Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies

Notice Number: NOT-DK-13-013

Key Dates
Release Date: July 3, 2013

Related Announcements
NOT-DK-07-015
PAR-12-265
PAR-11-352
PA-12-139
PA-12-157

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This Notice is intended to clarify NIDDK policies and procedures for the acceptance, peer review, and funding of investigator-initiated, multi-center clinical studies, initially described in NOT-DK-07-015 "New NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies." 

NIDDK will support investigator-initiated, multi-center clinical studies exclusively through a two-part grant process: (1) an implementation planning U34 followed by (2) a cooperative agreement (U01) to conduct the study. This policy applies to all clinical studies, interventional trials as well as observational studies, conducted at three or more sites. NIDDK will not accept applications for multi-center clinical studies that are submitted as R01s, with the exception of ancillary studies to existing cooperative agreements, which can be submitted as R01s to PAR-12-265 "Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)" or applications submitted in response to other future FOAs. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 activity code, through the appropriate funding opportunity announcements: 

PAR-11-352 "Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)"
PA-12-139 "Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21)" PA-12-157 "Pilot and Feasibility Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases (R21)"
PA-12-179 "Exploratory/Developmental Clinical Research Grants in Obesity (R21)"

Multi-Center Clinical Study Implementation Planning Grant (U34)
NIDDK will support implementation planning U34 grants for multi-center clinical studies. The U34 is a cooperative agreement award mechanism, with the NIH staff being substantially involved as a partner with the Program Director/Principal Investigator. The U34 is designed to provide early peer review of the rationale and design of the proposed clinical study and 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 and the protocol, as well as a detailed budget for the proposed trial to be conducted through the subsequent U01.

All multi-center clinical studies must complete this two-part process. The U34 cooperative agreement 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.

The product of an awarded U34 will be an application (U01) to conduct the clinical study. It is expected that receipt of a U34 award will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed under the U34 grant. Prospective applicants should note that funding of a U34 grant does not guarantee or imply funding for a subsequent U01 application.

Consultation with the appropriate Program Director/Principal Investigator is strongly encouraged prior to 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.

Multi-Center Clinical Study Cooperative Agreement (U01)
NIDDK will accept, peer review, and consider for funding applications for multi-center clinical studies only from U34 awardees, except in cases where an exemption from this requirement has been provided by NIDDK. An exemption may be requested by investigators who believe that they have completed all the steps which would normally be conducted during the U34 award. In order not to delay the initiation of the multi-center clinical study (U01), the peer review and award of grant applications will be completed within four months of the receipt of the application when possible.

More detailed instructions regarding the multi-center clinical study application process are contained in two FOAs, one for the Multi-Center Clinical Study Implementation Planning Cooperative Agreement (U34) and one for the Multi-Center Clinical Study Cooperative Agreement (U01;  http://grants.nih.gov/grants/guide/pa-files/PAR-11-157.html ), as well as on the NIDDK website:  http://www2.niddk.nih.gov/Research/ClinicalResearch/mcstudies.  The NIDDK website also contains instructions regarding the U34 exemption process.

Inquiries

Please direct all inquiries to:

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone:   (301) 594-0021
Fax:   (301) 480-3503
Email: linderb@mail.nih.gov

Marva Moxey-Mims, M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone:   (301) 451-7717
Fax:   (301) 480-3510
Email:  mm726k@nih.ogv

Mary Horlick, M.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, MD 20892-5450
Telephone:   (301) 594-4726
Fax:   (301) 480-8300
Email: horlickm@mail.nih.gov

 


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