Notice of Updated NIAMS Policy for Investigator-Initiated Clinical Trials


Notice Number: NOT-AR-11-020

Key Dates

Release Date:  July 14, 2011  

Related Notices

NOT-AR-11-014

Issued by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

This Notice informs potential applicants of updates to recent changes in the NIAMS policies and procedures for the acceptance, peer review, and funding of investigator-initiated clinical trials. It replaces expired NOT-AR-11-014, and includes information about the recently published U01 FOA (see below). This U01 FOA, which allows for the electronic submission of applications for single-site projects, complements the previously released UM1 FOA, which permits submission of paper applications for multi-site projects.

Overview

The NIAMS is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials that lead to better clinical outcomes.  The NIAMS’ goal is to identify and fund trials that are as timely and informative as possible, and which will lead to improvements in clinical practice for disease prevention, diagnosis, and treatment.  To this end, the NIAMS has enhanced its clinical trials program.

Background

Clinical trials range from small first-in-human or tolerability studies to larger trials of efficacy or effectiveness. The NIAMS has redesigned its clinical trials program in order to support the spectrum of such studies with funding mechanisms tailored to different levels of complexity. Investigators planning trials that involve few subjects and limited duration of follow-up may apply for a NIAMS Pilot and Feasibility Clinical Research Grant (R21).   Proposed studies should focus on research questions that are likely to gather critical preliminary data in support of a future, planned clinical trial or to benefit clinical research and trials more broadly.

For trials involving greater numbers of subjects or of greater complexity or risk, the NIAMS will support investigator-initiated clinical trials through a two part grant process: 1) a clinical trial planning grant (U34) followed by, 2) a clinical trial implementation cooperative agreement, as either a UM1 for a multi-site trial or U01 for a single site trial.  These larger and more complex trials require substantial planning and preparation prior to opening for recruitment, and investigators are expected to apply for a NIAMS Clinical Trial Planning Grant (U34) prior to submitting an application for the UM1 or U01 to implement the trial.  The planning grant will allow an investigator to accomplish the planning activities (manual of operating procedures, FDA approvals, etc) that are often necessary for implementing a clinical trial.

Applicants for a Clinical Trial Implementation Cooperative Agreement (UM1 or U01) are expected to be able to begin the trial without further planning activities when the grant is awarded.   Investigators who have already completed planning activities, either by a previously awarded NIAMS clinical trial planning grant (U34 or R34) or other means, may also submit a UM1 or U01 implementation grant, but are strongly encouraged to consult with NIAMS staff in advance.

Prior consultation with the NIAMS is strongly encouraged for submission of the NIAMS Clinical Trial Implementation Cooperative Agreement (UM1 or U01) grant application, including new and resubmission applications.  NIAMS staff will consider whether the proposed clinical trial meets the goals and mission of the Institute and whether it is appropriate to conduct it as an investigator-initiated clinical trial, but will not evaluate the technical and scientific merit of the proposed trial.  Technical and scientific merit will be determined during peer review.  In the pre-submission consultation phase, if the proposed trial does not meet the goals and mission of the NIAMS, applicants will be so informed.  If the NIAMS ascertains that substantial additional planning may be necessary, submission of the application may be considered under the Clinical Trial Planning Grant (U34) Cooperative Agreement FOA (PAR-11-169).  The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.  

How to Apply

Investigators considering applying to the NIAMS for a clinical trial grant should refer to the NIAMS Clinical Trials Policy web site. The funding opportunity announcements (FOAs) for Pilot and Feasibility Clinical Research Grants (R21), Clinical Trial Planning Grants (U34), and Clinical Trial Implementation Cooperative Agreements (UM1 or U01) are available through the links below. 

Applicants are also strongly encouraged to submit a Letter of Intent (LOI) to the NIAMS before submission of an application for a U34, UM1, or U01, including new and resubmission applications.  Investigators may refer to the NIAMS website, contact the scientific research contacts, or consult the appropriate FOA for details on the information to be included in the LOI.  Applicants are encouraged to allow enough time before the planned receipt date to give the Institute at least 10 weeks, particularly if there has been no prior consultation with the NIAMS about the application. The LOI should be submitted to the Scientific/Research contacts listed in the FOA, who will share the request with the appropriate Program Official.  

Peer review of properly completed applications submitted in response to the FOAs for the clinical trials R21, U34, UM1 and U01 will be conducted by the NIAMS Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee (AMSCT).

Pilot and Feasibility Clinical Research Grants (R21)

PAR-10-282

The Pilot and Feasibility Clinical Research Grants are designed to allow initiation of exploratory, short-term clinical studies in support of the development of clinical trials, using a mechanism to facilitate the development of new ideas which may be investigated without stringent requirements for preliminary data. Proposed studies should focus on research questions that are likely to gather critical preliminary data in support of a future, planned clinical trial or to benefit clinical research and trials more broadly, such as by demonstrating the feasibility of a recruitment target or approach, obtaining data in support of potential inclusion and exclusion criteria, or to gather preliminary evidence of efficacy, tolerability and/or toxicity of an available drug, biologic or device in a new population relevant to the NIAMS mission.

NIAMS Clinical Trial Planning Grants (U34)

[PAR-11-169]

The U34 grant will provide support to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, develop and finalize the clinical protocol and all essential elements of the study required for the clinical trial. The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial. The NIAMS R21 FOA (see above) will support pilot and feasibility studies.

It is expected that receipt of a U34 grant will lead to the timely submission of an application for support of the appropriate clinical trial, incorporating the elements developed under the planning grant. The U34 application should propose planning and administrative tasks that, when accomplished, will serve as indicators of progress in the planning phase. The NIAMS will consult with the investigators prior to any award to identify specific milestones (see NIAMS clinical trial milestones website). Once certain, pre-specified milestones are met, the investigators may consider submission of an application for a UM1 or U01 to support implementation of the clinical trial. However, prospective applicants should note that receipt of a Clinical Trial Planning Grant award does not guarantee or imply funding for a subsequent clinical trial implementation application.

NIAMS Clinical Trial Implementation Cooperative Agreements (UM1 or U01)

[PAR-11-168]

PAR-11-219

The product of an awarded U34 planning grant that has met its milestones, as submitted in the application and agreed upon by the PD/PI and NIAMS Program Official, will be an application (UM1 or U01) to conduct the clinical trial, which incorporates the elements developed under the planning grant.

The NIAMS will only consider funding applications for implementation of investigator-initiated clinical trials from U34 awardees, unless the necessary pre-trial tasks have been completed through a R34 or other means and it is clear that the trial implementation can begin when the UM1 or U01 is awarded. In cases where an applicant has not carried out the planning activities with the support of a NIAMS U34, investigators are strongly encouraged to discuss the potential clinical trial with the Program Director well in advance of submitting the application for a UM1 or U01. Please refer to the NIAMS website for details as to the planning and administrative tasks that should be complete prior to submitting a UM1 or U01 application.

Applicants must seek NIAMS agreement to accept an application which will have direct costs of $500,000 or more in any given year per NIH policy. Applicants should go to the NIAMS website for information about what to include in their Letter of Request and are encouraged to contact their Program Official for additional guidance. Investigators are encouraged to allow enough time before the planned receipt date to give the Institute at least 10 weeks to determine whether it will approve the written request to submit the UM1 or U01. An approval letter to submit the application may be obtained from the appropriate NIAMS Division Director and should be included with the application.

A clinical trial implementation cooperative agreement application should describe all necessary components to successfully conduct a clinical trial. Implementation support is defined as support for activities related to the conduct of the clinical trial.

Other FOAs:

As of 18 March 2011, the NIAMS no longer participates in or accepts applications submitted under PA-09-186, NIH Clinical Trial Planning Grant Program (R34).

This policy does not cover clinical trial applications in response to a Request for Applications (RFA), which will follow the guidelines and instructions in the Funding Opportunity Announcement (FOA).

Inquiries

Please direct all inquiries to:

Shahnaz Khan, MPH
Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 810
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 594-2463
Fax: (301) 480-4543
Email: khanshah@mail.nih.gov

or

Anna Nicholson
Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 808
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 594-2463
Fax: (301) 480-2463
Email: nicholsona@mail.nih.gov


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