Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34) | Apply Online

Frequently Asked Questions (FAQs)

What is the Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34) opportunity?

This is an NIH funding opportunity (RFA-HL-12-023) issued by the National Heart, Lung, and Blood Institute (NHLBI) to support intensive early planning work for multicenter clinical trials in rare thrombotic (clotting) and hemostatic (bleeding) disorders. The U34 is designed to fund the planning and development needed to produce a strong, feasible, trial-ready protocol and related materials.

Is this funding intended to pay for running the full clinical trial?

No. The U34 mechanism is specifically described as supporting planning rather than the full conduct of a clinical trial. The award is meant to fund the groundwork that turns a promising question into a realistically recruitable, scientifically rigorous, operationally workable multicenter trial plan, with the intent of positioning the team for a subsequent larger clinical trial award.

What types of diseases or conditions are the focus of this FOA?

The focus is on rare thrombotic and hemostatic disorders (rare clotting and bleeding disorders). The opportunity is centered on the planning needs that are especially challenging in rare disorders due to small patient populations, limited centers with specialized expertise, less standardized endpoints, and uncertain recruitment feasibility.

Why does this program emphasize planning for rare disorders?

According to the opportunity description, planning is often harder in rare disorders because patient populations are small, expertise is concentrated at a limited number of centers, outcomes and endpoints may be less standardized, and recruitment feasibility can be uncertain. The U34 aims to reduce avoidable delays and trial failure by resolving key design and execution questions before large-scale trial costs begin.

What kind of work does the U34 planning period support?

The U34 is intended to support high-effort planning tasks needed to launch a feasible multicenter trial. Examples described include defining the target population, selecting clinically meaningful endpoints, developing the statistical analysis plan, establishing data and safety oversight approaches, harmonizing procedures across sites, and anticipating regulatory and operational requirements.

What are the expected deliverables from a U34 award?

While the FOA description is not presented as a deliverables checklist, it describes planning outputs such as protocol development, manuals of operation, regulatory planning, site coordination plans, and other trial-ready documents and plans that prepare a study to move into a larger clinical trial award.

What does "multicenter clinical trial" mean in the context of this U34?

In this context, it refers to a clinical trial intended to be conducted across multiple clinical sites. The U34 supports planning to ensure the trial is operationally workable across those sites, including harmonized procedures and coordination planning.

What is the funding instrument for this opportunity?

The funding instrument is a cooperative agreement (U34). This structure is described as involving a more cooperative, hands-on relationship than a standard research grant, with NHLBI and a designated development resource expected to provide guidance during the planning period.

What makes this a cooperative agreement rather than a standard grant?

The FOA description indicates that, during the U34 period, investigators should expect hands-on guidance typical of a cooperative agreement. NHLBI and the designated Clinical Trials Development Resource are expected to be more actively involved in areas like trial design, biostatistics, trial management, and regulatory requirements to strengthen the final protocol and improve trial readiness.

What is the Clinical Trials Development Resource for Hematologic Disorders (U24), and how does it relate to the U34?

A key feature described is built-in support from the Clinical Trials Development Resource for Hematologic Disorders (U24; RFA-HL-12-016). During the U34 funding period, this U24 resource is expected to provide guidance to investigators on trial design, biostatistics, clinical trial management, and regulatory requirements.

How much funding is available under this program overall?

The estimated total funding amount listed for the program is $7,200,000.

What is the maximum award amount for an individual U34 planning award?

The award ceiling is listed as $225,000, reflecting that individual awards are relatively modest and oriented toward planning deliverables rather than enrolling and treating large numbers of participants.

Is cost sharing or matching required?

No. The opportunity explicitly states there is no cost sharing or matching requirement.

What is the CFDA number and program category for this opportunity?

The opportunity is listed under CFDA 93.839 (Blood Diseases and Resources Research). It falls under the health activity category and is categorized as discretionary funding.

Who is eligible to apply?

Eligibility is broad across U.S.-based public and private sectors. Eligible applicants include multiple levels of government (state, county, city or township), special district governments, independent school districts, and public housing authorities/Indian housing authorities. Eligible applicants also include public and private institutions of higher education, nonprofit organizations (whether or not they have 501(c)(3) status, with exceptions as noted in the eligibility list), small businesses, and for-profit organizations other than small businesses.

Are tribal entities eligible?

Yes. The eligibility language explicitly includes federally recognized Native American tribal governments and other tribal organizations, as well as tribally controlled colleges and universities.

Are U.S. territories or possessions eligible?

Yes. The eligibility language explicitly includes U.S. territories or possessions.

Are minority-serving or community-based institution types included in the eligibility language?

Yes. The eligibility language explicitly includes a range of institution types and community-based entities, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities, faith-based or community-based organizations, and regional organizations.

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

No. Foreign (non-U.S.) entities are not eligible to apply.

Can a U.S. organization include foreign components in its project?

Yes. While foreign entities are not eligible to apply, foreign components of U.S. organizations are allowed. This can be relevant for rare disorders where expertise or patient populations may involve international collaborators under a U.S.-led application.

When was this FOA posted, and what were the closing dates?

The FOA was posted on May 2, 2011. The original closing date is listed as October 17, 2013, and the current closing date is listed as November 1, 2013.

Is this funding opportunity still open?

No. The archive date is December 1, 2013, indicating that this specific announcement is no longer open.

Where can applicants find the official FOA announcement details?

The official announcement link provided is http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-023.html.

Who is listed as the contact for access or technical issues with the electronic announcement?

For access or technical issues, the contact listed is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

What is the practical "plain terms" purpose of this U34?

In plain terms, this U34 is described as support for assembling the full blueprint of a rare-disease multicenter trial: clarifying the study question and design, confirming feasibility, aligning multiple clinical sites around consistent procedures, and producing trial-ready documents and plans with expert input on statistics, operations, and regulatory strategy.

Does the U34 guarantee future funding for the full trial?

The provided description does not state or imply a guarantee. It describes the intent as preparing projects to be ready to move into a larger clinical trial award once the design is solid, and to make a subsequent trial application and launch more likely to succeed.