SW CACTI Pilot Resources & FAQ

Translational Science Information: 

 Translational Research vs Translational Science PDF

Translational Research: Theendeavor to traverse a particular step of the translational process for a particular target or disease. 

Translational Science: The field of investigation focused on advancing the scientific and operational principles underlying each step of the translational process. 

NIH Definition of Clinical Research 

Research with human subjects that is: 

Patient-oriented research 

Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. 

It includes: 

Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. 

Additional Clinical Research Categories 

• Epidemiological and behavioral studies  
• Outcomes research and health services research  

NIH Definition of Clinical Trial 

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. 

NOTE: Clinical Trials will NOT be funded. 

NIH Definition of Human Subjects Research 

According to Federal Uniform Guidance 45 CFR 46 Link to Non-U.S. Government Site - Click for Disclaimer, a human subject is: 

"a living individual about whom an investigator (whether professional or student) conducting research: 

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or  
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." 

NCATS Priorities in Translational Science 

*Items marked with an asterisk are considered particularly important translational bottlenecks

• Understanding of translation
• Translational Science
• Target qualification*
• De-risking undruggable
• Targets/untreatable diseases*
• Predictive efficacy and predictive toxicology
• New therapeutic modaities; repurposing*
• Biomarker qualification
• Data interoperability and transparency*
• Registries and natural history studies*
• Clinical diagnostic and outcome criteria
• Single/harmonized IRBs
• Electronic Health Records for research
• Shortening time of intervention adoption*
• Access and adherence
• Pharmacoepidemiologic studies and comparative effectiveness trials*
• Integration of project management
• Incentives/credit for team science
• Incentives/credit for health improvements
• Education/Training (Scientific and cultural)
• Collaborative structures, agreements, IP management
• Parent/community engagement 

Key References: 

• Opportunities and Challenges in Translational Science - Article
• Translational Science Principles - NIH Website
• SW CACTI Translational Science Panel Video