Opportunity Information: Apply for PAR 13 128
Apply for PAR 13 128
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Multi Site Clinical Trials (Collaborative 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 Mar 1, 2013 and posted on Mar 1, 2013.
- Applicants must submit their applications by May 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education County governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Independent school districts 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 Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed
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Opportunity Summary:
The Investigator Initiated Multi Site Clinical Trials (Collaborative R01) funding opportunity (PAR 13-128) was an NHLBI-linked NIH grant mechanism designed to support investigator-led, multi-site randomized controlled clinical trials. The central idea behind the program was to give researchers a clear pathway to propose and run rigorous trials that can answer clinically meaningful questions tied to the NHLBI mission, including heart, lung, blood, and sleep disorders. By emphasizing multi-site recruitment, the announcement aimed to improve the speed, generalizability, and real-world relevance of evidence on prevention strategies, diagnostic approaches, and treatment options.
This FOA focused specifically on phase II and phase III randomized clinical trials that recruit participants across multiple locations. It welcomed both classic efficacy trials (designed to test whether an intervention works under more controlled conditions) and large-scale pragmatic trials, including comparative effectiveness studies (designed to compare interventions in settings that resemble routine practice). Importantly, the trial designs could randomize individuals (patients) or randomize groups such as clinics, schools, or workplaces, which allows investigators to match the randomization approach to how an intervention is actually delivered. The FOA also explicitly noted that rare disease trials relevant to NHLBI priorities can be a strong fit, since rare conditions often require coordination across many sites to enroll enough participants.
A key boundary in the announcement was what it would not support. It was not intended for single-center studies, and it was not meant for multicenter observational research that does not test an intervention. In other words, the expectation was a true interventional clinical trial with randomization and multiple recruiting sites, using a study design that is efficient and well aligned with the specific aims.
The opportunity fell under the NIH discretionary grant category, using the R01 activity code in a collaborative, multi-site clinical trial context. It mapped to several CFDA program areas: 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), and 93.839 (Blood Diseases and Resources Research). There was no cost sharing or matching requirement.
Operationally, the FOA highlighted an important application structure requirement tied to budget scale. When proposed clinical trial costs exceeded $500,000 in any year (excluding facilities and administrative costs for subcontracts), applications for a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) were required to be submitted together. This reflects the reality that large multi-site trials typically need dedicated infrastructure for site management, participant recruitment and retention, protocol adherence, regulatory coordination, and separate specialized capacity for data systems, statistical oversight, quality control, and final analyses.
Eligibility was broad and included many types of domestic U.S. organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and other nonprofit structures), small businesses, for-profit entities (other than small businesses), independent school districts, and various local, county, state, tribal, and special district governments, along with public housing authorities/Indian housing authorities. The announcement also opened eligibility to a wide range of mission-serving institutions and community-based organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations. Non-U.S. entities were also eligible: foreign organizations and foreign institutions could apply, non-U.S. components of U.S. organizations were allowed, and foreign components (as defined by NIH policy) were permitted.
Timeline-wise, the FOA was posted and created on March 1, 2013, with an original and current closing date listed as May 7, 2016, and an archive date of June 7, 2016, meaning it is no longer active as an open opportunity. The sponsoring agency was the National Institutes of Health, and applicants were directed to NHLBI strategic planning materials for alignment with institute priorities. The full announcement was available through the NIH grants guide (linked in the record), and general technical access issues were routed through the NIH Office of Extramural Research webmaster contact.
Frequently Asked Questions (FAQs)
What is PAR 13-128 (Investigator Initiated Multi Site Clinical Trials - Collaborative R01)?
PAR 13-128 was an NHLBI-linked NIH funding opportunity that used the R01 grant mechanism to support investigator-initiated, multi-site randomized controlled clinical trials. It was designed to give researchers a defined route to propose and conduct rigorous trials that address clinically meaningful questions aligned with the NHLBI mission in heart, lung, blood, and sleep disorders.
Which NIH institute is associated with this opportunity?
The opportunity was linked to the National Heart, Lung, and Blood Institute (NHLBI) under the National Institutes of Health (NIH).
Is this funding opportunity still open?
No. The record lists a closing date of May 7, 2016, and an archive date of June 7, 2016, indicating the opportunity is no longer active.
What types of clinical trials were supported?
The FOA focused on phase II and phase III randomized clinical trials conducted across multiple recruiting sites.
Does the FOA support both efficacy and pragmatic trials?
Yes. It welcomed classic efficacy trials (more controlled conditions) and large-scale pragmatic trials, including comparative effectiveness studies conducted in settings that resemble routine practice.
Are comparative effectiveness studies allowed under this FOA?
Yes. Comparative effectiveness studies were explicitly included as part of the pragmatic trial designs welcomed by the FOA.
Does the trial have to be randomized?
Yes. The FOA emphasized randomized controlled clinical trials, with an expectation of a true interventional clinical trial that includes randomization.
Does the FOA allow cluster randomization (randomizing clinics, schools, workplaces, etc.)?
Yes. Trial designs could randomize individuals (patients) or groups (for example, clinics, schools, or workplaces), allowing investigators to match the randomization strategy to how the intervention is delivered.
Does the FOA support rare disease trials?
Yes, when the rare disease trial is relevant to NHLBI priorities. The FOA noted rare disease trials can be a strong fit because enrolling enough participants often requires coordination across many sites.
Is a single-center clinical trial eligible?
No. The FOA was not intended for single-center studies; it specifically emphasized multi-site recruitment.
Does the FOA support multicenter observational studies?
No. It was not intended for multicenter observational research that does not test an intervention. The expectation was an interventional, randomized clinical trial.
What is the main purpose of requiring multiple recruiting sites?
By emphasizing multi-site recruitment, the FOA aimed to improve the speed of enrollment and enhance generalizability and real-world relevance of evidence on prevention strategies, diagnostic approaches, and treatment options.
What grant mechanism and category did this FOA use?
It used the NIH R01 activity code in a collaborative, multi-site clinical trial context, and it fell under the NIH discretionary grant category.
Which CFDA program areas were associated with this opportunity?
The FOA mapped to several CFDA program areas: 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), and 93.839 (Blood Diseases and Resources Research).
Is cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement.
When are applications for a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) required to be submitted together?
When proposed clinical trial costs exceed $500,000 in any year (excluding facilities and administrative costs for subcontracts), applications for a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) were required to be submitted together.
How is the $500,000 threshold defined in the FOA?
The threshold applies to proposed clinical trial costs that exceed $500,000 in any year, and it excludes facilities and administrative (F&A) costs for subcontracts.
Why does the FOA require both a CCC and a DCC for larger-budget trials?
The FOA described this as reflecting the operational reality of large multi-site trials, which often need dedicated infrastructure for site management, recruitment and retention, protocol adherence, and regulatory coordination (CCC), as well as specialized capacity for data systems, statistical oversight, quality control, and final analyses (DCC).
What kinds of U.S. organizations were eligible to apply?
Eligibility was broad and included public and private institutions of higher education, nonprofits (including 501(c)(3) and other nonprofit structures), small businesses, for-profit entities (other than small businesses), independent school districts, and various local, county, state, tribal, and special district governments, including public housing authorities/Indian housing authorities.
Were community-based and mission-serving institutions eligible?
Yes. The FOA opened eligibility to institutions and organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations.
Could non-U.S. entities apply?
Yes. Foreign organizations and foreign institutions could apply. Non-U.S. components of U.S. organizations were allowed, and foreign components (as defined by NIH policy) were permitted.
When was the FOA created and posted?
The FOA was created and posted on March 1, 2013.
What were the listed closing and archive dates?
The original and current closing date was listed as May 7, 2016, and the archive date was June 7, 2016.
Where could applicants find the full announcement?
The full announcement was available through the NIH Grants Guide link referenced in the record.
Where were applicants directed for alignment with NHLBI priorities?
Applicants were directed to NHLBI strategic planning materials to help align proposed trials with institute priorities.
Who was listed as the contact for technical access issues?
General technical access issues were routed through the NIH Office of Extramural Research webmaster contact.
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