U34 Multi-center Clinical Study Implementation Planning Cooperative Agreement
NIDDK supports investigator-initiated, multi-center clinical studies through a two part process:
- An implementation planning phase, followed by
- A U01 cooperative agreement to conduct the study
This policy applies to all clinical studies, interventional trials as well as observational studies, conducted at three or more sites. A study is considered to be "multi-center" if three or more sites are involved in the actual conduct of the study. A study will not be considered to involve multiple centers if participant recruitment occurs at three or more locations in a geographic area but all interventions and/or outcomes assessments are performed by a single study team.
NIDDK supports implementation planning cooperative agreements (U34) for multi-center clinical studies. The U34 is intended to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing the tools for data management and oversight of the research, defining the recruitment strategies, finalizing the protocol and investigators brochure, writing the Manual of Operations, establishing a data and safety monitoring plan and initiating the IRB approval process. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The U34 application will include the proposed study design, a full protocol and a budget for the clinical study to be conducted under the U01.
The U34 will provide up to two years of support. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.
Prior consultation with the appropriate Program Director is strongly encouraged at least 12 weeks before the submission of a U34 application. Program staff will help the investigator understand whether the proposed full clinical study addresses a high priority research area and meets programmatic needs including balance across research areas, whether it is appropriate to conduct using this mechanism, and whether funds might be available for the subsequent, full clinical study.
A successful U34 will result in an application (U01) to conduct the clinical study. It is expected that receipt of a U34 will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed during the planning phase. Prospective applicants should note that funding of a U34 does not guarantee or imply funding for a subsequent application.
How to Apply
It is expected that you will speak with an NIDDK program director if you are considering submitting a multi-center clinical study implementation planning (U34) application (PAR-15-068)
. Program staff will help the investigator understand whether the proposed full clinical study addresses a high priority research area and meets programmatic needs including balance across research areas, whether it is appropriate to conduct using this mechanism, and whether funds might be available for the subsequent, full clinical study.
You should contact the appropriate Program Director at least 12 weeks before the desired receipt date. Since this is a cooperative agreement, NIDDK will ultimately have substantive scientific involvement with the proposed project. NIDDK will need sufficient time to thoroughly consider the proposed study. It is the Institute’s experience that applications for multi-center clinical studies may be scientifically meritorious but often need further work before they are ready for submission. Allowing as much time as possible for the consultation process will allow time for revisions, should they need to be made.
Your written request for prior consultation should be as succinct as possible. The details included in your letter may vary depending on the type of study planned (e.g., epidemiology study, drug trial, behavior intervention). Generally, the letter should include all of the following items:
- Date of Proposed Submission
- Study title
- Study PI (including biosketch)
- Primary institution
- Specific Aims
- Summary of study protocol, including flow diagram depicting study
- Summary of safety/risk issues
- Proposed start date, duration, and timeline of the clinical trial
- Estimated sample size including brief power calculation
- General statistical assumptions for the proposed study design and analysis
- Potential collaborating sites, including the demographics and availability of the study population at those sites. Include identification and a brief description of the Data Coordinating Center
- Discussion of product/intervention to be evaluated and how it will be obtained, if applicable, including industry partner(s) and regulatory issues that have/need to be resolved
- Total cost for the U34 phase
- Total cost estimate of the clinical study, not the planning grant, by year
- Milestones to be accomplished during the U34
More detailed instructions regarding the U34 application process are contained in the following program announcement: PAR-15-068
The U34 at the NIDDK
The NIDDK U34 is intended to support all administrative study group activities that are required in order to begin recruitment of subjects. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. Investigators who are interested in obtaining support for pilot studies may use the R21 mechanism, through the appropriate program announcement:
View U34 and other Current Funding Opportunities