Opportunity Information: Apply for PAR 10 198
Apply for PAR 10 198
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS PHASE III Investigator Initiated Multi Site Clinical Trials (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Mar 22, 2011 and posted on May 14, 2010.
- Applicants must submit their applications by Mar 21, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Small businesses County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This funding opportunity, titled "NINDS PHASE III Investigator Initiated Multi Site Clinical Trials (U01)" (Funding Opportunity Number PAR-10-198), was a National Institutes of Health (NIH) program issued by the National Institute of Neurological Disorders and Stroke (NINDS) to support investigator-initiated, multi-site Phase III clinical trials. The central aim was to provide a clear application pathway for large, definitive, randomized, controlled trials that test an intervention and address important questions within NINDS's mission area, meaning diseases and disorders of the nervous system, stroke, and related neurological conditions. The FOA was specifically oriented toward late-stage, confirmatory trials rather than exploratory or early feasibility work, and it emphasized rigorous trial design appropriate for Phase III research, where the goal is typically to establish efficacy and safety in a way that can change clinical practice.
A key boundary of the program is what it would not support. It was not intended for single-center clinical studies, and it was not intended for multi-center observational studies that do not actually test an intervention. In other words, simply following cohorts, collecting natural history data, or running non-interventional registries would not fit this announcement. The focus is on trials where participants are assigned (typically randomly) to one or more intervention arms and a control arm and where outcomes are measured under a protocol designed to produce high-quality evidence.
The award mechanism is a U01 cooperative agreement, which matters because it signals a more collaborative relationship with NIH than a typical investigator-initiated R01 grant. Under a cooperative agreement, NINDS generally expects substantial programmatic involvement, which can include participation in trial oversight, milestone monitoring, and coordination on issues like protocol adherence, recruitment performance, safety monitoring, and data quality. This structure is commonly used for large, complex clinical trials where active NIH engagement helps ensure consistency and reliability across multiple sites.
A distinctive requirement in this FOA is that NINDS required separate applications for two major operational components of the trial: a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC). The CCC is typically responsible for the day-to-day clinical operations across sites, such as site activation, training, recruitment and retention support, intervention delivery oversight, regulatory coordination, adverse event reporting workflows, and ensuring the protocol is implemented consistently. The DCC typically handles data management and quality control, database development, randomization procedures, statistical analysis planning and execution, interim monitoring support, production of reports for oversight bodies, and ensuring data integrity and security. The FOA also allowed, but did not require, separate applications for specialized core functions, such as imaging cores, quality-of-life assessment units, or economic analysis cores, recognizing that some Phase III trials rely on centralized expertise for specialized measurements.
In terms of scope, the announcement was broad: trials could address any research question aligned with NINDS goals and priorities, and applicants were directed to consult the NINDS mission, strategic plan, and research interests available through the NINDS website. That breadth implies the opportunity could cover many neurological areas, provided the proposed study is truly Phase III, multi-site, randomized, and controlled, and is designed to produce practice-relevant evidence about an intervention.
Administratively, this opportunity fell under the "Discretionary" opportunity category and used the "Cooperative Agreement" funding instrument type. The activity category was "Health," and the CFDA number listed was 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). No cost sharing or matching was required, which is typical for NIH research grants and lowers barriers for applicants who might otherwise need non-federal matching funds.
Eligibility was expansive and included many types of domestic and non-domestic organizations. Eligible applicants included state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status (including those other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. It also included independent school districts and public housing authorities/Indian housing authorities, as well as Native American tribal governments (federally recognized) and other tribal organizations. The eligibility information further clarified inclusion of 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, eligible agencies of the federal government, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities. Taken together, this indicates NINDS was open to a wide range of capable institutions, including international partners, as long as they could meet the scientific, ethical, and operational requirements of a large Phase III randomized trial.
The timeline information indicates it was posted on May 14, 2010, with a creation date of March 22, 2011. The original closing date is listed as May 7, 2013, but the current closing date shown in the record is March 21, 2011, with an archive date of April 22, 2011. Practically, that means this specific announcement is no longer active and has been archived, though similar clinical trial funding opportunities may exist under newer NINDS or NIH FOAs. The official full announcement was hosted on the NIH grants site under the provided link, and NIH Office of Extramural Research (OER) webmaster contacts were listed for access or linking issues.
Overall, PAR-10-198 was designed as a structured, NIH-coordinated path for investigators to run definitive, multi-site Phase III randomized controlled trials in neurology under a cooperative agreement model, with a required separation of clinical and data coordination responsibilities to support high-quality trial execution, data integrity, and reliable, actionable results.
Frequently Asked Questions (FAQs)
What is the funding opportunity called and who offered it?
The opportunity is titled "NINDS PHASE III Investigator Initiated Multi Site Clinical Trials (U01)" (Funding Opportunity Number PAR-10-198). It was issued by the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS).
What is the main purpose of PAR-10-198?
The purpose was to provide a clear application pathway for investigator-initiated, multi-site Phase III clinical trials. The intent was to support large, definitive, randomized, controlled trials testing an intervention to answer important questions within the NINDS mission area and generate high-quality evidence that could change clinical practice.
What types of studies were the focus of this FOA?
This FOA focused on late-stage, confirmatory Phase III research, emphasizing rigorous trial design appropriate for Phase III trials where the goal is typically to establish efficacy and safety in a definitive way.
What is the NINDS mission area for studies under this opportunity?
The mission area includes diseases and disorders of the nervous system, stroke, and related neurological conditions. The announcement was broad and could cover many neurological areas as long as the study aligned with NINDS goals and priorities.
Did the FOA require the trial to be multi-site?
Yes. The program was intended for multi-site Phase III clinical trials and was not intended for single-center clinical studies.
Did the FOA require a randomized, controlled design?
The central aim was to support large, definitive, randomized, controlled trials. The description emphasizes participants being assigned (typically randomly) to one or more intervention arms and a control arm, with outcomes measured under a protocol designed to produce high-quality evidence.
What kinds of projects were explicitly not supported?
The FOA was not intended for single-center clinical studies. It was also not intended for multi-center observational studies that do not test an intervention, such as cohort follow-up, natural history data collection, or non-interventional registries.
What funding mechanism was used?
The award mechanism was a U01 cooperative agreement.
What does it mean that this is a U01 cooperative agreement?
A cooperative agreement signals a more collaborative relationship with NIH than a typical investigator-initiated R01 grant. Under this model, NINDS generally expects substantial programmatic involvement, which can include trial oversight, milestone monitoring, and coordination on protocol adherence, recruitment performance, safety monitoring, and data quality.
Were separate applications required for different trial components?
Yes. A distinctive requirement was that NINDS required separate applications for the Clinical Coordinating Center (CCC) and the Data Coordinating Center (DCC).
What is the role of the Clinical Coordinating Center (CCC) in this FOA?
The CCC is typically responsible for day-to-day clinical operations across sites. This can include site activation, training, recruitment and retention support, oversight of intervention delivery, regulatory coordination, adverse event reporting workflows, and ensuring consistent protocol implementation across participating sites.
What is the role of the Data Coordinating Center (DCC) in this FOA?
The DCC typically manages data-related and statistical operations. This can include data management and quality control, database development, randomization procedures, statistical analysis planning and execution, interim monitoring support, preparation of reports for oversight bodies, and ensuring data integrity and security.
Could a trial include additional specialized cores beyond the CCC and DCC?
Yes. The FOA allowed, but did not require, separate applications for specialized core functions such as imaging cores, quality-of-life assessment units, or economic analysis cores.
What categories and instrument types were associated with this opportunity?
The opportunity category was listed as "Discretionary." The funding instrument type was "Cooperative Agreement." The activity category was "Health."
What CFDA number was associated with this funding opportunity?
The CFDA number listed was 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Was cost sharing or matching required?
No. The record indicates no cost sharing or matching was required.
Who was eligible to apply?
Eligibility was expansive and included many types of domestic and non-domestic organizations. Eligible applicants included state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status (including those other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Did eligibility include tribal organizations and U.S. territories?
Yes. Eligibility included Native American tribal governments (federally recognized) and other tribal organizations, as well as U.S. territories or possessions. The list also referenced regional organizations.
Were foreign (non-U.S.) organizations eligible?
Yes. The eligibility information included foreign (non-U.S.) entities.
Did the eligibility language mention specific institution types (for example, HBCUs or Hispanic-serving institutions)?
Yes. The eligibility information referenced 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, and eligible agencies of the federal government.
When was the opportunity posted and what is its status now?
The record indicates it was posted on May 14, 2010, with a creation date of March 22, 2011. It also shows a current closing date of March 21, 2011 and an archive date of April 22, 2011. Practically, this specific announcement is no longer active and has been archived.
Why do the dates in the record look inconsistent (multiple closing dates)?
The record shows an original closing date of May 7, 2013, but also lists a current closing date of March 21, 2011 and an archive date of April 22, 2011. Based on the record as presented, the key takeaway is that the FOA is archived and not currently active.
Where was the official announcement hosted?
The full announcement was hosted on the NIH grants site under the provided link in the record.
Who was listed as a contact for technical issues with the announcement posting?
The NIH Office of Extramural Research (OER) webmaster contacts were listed for access or linking issues.
What overall kind of research pathway did PAR-10-198 represent?
It was designed as a structured, NIH-coordinated path for investigators to run definitive, multi-site Phase III randomized controlled trials in neurology under a cooperative agreement model, with a required separation of clinical and data coordination responsibilities to support high-quality execution, data integrity, and reliable results.
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