Notice of New NIAMS Policy for Investigator-Initiated Clinical Trials


Notice Number: NOT-AR-11-014

Update: This Notice has expired and has been replaced:

Key Dates

Release Date: March 18, 2011

Issued by

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

Purpose

This Notice informs potential applicants of changes in the NIAMS policies and procedures for the acceptance, peer review, and funding of investigator-initiated clinical trials.

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

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 (UM1). Pilot and feasibility studies to support and enable the initiation of clinical trials will be supported by the R21 mechanism.

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). For trials involving greater numbers of subjects or of greater complexity or risk, investigators should apply for funding through a NIAMS Clinical Trial Implementation Cooperative Agreement (UM1). 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 to implement the trial. The planning grant will allow an investigator to accomplish the planning activities (manual of operating procedures, FDA approvals, etc) which are often necessary for actually implementing a clinical trial; applicants for a Clinical Trial Implementation Cooperative Agreement are expected to be able to begin the trial without further planning activities when the UM1 is awarded. Investigators who have already completed planning activities either by a previously awarded NIAMS U34, R34, or other means may also submit a UM1 implementation grant, but are strongly encouraged to consult with NIAMS staff in advance. Investigators considering applying to the NIAMS for a clinical trial grant should refer to the NIAMS Clinical Trials Policy web site. The program announcements for Pilot and Feasibility Clinical Research Grants (R21), Clinical Trial Planning Grants (U34), and Clinical Trial Implementation Cooperative Agreements (UM1) are available through the links below.

Prior consultation with the NIAMS is strongly encouraged for submission of the NIAMS Clinical Trial Implementation (UM1) 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 presubmission 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.

Applicants are also strongly encouraged to submit a Letter of Intent (LOI) to the NIAMS before submission of an application for either a U34 or a UM1, including new and resubmission applications. Investigators may refer to the NIAMS website 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. 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 Program Announcements for the clinical trials R21, U34 and UM1 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 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 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)

[PAR-11-168]

The product of an awarded U34 planning grant that has met its milestones, as submitted in the application and agreed upon by the Principal Investigator and NIH Program Official, will be an application (UM1) 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 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. Please refer to (NIAMS website) for details as to the planning and administrative tasks that should be complete prior to submitting a UM1 application.

Pre-approval of an application which will have direct costs of $500,000 or more in any given year is required per NIH policy. Applicants should go to (NIAMS website) for information about what to include in their Letter of Request and are encouraged to contact their program director for additional guidance. Investigators should allow enough time before their planned receipt date to give the Instiutte at least 10 weeks to determine whether it will approve the written request to submit the UM1. An approval letter to submit the application may be obtained from the approvpirate 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:

Any applications dealing with mechanistic studies in clinical trials of immunomodulatory interventions for immune-mediated diseases should be submitted to the NIAID Hyperaccelerated Award Program for Ancillary Studies in Immunomodulation Clinical Trials (RFA-AI-10-014) in which the NIAMS is a participating Institute.

Investigators should consider RFA-AR-11-013 for ancillary studies that are exploratory/ developmental and highly innovative in nature and related to the NIAMS mission. Such studies must be in conjunction with privately or publicly funded, large, ongoing clinical projects and meet time-sensitivity requirements.

Effective immediately, the NIAMS will no longer participate in or accept 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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