The National Center for Advancing Translational Sciences (NCATS) strives to develop innovations in order to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates. NCATS is interested in supporting clinical trials that aim to improve this translational process. Some examples of research that could be supported through this FOA include but are not limited to

• Testing of innovative technologies that demonstrably increase the efficiency and effectiveness of intervention testing.
• Validation of innovative outcome measures or biomarkers that could increase the efficiency of clinical trials.
• Testing innovative clinical trial designs, such as adaptive designs or other approaches, that would enhance clinical trials with small sample sizes.
• Evaluation of novel endpoints that demonstrate applicability across multiple disease states.
• Testing of innovative methodologies to speed development of therapeutics for those with rare diseases.

1. Applications proposing to conduct non-pharmacological intervention research must define the stage of intervention development proposed as defined by the NIH Stage Model.
2. Applications should adhere to NIA Guidance on Clinical Trials.

The mission of the National Institute on Drug Abuse (NIDA) is to advance science on the causes and consequences of substance use and substance use disorders (SUD) and to apply that knowledge to improve individual and public health. In this regard, NIDA addresses the most fundamental and essential questions about substance use and SUD — from detecting and responding to emerging trends and understanding how substances work in the brain and body, to developing and testing new approaches to treatment and prevention. NIDA is interested in supporting mechanistic clinical trials* and Basic Experimental Studies with Humans (BESH) that aim to aid these processes through this FOA.

Some examples of research include but are not limited to:

• Neuroimaging and behavioral studies investigating specific SUD-related neural circuits and/or cognitive constructs
• Modulation of SUD-related circuits using pharmacological manipulation or non-invasive brain stimulation to investigate neural mechanisms underlying cognition, behavior, and clinical outcomes relevant to SUD
• Testing of environmental, behavioral, or pharmacological manipulations as potential treatment or prevention targets for SUD, with emphasis on mechanisms of action
• Leveraging AI/ML for integrating data; Natural Language Processing (NLP) for analysis and of data from disparate sources (medical records, policies, wearable devices, etc.)
• AI-based image analysis
• AI to monitor behavior
• Multi-disciplinary collaborations

*A mechanistic clinical trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, biomarkers for a disease or response to treatment, or the mechanism of action of an intervention. It is not designed to test the safety or demonstrate the efficacy/effectiveness of an intervention.

• The NIDCR policy that applies to grants involving human subject research
• Toolkit for interventional studies