Opportunity Information: Apply for PA 09 186
Apply for PA 09 186
- The National Institutes of Health in the education employment, labor and training health income security and social services sector is offering a public funding opportunity titled "NIH Clinical Trial Planning Grant Program (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.209 Contraception and Infertility Research Loan Repayment Program 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research.
- This funding opportunity was created on Nov 2, 2010 and posted on May 15, 2009.
- Applicants must submit their applications by May 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments County governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments For profit organizations other than small businesses 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) 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:
The NIH Clinical Trial Planning Grant Program (R34) is a National Institutes of Health funding opportunity designed to help investigators get a Phase III clinical trial fully ready to launch. The core idea is that NIH will support the intensive planning work that has to happen before a large, definitive trial can begin, so that the eventual Phase III study is operationally sound, well managed, and realistically recruitable. In practice, this means the grant is meant to fund the organizational and technical build-out of the trial rather than the science that would justify doing the trial in the first place.
The activities supported under this R34 are focused on nuts-and-bolts trial preparation. Applicants can use funds to assemble and formalize the full research team and governance structure, clarify roles and responsibilities, and set up the systems needed to run a complex, multi-site effort. The announcement specifically highlights developing tools for data management and trial oversight, which commonly includes items like case report forms, database and data capture plans, quality control processes, safety monitoring approaches, and coordination procedures across sites. It also emphasizes developing and refining recruitment strategies, which generally involves defining the target population, selecting and preparing recruitment sites, creating retention plans, and setting milestones and tracking methods. A central deliverable is a finalized protocol and the other essential operational elements collected into a manual of operations or procedures, so that the trial can proceed with consistent implementation and documentation.
A key limitation of this program is what it does not fund. The R34 planning grant is not intended to collect preliminary data and is not a mechanism for pilot studies that would build the rationale for the clinical trial. In other words, NIH expects that the justification for moving toward a Phase III trial is already in place; the planning grant is meant to reduce avoidable failure risk by making sure the study design, operations, and infrastructure are ready for execution.
From a funding and administrative standpoint, this opportunity uses the NIH R34 mechanism and provides up to $100,000 in direct costs for a one-year project period. Because proposed trials differ widely, NIH notes that the total number of awards and total dollars awarded depend on the number, quality, duration, and costs of the applications received. The application has a strict research plan length limit: the Research Plan portion of the PHS398 (Items 2-5) may not exceed 25 pages, and that page count includes tables, figures, and similar elements.
Eligibility is broad and includes many organization types across academia, government, nonprofit, and industry. Examples listed include public and private institutions of higher education, nonprofits with and without 501(c)(3) status, state, county, city/township, and special district governments, independent school districts, public housing authorities/Indian housing authorities, and for-profit organizations (including small businesses). The announcement also clarifies additional eligible applicants such as certain minority-serving institutions (including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, certain eligible federal agencies, and non-U.S. (foreign) entities.
The FOA allows flexibility in leadership and submissions. Applicants may name more than one project director/principal investigator (multiple PDs/PIs) if that fits the project’s leadership needs, and an applicant organization may submit more than one application as long as each is scientifically distinct. Resubmissions are allowed, but they must include an introduction that directly addresses the prior peer review critique (the Summary Statement). Renewal applications are not permitted, reflecting the one-time, planning-focused nature of the award. NIH also encourages applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities, consistent with NIH-wide efforts to broaden participation in biomedical research leadership.
For reference, the opportunity is listed as Funding Opportunity Number PA-09-186, titled “NIH Clinical Trial Planning Grant Program (R34),” administered by the National Institutes of Health. It was originally posted May 15, 2009, with a closing date of May 7, 2012, and it is now archived (archive date June 7, 2012). It is associated with multiple CFDA program areas (including research related to communication disorders, alcohol and drug abuse research, arthritis and musculoskeletal research, child health and human development research, and aging research), indicating that the planning mechanism can support Phase III trial development across a wide range of NIH mission areas rather than being limited to a single disease domain.
FAQs: NIH Clinical Trial Planning Grant Program (R34) - PA-09-186
What is the NIH Clinical Trial Planning Grant Program (R34)?
The NIH Clinical Trial Planning Grant Program (R34) is a National Institutes of Health funding opportunity intended to support the intensive planning work needed to get a Phase III clinical trial fully ready to launch. The emphasis is on operational readiness (how the trial will be run) rather than generating new scientific justification for doing the trial.
What is the main purpose of this R34 planning grant?
The main purpose is to reduce avoidable failure risk for large, definitive Phase III trials by funding the organizational and technical build-out required before trial initiation. The goal is a trial that is operationally sound, well managed, and realistically recruitable.
Does this program fund the actual Phase III clinical trial?
No. This mechanism is for planning and preparation activities that occur before a Phase III trial starts. It is meant to produce the final protocol and core operational materials needed to proceed consistently across sites.
What kinds of activities does the R34 support?
Supported activities focus on practical trial preparation, including assembling and formalizing the research team and governance structure; defining roles and responsibilities; building data management and trial oversight tools; refining recruitment and retention strategies; and establishing coordination procedures across sites.
What does NIH mean by "nuts-and-bolts" trial preparation?
In this context, "nuts-and-bolts" refers to operational planning tasks such as creating case report forms, planning databases and data capture, designing quality control processes, defining safety monitoring approaches, setting up trial oversight procedures, and planning multi-site coordination.
What recruitment-related work can be supported under this R34?
The FOA highlights developing and refining recruitment strategies, which commonly includes defining the target population, selecting and preparing recruitment sites, creating retention plans, and setting milestones and tracking methods to monitor recruitment progress.
What are the expected deliverables from this planning grant?
A central deliverable is a finalized clinical trial protocol along with other essential operational elements compiled into a manual of operations or manual of procedures. This is intended to support consistent implementation and documentation when the Phase III trial begins.
Can R34 funds be used to collect preliminary data?
No. This planning grant is not intended to collect preliminary data.
Is this R34 a mechanism for pilot studies?
No. The R34 planning grant is not designed to support pilot studies that build the rationale for a future clinical trial. NIH expects that the justification for moving toward a Phase III trial is already in place.
How much funding is available under this R34 opportunity?
The opportunity provides up to $100,000 in direct costs for a one-year project period.
What is the project period for this R34?
The project period is one year.
How many awards will NIH make under this funding opportunity?
The total number of awards and total dollars awarded depend on the number, quality, duration, and costs of the applications received.
What is the Research Plan page limit?
The Research Plan portion of the PHS398 (Items 2-5) may not exceed 25 pages, and this page count includes tables, figures, and similar elements.
Who is eligible to apply?
Eligibility is broad and includes a wide range of organization types across academia, government, nonprofit, and industry, as well as certain non-U.S. (foreign) entities.
What types of organizations are listed as examples of eligible applicants?
Examples include public and private institutions of higher education; nonprofits with and without 501(c)(3) status; state, county, city/township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; and for-profit organizations (including small businesses).
Are minority-serving institutions eligible?
Yes. The announcement lists certain minority-serving institutions as eligible, including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.
Are faith-based or community-based organizations eligible to apply?
Yes. The FOA explicitly includes faith-based or community-based organizations among eligible applicant types.
Are U.S. territories or possessions eligible?
Yes. The FOA notes eligibility for U.S. territories or possessions.
Are federal agencies eligible?
The announcement indicates that certain eligible federal agencies may apply.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The FOA includes non-U.S. (foreign) entities among eligible applicants.
Can an application include multiple Project Directors/Principal Investigators (PDs/PIs)?
Yes. Applicants may designate more than one PD/PI (multiple PDs/PIs) if that structure fits the project’s leadership needs.
Can an organization submit more than one application?
Yes. An applicant organization may submit more than one application as long as each application is scientifically distinct.
Are resubmissions allowed?
Yes. Resubmissions are allowed, but they must include an introduction that directly addresses the prior peer review critique (the Summary Statement).
Are renewal applications permitted under this FOA?
No. Renewal applications are not permitted, reflecting the one-time, planning-focused nature of the award.
Does NIH encourage applications from underrepresented groups?
Yes. NIH encourages applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities, consistent with NIH-wide efforts to broaden participation in biomedical research leadership.
What is the Funding Opportunity Number and title for this program?
The Funding Opportunity Number is PA-09-186, titled "NIH Clinical Trial Planning Grant Program (R34)."
Which agency administers this opportunity?
This funding opportunity is administered by the National Institutes of Health (NIH).
Is this funding opportunity still open?
No. The opportunity is archived. It was originally posted May 15, 2009, had a closing date of May 7, 2012, and an archive date of June 7, 2012.
Is this R34 limited to one disease area or NIH mission area?
No. The opportunity is associated with multiple CFDA program areas (including communication disorders, alcohol and drug abuse, arthritis and musculoskeletal conditions, child health and human development, and aging), indicating it can support Phase III trial development across a wide range of NIH mission areas.
What does it mean that the R34 focuses on operations rather than justification?
It means the grant is aimed at funding planning and infrastructure work (protocol finalization, manuals, data and oversight systems, recruitment planning, governance setup) rather than studies designed to prove the trial should be done. NIH expects the scientific rationale for the Phase III trial to already exist.
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