Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) | PAR 18 630

FAQs: Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) (PAR-18-630)

What is this funding opportunity?

This is an NIH grant program titled "Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)" (FOA: PAR-18-630). It supports investigator-initiated, hypothesis-driven clinical trials that require an extended timeline beyond a standard award, using the R01 mechanism.

What is the main purpose of PAR-18-630?

The purpose is to support the implementation of clinical trials that genuinely need a longer project period to complete. The emphasis is on running (implementing) a rigorous, hypothesis-based trial that cannot reasonably be completed within a typical project period.

What makes this FOA different from a typical NIH R01 clinical trial opportunity?

The defining feature is the extended project period requirement. Applicants must propose a clinical trial that requires 6 or 7 years to complete. The extended duration is not a preference; it is a necessity that must be justified.

How long can the project period be under this opportunity?

The clinical trial proposed must require a 6- or 7-year timeline to complete. This extended duration is central to the intent of the announcement.

Do applicants have to justify why the trial needs 6 or 7 years?

Yes. The FOA is specifically intended for trials where the extended duration is required by scientific and operational realities. Applicants should be able to justify why the work cannot reasonably be completed in a typical project period.

What are examples of reasons a trial might need 6 or 7 years?

Examples mentioned include longer follow-up needs, complex recruitment, longitudinal outcomes, or other design elements that make a 6- or 7-year period appropriate.

Is this opportunity for clinical trial planning or for clinical trial implementation?

The key expectation is that the application focuses on trial implementation, not just planning. The FOA is aimed at executing the clinical trial work that needs the extended timeline.

What type of clinical trials are allowed (phase limitations)?

The FOA is open to clinical trials in any phase, as long as the proposed trial aligns with the scientific mission of one of the participating NIH Institutes and Centers (ICs).

Does the clinical trial have to be hypothesis-driven?

Yes. The opportunity is described as supporting investigator-initiated, hypothesis-driven clinical trials. The proposed study should be structured around a clear, testable hypothesis.

Does my trial have to align with a particular NIH Institute or Center?

Yes. Alignment with the scientific mission of one of the participating NIH Institutes and Centers (ICs) is essential for fit under this FOA.

Should applicants contact NIH program staff before applying?

Yes. The FOA strongly encourages prospective applicants to consult with NIH program staff before submitting. This helps confirm eligibility, ensure mission alignment, and reduce the risk of submitting an application that does not match the FOA intent.

Why is consulting with NIH program staff emphasized so heavily?

Because two elements are central to the FOA: (1) fit with an NIH IC mission and (2) a convincing justification that the clinical trial truly requires a 6- or 7-year project period. Talking with program staff can help address both before submission.

Who is the sponsor of this funding opportunity?

The sponsor is the National Institutes of Health (NIH).

What grant mechanism/activity code is used?

This opportunity uses the R01 activity and is described as a discretionary grant mechanism in the health funding area.

Is a clinical trial required under this FOA?

Yes. The title explicitly indicates "Clinical Trial Required," and the description centers on supporting the implementation of an investigator-initiated clinical trial.

Is this FOA meant for trials that could be completed in a typical project period?

No. The FOA is specifically not meant for clinical trials that can reasonably be completed in a typical project period. The longer duration must be necessary, not merely desirable.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.855, 93.859, and 93.866.

What is known about the award amount or funding cap?

The provided information does not list an award ceiling or the expected number of awards. It notes that applicants should typically expect NIH R01 budget principles to apply, with budgets justified by the scope and needs of the trial.

How should applicants think about the budget for this FOA?

Based on the information provided, budgets should be justified by the scope and needs of the clinical trial, and applicants should typically expect NIH R01 budget principles to apply.

What was the closing date shown for this listing?

The original closing date shown in the source data is March 9, 2020.

When was the FOA record created?

The FOA record creation date is February 5, 2018.

Is this opportunity potentially outdated for new applicants today?

The dates provided indicate the specific listing is time-bound. The information suggests that anyone looking to apply now may need to check for reissues, updates, or successor announcements.

What types of organizations are eligible to apply?

Eligibility is broad and includes (as described): state, county, city or township, and 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 (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other organizations.

Are minority-serving institutions explicitly included as eligible?

Yes. The FOA explicitly highlights 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), and Tribally Controlled Colleges and Universities (TCCUs) as eligible groups.

Are faith-based and community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted among eligible groups.

Can federal agencies apply?

Yes. Eligible federal agencies are listed among the explicitly highlighted eligible groups.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-domestic (non-U.S.) entities/foreign organizations are explicitly included in the eligibility description provided.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly highlighted as eligible.

Are tribal governments other than federally recognized entities included?

Yes. The eligibility description explicitly includes Indian/Native American Tribal Governments other than federally recognized entities, and also includes tribal organizations (including those other than federally recognized governments).

What kind of research does this program ultimately support?

It supports rigorous, investigator-driven clinical trial research that needs an unusually long runway to execute properly, centered on a clear hypothesis and aligned with an NIH Institute or Center mission.