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


Notice Number:

NOT-DK-14-025

Key Dates

Release Date: December 11, 2014

Related Announcements

NOT-DK-07-015

PAR-15-067

PAR-15-068

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 through a two-part award process: (1) an implementation planning phase 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 centers. 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 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 that specifically invite multi-center applications. 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:

Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (PAR-11-352)

Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (PA-12-139)

Pilot and Feasibility Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases (PA-12-157)

Exploratory/Developmental Clinical Research Grants in Obesity (PA-12-179)

Rationale

When a multi-center clinical study application is funded, extensive administrative planning (e.g., protocol finalization, manual of operations development) is generally required before subject recruitment can occur. These planning activities may consume valuable time and resources. NIDDK believes that a two-part cooperative agreement process that separates administrative implementation from subject recruitment and study conduct will remedy these issues. Therefore, NIDDK will support implementation planning (U34) cooperative agreements 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. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.

Successful completion of an awarded U34 will result in 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. Applicants who feel they have completed all the planning elements without a U34 may apply directly for the U01. Applicants are strongly encouraged to contact NIDDK Scientific/Research staff before submitting a U34 or U01 application. Applicants seeking $500,000 in direct costs in any year (excluding consortium F&A) must contact Scientific/Research staff at least 6 weeks before submitting an application to obtain approval to submit.

Clinical studies proposed should be hypothesis-driven and address diseases relevant to the mission of NIDDK.

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) (PAR-15-068) and one for the Multi-Center Clinical Study Cooperative Agreement (U01) (PAR-15-067), as well as on the NIDDK website.

Inquiries

Please direct all inquiries to:

Marva Moxey-Mims, M.D
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7717
Email:mimsm@mail.nih.gov

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

Jose Serrano, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8871
Email: serranoj@mail.nih.gov