Opportunity Information: Apply for PAR 10 005
Apply for PAR 10 005
- The National Institutes of Health 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 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Oct 2, 2009 and posted on Oct 2, 2009.
- Applicants must submit their applications by Jan 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $450,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments City or township governments Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) State governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) Small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NHLBI Clinical Trial Pilot Studies (R34) opportunity (Funding Opportunity Number PAR-10-005) is an NIH grant program designed to support small, focused pilot studies that generate the kinds of practical evidence investigators need before launching a full-scale clinical trial. The central idea is to fund the missing pieces of information that commonly prevent an otherwise strong clinical trial concept from being competitive or scientifically solid. NHLBI is looking for projects that directly reduce uncertainty in trial planning by producing data that will make a later, larger investigator-initiated clinical trial more feasible, more rigorous, and more likely to succeed in evaluating interventions related to heart, lung, blood, or sleep disorders.
The FOA emphasizes that the pilot work must be truly trial-enabling. Appropriate projects include studies that test whether an intervention can be delivered as intended in the target setting, whether participants can be recruited, enrolled, and retained at acceptable rates, and whether the proposed experimental design is workable. It can also include efforts to estimate key parameters needed for a definitive trial, such as effect size signals, variability estimates, adherence rates, event rates, safety signals, or the performance of outcome measures and data collection procedures. In other words, the R34 is meant to answer specific design-critical questions so that the next-step clinical trial can be planned with stronger assumptions and less risk.
Just as important are the activities that this FOA does not support. Applications that mainly propose writing a protocol, developing a manual of operations, or building trial infrastructure without actually conducting pilot studies and producing data are described as nonresponsive to the announcement. NHLBI is clearly drawing a line between preparatory administrative work and empirical pilot research; to be considered appropriate, the application must show that the proposed pilot studies are both necessary (they address real gaps that currently block a full trial) and sufficient (they will provide enough information to permit a well-justified full-scale trial design).
Peer review under this program is not limited to the pilot study in isolation. Reviewers will also consider the significance and potential public health impact of the larger clinical trial that the investigators intend to propose after the R34 period. That means applicants need to present a convincing vision for the eventual full-scale trial, including why the clinical question matters, how the intervention could improve prevention or treatment, and why the resulting definitive trial would be meaningful to public health in the NHLBI mission areas.
The mechanism of support is the NIH R34 (Clinical Trial Planning Grant-like pilot mechanism in this context), and awards are contingent on the availability of funds and the receipt of a sufficient number of meritorious applications. The total estimated funding listed for this opportunity is $450,000, with an award ceiling of $225,000. No cost sharing or matching is required. The program was posted on October 2, 2009, and the original and current closing date shown is January 7, 2013, with an archive date of February 7, 2013, indicating it is an archived funding announcement rather than an active one.
Eligibility is broad and spans many organization types. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses) as well as small businesses, state and local governments (including county, city/township, special district, and independent school districts), public housing authorities/Indian housing authorities, Native American tribal governments (both federally recognized and other than federally recognized) and tribal organizations, and a range of mission- or community-focused institutions. The eligibility list explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
From a topical standpoint, the FOA aligns with multiple NHLBI-related CFDA program areas, including the National Center on Sleep Disorders Research (93.233), Cardiovascular Diseases Research (93.837), Lung Diseases Research (93.838), and Blood Diseases and Resources Research (93.839). The sponsoring agency is the National Institutes of Health, with NHLBI as the institute inviting applications. The full announcement was hosted on the NIH Grants Guide site (PAR-10-005), and applicants were directed to NIH Office of Extramural Research contacts for technical issues accessing the announcement.
In practical terms, this grant is best understood as a bridge between an idea for a major clinical trial and the evidence needed to responsibly launch that trial. It is meant to turn a promising concept into a trial-ready plan by funding tightly scoped, data-generating pilot work that strengthens design choices, improves feasibility, and increases the likelihood that the subsequent full clinical trial application will be competitive and that the eventual trial will be robust and informative.
Frequently Asked Questions (FAQs): NHLBI Clinical Trial Pilot Studies (R34) - PAR-10-005
What is the NHLBI Clinical Trial Pilot Studies (R34) opportunity?
This funding opportunity (PAR-10-005) is an NIH/NHLBI grant program that supports small, focused pilot studies intended to generate practical, data-driven evidence needed before launching a full-scale, investigator-initiated clinical trial. The goal is to fund targeted pilot work that reduces uncertainty and strengthens the scientific and operational foundation for a later definitive trial in NHLBI mission areas (heart, lung, blood, or sleep disorders).
What is the main purpose of this R34 program?
The program is designed to support trial-enabling pilot research that fills specific gaps that commonly prevent an otherwise promising clinical trial concept from being feasible, rigorous, or competitive. It is meant to provide the missing empirical information needed to justify design choices and reduce risk in planning a later, larger clinical trial.
What kinds of projects are considered appropriate under this FOA?
Appropriate projects are pilot studies that directly inform the feasibility and design of a future full-scale clinical trial. Examples described in the FOA include pilots that test whether an intervention can be delivered as intended in the target setting, and whether participants can be recruited, enrolled, and retained at acceptable rates. The FOA also supports studies that evaluate whether the proposed experimental design is workable.
What types of data or parameters can the pilot studies generate?
The FOA emphasizes pilot work that estimates or validates key inputs needed for a definitive trial, such as effect size signals, variability estimates, adherence rates, event rates, safety signals, and the performance of outcome measures and data collection procedures. The overarching idea is to produce design-critical data so that the subsequent full trial can be planned with stronger assumptions and less uncertainty.
What does "trial-enabling" mean in this context?
In this FOA, "trial-enabling" means the pilot work must be directly tied to making a later clinical trial feasible and rigorous. The pilot studies should answer specific questions that currently block the full trial (for example, uncertainty about recruitment, retention, delivery of the intervention, or the practicality of the design and measurements).
What does this FOA explicitly not support?
The announcement states that applications focused mainly on writing a protocol, developing a manual of operations, or building trial infrastructure without actually conducting pilot studies and generating data are considered nonresponsive. NHLBI draws a clear line between preparatory administrative work and empirical pilot research for this mechanism.
Can an application focus only on planning documents and infrastructure development?
No. The FOA describes projects that primarily propose protocol writing, manual-of-operations development, or infrastructure building without data-generating pilot studies as nonresponsive to the announcement.
How will applications be reviewed under this program?
Peer review will consider not only the pilot study itself, but also the significance and potential public health impact of the larger clinical trial that the investigators intend to propose after the R34 period. Applicants are expected to articulate a convincing vision for the eventual full-scale trial, including why the clinical question matters and how a definitive trial would be meaningful to public health within NHLBI mission areas.
Do reviewers consider the future full-scale clinical trial when scoring the R34?
Yes. The FOA indicates reviewers will consider the significance and potential public health impact of the future full-scale clinical trial that is intended to follow the R34 pilot work, not just the pilot in isolation.
What is the funding mechanism for this opportunity?
The mechanism is the NIH R34, used here as a clinical trial pilot studies mechanism intended to support focused, trial-enabling pilot research that informs a later investigator-initiated clinical trial.
How much funding is available and what is the award ceiling?
The total estimated funding listed for the opportunity is $450,000, and the award ceiling is $225,000.
Is cost sharing or matching required?
No. The FOA states that no cost sharing or matching is required.
Are awards guaranteed if an application is meritorious?
No. The FOA notes that awards are contingent on the availability of funds and the receipt of a sufficient number of meritorious applications.
Is this funding opportunity currently active?
The dates provided indicate it is archived rather than active. It was posted on October 2, 2009; the original and current closing date shown is January 7, 2013; and the archive date is February 7, 2013.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-10-005.
Which agency and institute are sponsoring and inviting applications?
The sponsoring agency is the National Institutes of Health (NIH), and the institute inviting applications is the National Heart, Lung, and Blood Institute (NHLBI).
What research areas does this FOA align with?
The FOA aligns with NHLBI mission areas related to interventions for heart, lung, blood, or sleep disorders. It also aligns with multiple CFDA program areas, including National Center on Sleep Disorders Research (93.233), Cardiovascular Diseases Research (93.837), Lung Diseases Research (93.838), and Blood Diseases and Resources Research (93.839).
Who is eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and for-profit organizations other than small businesses); and multiple government and community-based entities.
Are state and local government entities eligible?
Yes. The eligibility list includes state governments and local governments, including county, city/township, special district, and independent school districts.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include Native American tribal governments (federally recognized and other than federally recognized) and Native American tribal organizations.
Are U.S. territories or possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions.
Are faith-based and community-based organizations eligible?
Yes. The eligibility list explicitly includes faith-based or community-based organizations.
Are minority-serving institutions specifically included?
Yes. The eligibility list explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included in the eligible applicant types.
What is meant by "missing pieces of information" for trial planning?
The FOA describes funding the kinds of data that commonly block a full-scale clinical trial from being competitive or scientifically solid. These are design-critical unknowns, such as recruitment and retention feasibility, deliverability of the intervention, workable experimental design, adherence expectations, event rates, safety signals, and how well outcome measures and data collection procedures perform in practice.
Where was the full announcement posted?
The full announcement was hosted on the NIH Grants Guide site under PAR-10-005.
Where were applicants directed for technical issues accessing the announcement?
Applicants were directed to NIH Office of Extramural Research contacts for technical issues related to accessing the announcement.
In simple terms, what is this grant best used for?
The FOA characterizes this grant as a bridge between an idea for a major clinical trial and the practical evidence needed to responsibly launch that trial. It funds tightly scoped, data-generating pilot work to strengthen design choices, improve feasibility, and increase the likelihood that a subsequent full clinical trial application will be competitive and the eventual trial will be robust and informative.
Browse more opportunities from the same category: Health
Next opportunity: Region 6 Migratory Bird Program
Previous opportunity: Drug Discovery for Nervous System Disorders (R01)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 10 005
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 10 005) also looked into and applied for these:
| Funding Opportunity |
|---|
| Biobehavioral Research Awards for Innovative New Scientists (BRAINS) (R01) Apply for RFA MH 10 060 Funding Number: RFA MH 10 060 Agency: National Institutes of Health Category: Health Funding Amount: $400,000 |
| Strengthening Clinical Services in Lesotho Apply for RFA 674 10 0001 Funding Number: RFA 674 10 0001 Agency: South Africa USAID Pretoria Category: Health Funding Amount: $25,000,000 |
| Comparing Design Approaches for Sequencing Disease Associated Regions found in Genome Wide Association Studies (U01) Apply for RFA HG 09 014 Funding Number: RFA HG 09 014 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
| Morris K. Udall Centers of Excellence for Parkinsons Disease Research (P50) Apply for RFA NS 10 001 Funding Number: RFA NS 10 001 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| State and Regional Primary Care Association (PCA) Cooperative Agreements Apply for HRSA 10 115 Funding Number: HRSA 10 115 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| MBRS Research Initiative for Scientific Enhancement (RISE) (R25) Apply for PAR 10 004 Funding Number: PAR 10 004 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Water, Sanitation and Hygiene (WASH) Program in Liberia Apply for 669 10 001 Funding Number: 669 10 001 Agency: Liberia USAID Monrovia Category: Health Funding Amount: $10,500,000 |
| Cellular and Molecular Mechanisms of Arterial Stiffening and Its Relationship to Development of Hypertension (R01) Apply for RFA HL 10 027 Funding Number: RFA HL 10 027 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| NHLBI Cardiovascular Outcomes Research Coordinating Unit (U01) Apply for RFA HL 10 018 Funding Number: RFA HL 10 018 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| NHLBI Centers for Cardiovascular Outcomes Research (U01) Apply for RFA HL 10 008 Funding Number: RFA HL 10 008 Agency: National Institutes of Health Category: Health Funding Amount: $920,000 |
| Medical Liability Reform and Patient Safety Planning Grants (R21) Apply for RFA HS 10 022 Funding Number: RFA HS 10 022 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $300,000 |
| Medical Liability Reform and Patient Safety Demonstration Projects (R18) Apply for RFA HS 10 021 Funding Number: RFA HS 10 021 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $3,000,000 |
| Roadmap Transformative Research Projects Program (R01) Apply for RFA RM 09 022 Funding Number: RFA RM 09 022 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Case Ascertainment to Estimate the U.S. Prevalence of Fetal Alcohol Spectrum Disorders in Young Children (U01) Apply for RFA AA 10 005 Funding Number: RFA AA 10 005 Agency: National Institutes of Health Category: Health Funding Amount: $1,400,000 |
| Metagenomic Evaluation of Oral Polymicrobial Disease (R01) Apply for RFA DE 10 003 Funding Number: RFA DE 10 003 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Grants to Expand Substance Abuse Treatment Capacity in Targeted Areas of Need Local Recovery Oriented Systems of Care Apply for TI 10 007 Funding Number: TI 10 007 Agency: Substance Abuse Mental Health Services Adminis. Category: Health Funding Amount: $400,000 |
| Population Based Birth Defects Surveillance and Utilization of Surveillance Data by Public Health Programs Apply for CDC RFA DD10 1001 Funding Number: CDC RFA DD10 1001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $220,000 |
| Preventing Unintentional Childhood Injuries (R21) Apply for RFA CE 10 001 Funding Number: RFA CE 10 001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $175,000 |
| Public Health Conference Support Program Apply for CDC RFA DD10 1003 Funding Number: CDC RFA DD10 1003 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $100,000 |
| Research Grants for Preventing Violence and Violence Related Injury (R01) Apply for RFA CE 10 005 Funding Number: RFA CE 10 005 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $400,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 10 005", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.