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 (R61)

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 Notice of Funding Opportunity (NOFO). 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 Consultation

Investigators should contact the appropriate NIAMS Program Director prior to submitting applications for a NIAMS Exploratory Clinical Trial (R21) grant or a NIAMS Clinical Observational (R01) grant. 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.

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 Opportunities

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 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

Additional Review Criteria for Career Development Award Applications Involving Clinical Trials NOT-OD-18-109

NOTE: Applicants who propose clinical trials submitted in response to other CT Required or CT Optional funding opportunities 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.

Trial Innovation Network

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.

Last Updated: