The Exploratory Clinical Trial Grant Program fosters the development and implementation of interventional exploratory clinical trials aimed at providing clinically meaningful improvements in symptoms, function or disease course for patients with rheumatic, musculoskeletal or skin diseases. The trials must address research questions related to the mission and goals of the NIAMS and may evaluate drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies.
Purpose
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 diseases.
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 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.
The rationale for the proposed study should be supported by strong preclinical data. Preliminary data specifically related to clinical effect of the proposed intervention in the targeted condition are not required for R61 applications; however, they may be included if available.
Research Area Examples
- Conducting early-stage safety/tolerability/dose/efficacy trials with drugs, biologics, devices, behavioral interventions, and/or physical therapy for treatment of arthritis, musculoskeletal or skin disease.
- 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.
Drug Development
Basic laboratory research or studies of laboratory animals are not appropriate for this funding opportunity. PDs/PIs who are seeking support only for drug development and 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. The Bridging Interventional Development Gaps (BrIDGs) program, is an NCATS initiative that provides expertise and resources to facilitate pre-clinical drug development through research collaborations for both common and rare diseases. Investigators seeking to complete pre-clinical therapy development are encouraged to submit a request to this program.