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Consultation with NIAMS Staff
Updated October 5, 2016
Consultation: Prior to Submission of: Application for Exploratory Clinical Trial Grant (R21), Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01) grant, Clinical Trial Planning (R34) or Clinical Trial Implementation (U01) Cooperative Agreement
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials. The NIAMSís goal is to identify and fund trials that are timely and informative, and that will lead to improvements in clinical practice for disease prevention, diagnosis, and treatment.
The NIAMS clinical trials program is designed to support clinical studies through funding mechanisms tailored to different levels of complexity and risk. Investigators planning short-term studies that involve few subjects and limited duration of follow-up with the goal of collecting experimental data needed to launch a future clinical trial may apply for a NIAMS Exploratory Clinical Trial Grant (R21) or a Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01) grant. For trials involving a larger number of subjects or are of greater complexity, the NIAMS supports investigator-initiated, clinical interventional trials through a Clinical Trial Implementation Cooperative Agreement (U01) to fully implement and conduct the study. Investigators are encouraged to consider applying for a NIAMS Clinical Trial Planning Grant (R34) prior to applying for an U01. The R34 funding mechanism supports the necessary planning, design, and preparation of documentation prior to implementation of investigator-initiated clinical trials.
Investigators are strongly encouraged to consult with the NIAMS prior to submitting an application to any of the NIAMS clinical funding opportunity announcements (FOAs). NIAMS staff will consider whether the proposed clinical project meets the goals and mission of the Institute and whether it is appropriate for an investigator-initiated application, but will not evaluate the technical and scientific merit of the proposal. Technical and scientific merit will be determined during peer review.
If it is determined in the pre-submission stage that the proposal does not meet the goals and mission of the NIAMS, applicants will be informed.
Investigators who anticipate submitting an application to any of the NIAMS clinical FOAs should consider the items below in preparation for a pre-submission consultation with a NIAMS Program Officer.
- Anticipated date of submission
- Study title
- Study PI(s)
- Primary institution and potential collaborating sites
- Brief description of the objectives of the clinical study
- Brief rationale for the proposed clinical study
- Scientific basis/premise
- Clinical significance
- Total cost estimate of the clinical study by year
- Estimated start date and duration of the clinical study
- For applicants intending to submit a Clinical Trial Implementation (U01) grant, complete the Clinical Trial Planning Milestone Checklist that summarizes each of the planning Milestones and provides the status of each task. Any tasks that remain incomplete prior to submitting the U01 application must be detailed and justified but if the application is funded, must be completed before the NIAMS will allow the trial to open for enrollment. Note that there are separate requirements to submit documents as part of Other Attachments for the U01 clinical trial application that are part of the peer review process. Please see PAR 16-447 for more information.
Furthermore, investigators are strongly encouraged to notify the NIAMS prior to submission of the application for either a R34 or a U01 through a Letter of Intent (LOI). Instructions for preparing the LOI are provided in the FOA. LOIs should be submitted to the Scientific/Research contact listed below, who will share the request with the appropriate Program Officer.
Shahnaz Khan, MPH
In addition to technical merit, the NIAMS will consider program priorities in making funding decisions. Applications that do not meet the criteria outlined above or that are judged to be of low program priority will not receive funding even if found to be scientifically sound in peer review. One benefit of consultation prior to submission of an application is that the Program Officer can discuss with the investigator the extent to which the potential project fits with NIAMS program priorities.
The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.
Applications with Direct Costs of $500,000 or Greater in Any Year
Pre-approval is required prior to submission of an application which will have direct costs of $500,000 or more in any given year, as per NIH policy. Applicants should refer to https://www.niams.nih.gov/Funding/Clinical_Research/clinical_letter_request.asp for information about what to include in their Letter of Request (LOR). LORs are due at least 10 weeks prior to the application deadline. Due dates for the LOR are also included in the Milestone Checklist.