Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Exploratory Clinical Trials Grants Program in the mission areas of NIAMS. The goal of the NIAMS clinical trial program is to support research leading to the prevention or reduction of symptoms and improve outcomes and function in patients with rheumatic, musculoskeletal, or skin conditions or diseases. The purpose of the Exploratory Clinical Trials Grants Program is to foster clinical trials that will lead to clinically meaningful improvements in prevention, diagnosis, or treatment of these conditions or diseases.

This Exploratory Clinical Trials Grants Program is designed to facilitate the execution of short-term, interventional studies. The Program is intended to support a range of exploratory studies, from proof-of-concept/first in human to Phase I and Phase II clinical trials. Such studies must meet the NIH definition of a clinical trial and be feasible within the time and budget constraints of this 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.

Examples of research areas of interest include, but are not limited to:

• Conducting early-stage clinical trials, such as but not limited to; first in human, dose-finding or escalation/tolerability/safety/efficacy studies with drugs, biologics, devices, behavioral interventions, and/or physical therapy for treatment of arthritis, musculoskeletal, or skin conditions or diseases.
• Clinical trials to provide data required to support a future, more robust clinical trial whose aim is to help establish the safety and efficacy or effectiveness of an intervention.
• Clinical trials in rare diseases where the number of potential study participants is limited.
• Clinical trials to determine the predictive value of a potential biomarker.