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

Notice Number: NOT-DK-10-003

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date:  February 19, 2010

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov/)

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,  (http://grants.nih.gov/grants/guide/notice-files/NOT-DK-07-015.html).

NIDDK will support investigator-initiated, multi-center clinical studies exclusively through a two-part grant process: (1) an implementation planning (U34) grant 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-09-247: Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html), 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 mechanism, through the appropriate program announcements: 

PAR-09-077: Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21), http://grants.nih.gov/grants/guide/pa-files/PAR-09-077.html;
PA-09-151: Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21), http://grants.nih.gov/grants/guide/pa-files/PA-09-151.html
PA-09-133: Pilot and Feasibility Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases (R21), http://grants.nih.gov/grants/guide/pa-files/PA-09-133.html; and
PA-09-124: Exploratory/Developmental Clinical Research Grants in Obesity (R21),  http://grants.nih.gov/grants/guide/pa-files/PA-09-124.html).

Multi-Center Clinical Study Implementation Planning (U34) Grant

 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 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.

All multi-center clinical studies must complete this two-part process. The U34 grant will provide up to two years of support. Pre-approval from NIDDK will be required for submission of an U34 application. 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 grant will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed under the planning grant. Prospective applicants should note that funding of a U34 does not guarantee or imply funding for a subsequent application.

Multi-Center Clinical Study Grant (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. In order not to delay the initiation of the multi-center clinical study (U01), the peer review and award of grant 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 PARs, one for the Multi-Center Clinical Study Implementation planning (U34) Grant (PAR-10-197) and one for the Multi-Center Clinical Study (U01) Grant (http://grants.nih.gov/grants/guide/pa-files/PAR-08-058.html), as well as on the NIDDK website (http://www2.niddk.nih.gov/Research/ClinicalResearch/multicenterclinicalresearch).

Inquiries

Inquiries concerning investigator-initiated, multi-center clinical studies should be sent to:

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 699
6707 Democracy Boulevard
Bethesda , MD 20892-5460
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
Two Democracy Plaza, Room 639
Bethesda , MD 20892-5458
Telephone:   (301) 451-7717
Fax:   (301) 480-3510
Email:  mm726k@nih.gov

Patricia Robuck, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 659
6707 Democracy Boulevard
Bethesda , MD 20892-5450
Telephone:   (301) 594-8872
Fax:   (301) 480-8300
Email: robuckp@mail.nih.gov


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