The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials range from small first-in-human, tolerability or exploratory studies, to larger trials of efficacy or effectiveness.
Learn about NIAMS policies and procedures for investigators conducting clinical research, including short-term and long-term clinical studies.
Types of Clinical Research Grants
Exploratory Clinical Trial Grants (R21)
This Exploratory Clinical Trials Grants Program is designed to facilitate the execution of short-term, interventional studies. Such studies must meet the NIH definition of a clinical trial and be feasible within the time and budget constraints of this Funding Opportunity Announcement (FOA). A high priority is the use of such studies to stimulate the translation of promising research developments from laboratory, preclinical, and early human testing into clinical practice.
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)
Applicants are encouraged to propose studies that address significant obstacles or questions in the design of a clinical trial, such as determining appropriate outcome measures, or identifying when patients are most likely to respond to an intervention.
NIAMS Clinical Trial Planning Grants (R34)
The R34 planning grants will give investigators the time and funds necessary to complete detailed clinical trial planning to meet NIAMS and NIH standards and regulatory requirements.
NIAMS Clinical Trial Implementation Cooperative Agreement (U01)
The U01 implementation cooperative agreement is for applicants that have completed the necessary pre-trial planning activities and are ready to launch the clinical trial.
NIAMS Consultation
Investigators should contact the appropriate NIAMS Program Director prior to submitting applications for a NIAMS Exploratory Clinical Trial (R21) grant, a NIAMS Clinical Observational (R01) grant, a NIAMS R34 clinical trial planning grant or a U01 implementation grant application. Applicants should refer to our Consultation with NIAMS Staff for details on additional information they might wish to share with the Program Director in a pre-submission consultation.
Letter of Intent/Letter of Request
Letter of Intent: Applications with Direct Costs Less Than $500,000
All investigators considering applying for a R34 or a U01 with budgets less than $500,000 in any given year are strongly encouraged to submit a Letter of Intent (LOI) to the NIAMS before submission of the application, including new and resubmission applications. Applicants are encouraged to allow enough time before the planned receipt date to give the Institute sufficient time to discuss the LOI with the investigators, particularly if there has been no prior consultation with the NIAMS about the application. Please see instructions about deadlines and what to include in the LOI. The LOI should be submitted to the Scientific/Research contacts listed in the Program Announcement, who will share the request with the appropriate Program Director.
Letter of Request: Applications with Direct Costs $500,000 or More
Per NIH policy, pre-approval is required prior to submission of an application that will have direct costs of $500,000 or more in any given year. Applicants should refer to NIAMS specific guidelines for information about deadlines and what to include in their Letter of Request (LOR) seeking permission to submit an application. Potential applicants must submit the LOR at least 10 weeks prior to the application due date to determine whether the Institute will approve the written request to submit a U01. The NIAMS will not evaluate the technical and scientific merit of the proposed trial at this stage. Technical and scientific merit will be determined during peer review. Applicants whose projects do meet NIAMS’ programmatic needs or are not considered to be appropriate as investigator-initiated clinical trials will not be granted permission to submit an application. Pre-approval by NIAMS, on the basis of an LOR submitted prior to the application, indicates that NIAMS has determined that the proposed project is of high priority. The NIAMS will inform the applicant of the decision.
| U01 Application Due Date | Letter of Request (LOR) Due Date (required 10-weeks prior to the application due date) |
|---|---|
| March 4, 2021 | December 24, 2020 |
| July 2, 2021 | April 23, 2021 |
| November 2, 2021 | August 24, 2021 |
| March 4, 2022 | December 24, 2021 |
| July 1, 2022 | April 22, 2022 |
| November 4, 2021 | August 24, 2022 |
| March 3, 2023 | December 23, 2022 |
| July 2, 2023 | April 23, 2023 |
| November 3, 2023 | August 25, 2023 |
Peer Review by AMS Clinical (AMSC) Trials Review Committee
Peer review of properly completed applications submitted in response to the Program Announcements listed on this page will be conducted by the NIAMS AMS Clinical Trials Review Committee. This review committee will provide expertise in NIAMS disease areas and in clinical trial methodology.
The NIAMS will make funding decisions on investigator-initiated clinical trials applications with meritorious scores based on programmatic priority. Those judged to have low program priority, or that fail to meet the criteria outlined above, will not receive funding, even if found to be scientifically sound in peer review.
NIAMS Participation in other Clinical Trial Funding Opportunity Announcements (FOAs)
Mechanistic Clinical Trials
The NIAMS will only accept clinical trial applications proposing mechanistic studies in response to these funding opportunities. A mechanistic study is defined as one designed to understand a behavioral or biological process, the pathophysiology of a disease, or the mechanism of action of an intervention. If a clinical trial application proposes to test a clinical outcome as its primary objective, it should be submitted to an FOA in the NIAMS Clinical Trial Suite. For more information about mechanistic studies, refer to NOT-AR-21-009.
Parent R21: NIH Exploratory/Developmental Research Grant Program (Clinical Trial Required) PA-20-194
Parent R01: NIH Research Project Grant (Clinical Trial Required) PA-20-183
Career Development
Parent K01: Mentored Research Scientist Development Award (Independent Clinical Trial Required) PA-20-176
Parent K23: Mentored Patient-Oriented Research Career Development Award (Independent Clinical Trial Required) PA-20-206
Parent K99/R00: NIH Pathway to Independence Award (Independent Clinical Trial Required) PA-20-187
Parent K24: Midcareer Investigator Award in Patient-Oriented Research (Independent Clinical Trial Required) PA-20-193
NOTE: Applicants who propose clinical trials submitted in response to other CT Required or CT Optional funding opportunity announcements not listed on this page will follow the guidelines and instructions in those announcements.
NIH Clinical Trial Programs and Resources
Investigators seeking support only for drug development and who do not have access to medicinal chemistry and drug development expertise are encouraged to consider other programs for those areas which are available through individual NIH Institutes.
Bridging Interventional Development Gaps (BrIDGs)
Previously known as the NIH Rapid Access to Interventional Development (NIH-RAID) Program, this program offers investigators access to IND-directed services on a competitive basis. Investigators who are seeking support for such studies are encouraged to apply there.
Therapeutics for Rare and Neglected Diseases (TRND)
This program is designed to support pre-clinical development of therapeutic candidates intended to treat rare or neglected disorders, with the goal of enabling an Investigational New Drug (IND) application. TRND stimulates drug discovery and development research collaborations among NIH and academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses. Investigators are encouraged to refer to NCATS TRND to determine if there are opportunities offered through this program that suits their needs.
This program is designed to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The network will focus on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the NCATS CTSA Program.