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.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...