Opportunity Information: Apply for PAR 07 373
Apply for PAR 07 373
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Multi Site Clinical Trials (R01)" 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 Dec 5, 2008 and posted on May 14, 2007.
- 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.)
- Eligible applicants include: Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Native American tribal governments (Federally recognized) Independent school districts.
- 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 Investigator Initiated Multi Site Clinical Trials (R01) opportunity (Funding Opportunity Number PAR-07-373) is a National Institutes of Health funding announcement designed to support investigator-initiated, multi-site Phase II or Phase III randomized, controlled clinical trials. The central goal is to provide a clear application pathway for researchers who want to run rigorous intervention trials across multiple locations, where the study question aligns with the mission and priorities of the National Heart, Lung, and Blood Institute (NHLBI). Projects can evaluate clinical interventions (for example, drugs, devices, procedures, or care strategies) and behavioral interventions (such as lifestyle programs or adherence and behavior change approaches), as long as the work falls within NHLBI's broad heart, lung, blood, and sleep-related research areas and strategic interests.
A key point about the scope is what this announcement does not support. It is not meant for single-center clinical studies, and it is not intended for multi-center observational research that does not test an intervention. In other words, the expectation is a true intervention trial with randomization and control, conducted at more than one site, at Phase II or Phase III scale. Applicants are also directed to consult NHLBI's Guidelines for Investigator Initiated Clinical Trials for detailed expectations around planning and submitting multi-site clinical trial applications, which typically includes considerations like trial governance, site coordination, recruitment and retention planning, data and safety monitoring, statistical design, and operational readiness.
In terms of funding mechanism, the announcement uses the NIH Research Project Grant (R01) mechanism. That means the application is submitted and reviewed as an R01, but with a specific emphasis on the complexity and infrastructure needed to run a multi-site randomized trial. The announcement also notes that NHLBI may convert awards to cooperative agreements (U01). That matters because a U01 generally involves substantial NIH programmatic involvement in the conduct of the study, so applicants should be prepared for the possibility of closer coordination with NHLBI during trial implementation if an award is converted.
The opportunity is categorized as discretionary grant funding within the health activity area, and it maps to several CFDA numbers reflecting NHLBI's program breadth, including sleep disorders research (93.233) and cardiovascular (93.837), lung (93.838), and blood diseases and resources (93.839) research. The announcement indicates there is no cost sharing or matching requirement, which simplifies budgeting in the sense that applicants are not required to provide a formal matching contribution to receive an award.
Eligibility is broad and includes many organization types across academia, government, nonprofit, and private sectors. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), and multiple levels of government such as state, county, city/township governments, special district governments, and independent school districts. Tribal governments (federally recognized) and other Native American tribal organizations are included, as are public housing authorities and Indian housing authorities. The eligibility section also explicitly states that foreign institutions are eligible to apply, eligible federal agencies may apply, and faith-based or community-based organizations may apply as well, which is helpful for global multi-site trials and community-embedded interventions.
Administratively, the funding announcement was posted May 14, 2007, with multiple receipt dates rather than a single deadline, meaning applications could be submitted across various cycles as specified in the full announcement. The archive date listed is June 7, 2010, which signals that while the summary describes the program intent and structure, applicants would need to verify current NHLBI and NIH clinical trial funding pathways for present-day submissions. The official full announcement link is provided through the NIH Grants Guide (http://grants.nih.gov/grants/guide/pa-files/PAR-07-373.html), and the contact listed for access or linking issues is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).
FAQs: Investigator Initiated Multi Site Clinical Trials (R01) (PAR-07-373)
What is PAR-07-373?
PAR-07-373 is a National Institutes of Health (NIH) funding announcement for the Investigator Initiated Multi Site Clinical Trials (R01) opportunity. It is designed to support investigator-initiated, multi-site Phase II or Phase III randomized, controlled clinical trials that align with the mission and priorities of the National Heart, Lung, and Blood Institute (NHLBI).
What types of studies does this opportunity support?
This announcement supports rigorous intervention trials conducted across more than one site, specifically Phase II or Phase III randomized, controlled clinical trials. The trials must test an intervention and include randomization and a control component.
What types of interventions can be evaluated under this announcement?
Projects may evaluate clinical interventions (such as drugs, devices, procedures, or care strategies) and behavioral interventions (such as lifestyle programs, adherence interventions, or behavior change approaches), as long as they fall within NHLBI's heart, lung, blood, and sleep-related research areas and strategic interests.
Does the study topic need to align with a specific NIH Institute?
Yes. The study question is expected to align with the mission and priorities of the National Heart, Lung, and Blood Institute (NHLBI), within its broad heart, lung, blood, and sleep-related research areas and strategic interests.
Are single-center clinical studies eligible?
No. This announcement is not intended for single-center clinical studies. The expectation is that the trial will be conducted at more than one site.
Are multi-center observational studies eligible?
No. The announcement is not intended for multi-center observational research that does not test an intervention. The expectation is a true intervention trial with randomization and control.
What trial phases are supported?
The announcement is designed to support Phase II or Phase III randomized, controlled clinical trials.
What level of trial rigor is expected?
The announcement emphasizes rigorous intervention trials, including randomization and a control. Applicants are also directed to consult NHLBI's Guidelines for Investigator Initiated Clinical Trials for detailed expectations around planning and submission.
What funding mechanism is used for this opportunity?
The opportunity uses the NIH Research Project Grant (R01) mechanism. Applications are submitted and reviewed as an R01, with emphasis on the complexity and infrastructure needed to run a multi-site randomized trial.
Can an R01 award be converted to a different award type?
Yes. The announcement notes that NHLBI may convert awards to cooperative agreements (U01). This matters because a U01 generally involves substantial NIH programmatic involvement in the conduct of the study.
What does it mean if an award is converted to a U01 cooperative agreement?
If converted to a U01, the project would typically involve closer coordination with NHLBI during trial implementation due to substantial NIH programmatic involvement, compared with a standard R01.
Is cost sharing or matching required?
No. The announcement indicates there is no cost sharing or matching requirement.
What is the activity area or general category of this funding?
The opportunity is categorized as discretionary grant funding within the health activity area.
Which CFDA numbers are associated with this opportunity?
The announcement maps to several CFDA numbers that reflect NHLBI's program breadth, including sleep disorders research (93.233) and cardiovascular (93.837), lung (93.838), and blood diseases and resources (93.839) research.
Who is eligible to apply?
Eligibility is broad and includes many organization types across academia, government, nonprofit, and private sectors. Eligible applicants include public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and other for-profits); and multiple levels of government (state, county, city/township, special district governments, and independent school districts).
Are tribal entities eligible to apply?
Yes. Tribal governments (federally recognized) and other Native American tribal organizations are included as eligible applicants.
Are public housing authorities eligible to apply?
Yes. Public housing authorities and Indian housing authorities are explicitly included in the eligibility list.
Are foreign institutions eligible to apply?
Yes. The eligibility section explicitly states that foreign institutions are eligible to apply.
Can federal agencies apply?
Yes. The eligibility section states that eligible federal agencies may apply.
Are faith-based or community-based organizations eligible?
Yes. The announcement explicitly states that faith-based or community-based organizations may apply.
Does this opportunity support global or community-embedded multi-site trials?
The eligibility language indicates that foreign institutions may apply and that faith-based or community-based organizations may apply, which can support global multi-site trials and community-embedded interventions, provided the project meets the multi-site randomized controlled Phase II/III intervention trial scope and aligns with NHLBI priorities.
When was this funding announcement posted?
The funding announcement was posted on May 14, 2007.
Is there a single application deadline?
No. The announcement notes multiple receipt dates rather than a single deadline, meaning applications could be submitted across various cycles as specified in the full announcement.
What is the archive date, and why does it matter?
The archive date listed is June 7, 2010. This signals that while the summary describes the program intent and structure, applicants would need to verify current NHLBI and NIH clinical trial funding pathways for present-day submissions.
Where can the full official announcement be found?
The full announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-07-373.html
What guidance is referenced for planning and submitting multi-site trial applications?
Applicants are directed to consult NHLBI's Guidelines for Investigator Initiated Clinical Trials for detailed expectations around planning and submitting multi-site clinical trial applications.
What kinds of operational considerations are typically included in NHLBI's multi-site clinical trial expectations?
The summary highlights typical considerations such as trial governance, site coordination, recruitment and retention planning, data and safety monitoring, statistical design, and operational readiness.
Who should be contacted for access or linking issues related to the announcement webpage?
The contact listed for access or linking issues is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 07 373) also looked into and applied for these:
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| Transfusion Related Acute Lung Injury (TRALI) Basic Research (R01) Apply for PA 07 385 Funding Number: PA 07 385 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Young Children with Mild to Severe Hearing Loss (R01) Apply for PA 07 399 Funding Number: PA 07 399 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Young Children with Mild to Severe Hearing Loss (R21) Apply for PA 07 400 Funding Number: PA 07 400 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Screening and Brief Alcohol Interventions in Underage and Young Adult Populations (R01) Apply for PA 07 406 Funding Number: PA 07 406 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Screening and Brief Alcohol Interventions in Underage and Young Adult Populations (R21) Apply for PA 07 407 Funding Number: PA 07 407 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Screening and Brief Alcohol Interventions in Underage and Young Adult Populations (R03) Apply for PA 07 408 Funding Number: PA 07 408 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Bridges to the Doctorate Program (R25) Apply for PAR 07 410 Funding Number: PAR 07 410 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Bridges to the Baccalaureate Program (R25) Apply for PAR 07 411 Funding Number: PAR 07 411 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Small Grant Program for New Investigators (R03) Apply for PAR 07 418 Funding Number: PAR 07 418 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research on Alcohol Related Public Policies such as Those Detailed in the Alcohol Policy Information System (R01) Apply for PA 07 427 Funding Number: PA 07 427 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research on Alcohol Related Public Policies such as Those Detailed in the Alcohol Policy Information System (R21) Apply for PA 07 428 Funding Number: PA 07 428 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Research on Alcohol Related Public Policies such as Those Detailed in the Alcohol Policy Information System (R03) Apply for PA 07 429 Funding Number: PA 07 429 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIGMS Postbaccalaureate Research Education Program (PREP) R25 Apply for PAR 07 432 Funding Number: PAR 07 432 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research on Interventions for Child Abuse and Neglect (R01) Apply for PA 07 437 Funding Number: PA 07 437 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Epidemiology and Prevention in Alcohol Research (R01) Apply for PA 07 448 Funding Number: PA 07 448 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Epidemiology and Prevention in Alcohol Research (R21) Apply for PA 07 449 Funding Number: PA 07 449 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
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