (SAP), especially for studies where non-traditional designs or innovative statistical approaches may be needed.
Does this opportunity fund the conduct of a clinical trial?
No. The central idea is not to fund enrollment, interventions, follow-up, or trial operations. It is explicitly an X01 resource access mechanism labeled "Clinical Trial Not Allowed," meaning you should not propose to carry out a clinical trial under this award.
What kind of support does the award provide instead of trial funding?
The program provides access to specialized consultation through the Innovative Clinical Trials Resource (ICTR), which is supported under an N01 mechanism. The support is framed as consultative resource access to help teams plan a feasible, methodologically strong late-phase trial and develop a rigorous statistical analysis plan.
Who provides the consultation supported by this announcement?
Awardees are connected to the Innovative Clinical Trials Resource (ICTR), which provides expert input during the planning stage to help refine trial design and statistical analysis plans.
What trial phases are targeted by this resource access program?
It is aimed at late-phase studies, described as Phase II and beyond.
What scientific areas are in scope for this FOA?
The opportunity is intended for investigator-initiated clinical trials in the heart, lung, blood, and sleep space, aligned with NHLBI priorities.
What types of trial design challenges is this program meant to address?
It is intended for situations where a traditional, straightforward randomized design may not be the best fit and where there is room for statistical novelty or innovation in the design and/or the statistical analysis plan. It supports teams working through complex design issues and operational constraints for single-site or multi-site trials.
Does the FOA focus on innovative or non-traditional trial designs?
Yes. A defining feature of this FOA is its focus on non-traditional designs and innovative statistical approaches, with the goal of ensuring late-phase trials are credible, interpretable, and realistically implementable with clear, pre-specified methods.
Are specific non-traditional design types listed in the provided information?
No. The provided description does not list specific design types, but it indicates the intent typically covers cases where investigators are considering designs or analysis approaches that require careful statistical thinking and clear justification.
What are the expected outcomes or deliverables from the planning support?
The expected deliverable is a stronger, more complete, and better-defended trial design package, including a rigorous statistical analysis plan. The goal is to produce a well-designed and actionable trial plan that can answer an important clinical question aligned with NHLBI priorities.
How should applicants think about this mechanism when planning next steps for funding?
This resource access award is best understood as a planning accelerator. It is intended to position a team for a later submission to conduct the trial under an appropriate clinical trial funding mechanism, rather than supporting trial execution itself.
What is the mechanism type for this opportunity?
This is an X01 resource access mechanism.
What does "Clinical Trial Not Allowed" mean for an application under this FOA?
It means the application should not propose to carry out a clinical trial as part of the award. The project period is focused on planning activities supported through consultation rather than implementing the trial.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations and government entities. Examples listed include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities.
Are specific institution types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; Indian/Native American tribal governments other than federally recognized; and U.S. territories or possessions.
Can a non-U.S. (foreign) organization apply directly?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply directly as the applicant organization.
Are any foreign components allowed in a project?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. In practice, a U.S. applicant organization can include certain foreign elements or sites/components consistent with NIH policy, even though a standalone foreign institution cannot be the applicant.
Is this opportunity associated with specific NIH institute sponsorship?
Yes. It is sponsored by the National Heart, Lung, and Blood Institute (NHLBI).
How is this opportunity categorized?
It is an NIH discretionary grant opportunity categorized under health.
What CFDA numbers are associated with this opportunity?
The provided information associates this opportunity with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840.
When was the opportunity created and what closing date is listed?
The provided information states the opportunity was created May 3, 2018, and lists an original closing date of October 19, 2018.
Is the award ceiling or expected number of awards provided?
No. The award ceiling and expected number of awards are not specified in the provided information, which is consistent with a resource-access style program where support is delivered primarily through structured consultation rather than large research budgets.
What kinds of operational trial considerations can the consultation help with?
The consultation is described as supporting planning for challenging operational constraints in both single-site and multi-site trials, along with refining complex trial designs and ensuring the statistical analysis plan matches both the scientific question and the realities of execution.
What is the overall value proposition of this FOA for investigators?
It helps investigators pressure-test trial concepts, resolve design and analysis complexities, and produce a high-quality, defensible statistical analysis plan and protocol framework before seeking funding to actually run the study.
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| NIOSH Occupational Safety and Health Research (R01) Apply for PAR 18 769 Funding Number: PAR 18 769 Agency: National Institutes of Health Category: Health Funding Amount: $400,000 |
| NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22 Independent Clinical Trial Not Allowed) Apply for PAR 18 772 Funding Number: PAR 18 772 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Novel Genomic Technology Development (R21 Clinical Trial Not Allowed) Apply for PAR 18 778 Funding Number: PAR 18 778 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Novel Genomic Technology Development (R01 Clinical Trial Not Allowed) Apply for PAR 18 777 Funding Number: PAR 18 777 Agency: National Institutes of Health Category: Health Funding Amount: $700,000 |
| NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22 Clinical Trial Required) Apply for PAR 18 771 Funding Number: PAR 18 771 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Novel Genomic Technology Development (R43/R44 Clinical Trial Not Allowed) Apply for PAR 18 779 Funding Number: PAR 18 779 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Prevention Technology Transfer Centers Cooperative Agreements (Short Title: PTTC) Apply for SP 19 001 Funding Number: SP 19 001 Agency: Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $7,500,000 |
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| Collaborative Cross (CC) Mouse Model Generation and Discovery of Immunoregulatory Mechanisms (R21 Clinical Trials Not Allowed) Apply for PAR 18 781 Funding Number: PAR 18 781 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Collaborative Network to Advance Deprescribing Research for Older Adults with Multiple Chronic Conditions (R24 Clinical Trial Optional) Apply for RFA AG 19 005 Funding Number: RFA AG 19 005 Agency: National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed) Apply for RFA OD 18 005 Funding Number: RFA OD 18 005 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Required) Apply for RFA OD 18 006 Funding Number: RFA OD 18 006 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Wearable Alcohol Biosensors (SBIR) (R43/R44- Clinical Trial Optional) Apply for PA 18 786 Funding Number: PA 18 786 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Wearable Alcohol Biosensors (STTR) (R41/R42- Clinical Trial Optional) Apply for PA 18 785 Funding Number: PA 18 785 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required) Apply for RFA OD 18 008 Funding Number: RFA OD 18 008 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| The Mechanistic Role of the Microbiome in the Pathobiology of Heart, Lung, Blood, and Sleep Diseases (R01 - Clinical Trial Not Allowed) Apply for PA 18 784 Funding Number: PA 18 784 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Not Allowed) Apply for RFA OD 18 007 Funding Number: RFA OD 18 007 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Precision Imaging of Oral Lesions (R21-Clinical Trial Not Allowed) Apply for PAR 18 788 Funding Number: PAR 18 788 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| USAID/Nigeria Orphans and Vulnerable Children Social Service Activities (OSSA) Apply for RFI 620 18 OVC Funding Number: RFI 620 18 OVC Agency: Nigeria USAID-Abuja Category: Health Funding Amount: $70,000,000 |
| Advancing Evidence into Practice through Shared, Interoperable Clinical Decision Support Resources (U18) Apply for PA 18 792 Funding Number: PA 18 792 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $500,000 |
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