What is Clinical Research?
The NIH definition of clinical research has three parts:
- 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. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
- Epidemiologic and behavioral studies
- Outcomes research and health services research
Source: Glossary of NIH Terms
What is Translational Research?
Translational research is defined by the National Institutes of Health as:
- The process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans (as well as the process of applying bedside observations to inform bench to discoveries); and
- Research aimed at enhancing the adoption of best practices in the community. In more everyday terms you might think of translational research as moving the research process through phases from bench to animal to human to guidelines development to public health and ultimately to population outcomes and global health.
CTSI Translational Continuum – T-Level Definitions
T0
[T0 (T Zero) Research] BASIC BIOMEDICAL SCIENCE OR DISCOVERY1
GOAL: To understand the human condition and environment as it exists
- The condition of humans, often a statement or declaration identifying a human status – e.g. “fMRI in Adults with Alzheimer’s” or “fMRI in Adults with Alzheimer’s and Depression”
- T0 Examples of the human condition
- Bio-markers, cells, proteins, DNA, tissues, chemistries
- Physical assessments – radiology, laboratory, biopsy
- Registries, surveys, data banks,
- Natural histories, observations, patterns, classifications, correlations
- Gene mappings, banking, sequencing
- The environment in which humans exist, often the identification, creation, engineering, or analysis of environmental elements
- T0 Examples of the human environment
- “Bench science” or “Raw science”
- Preclinical (Animal) models – “Proof of Mechanism”
- Chemicals, molecules, devices, structures
- Does not include interventions with human subjects or relationships that may alter the human condition or its environment
- May or may not consider a particular disease process
T1
[T1 Research] TRANSLATION TO HUMANS1 – CLINICAL INSIGHTS
GOAL: To identify and analyze the effects of an intervention or relationship on the human condition or environment
- The effect of an intervention
Example: “fMRI in Adults with Alzheimer’s taking Aricept” - The effect of a relationship
Example: “fMRI in Adults with Alzheimer’s at Risk for Depression” - Phase I clinical trials – focus on safety and pharmacokinetics
- Produces novel methods of diagnosis, treatment, and prevention in humans
- Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.)2
- Terms to keep in mind: relationship, patients, humans
T2
[T2 Research] TRANSLATION TO PATIENTS – PRACTICE IMPLICATIONS
GOAL: To identify and analyze the optimal effects of an intervention or relationship on the human condition or environment
- The optimal effect of an intervention1
Example: “Aricept Dose Based on fMRI in Adults with Alzheimer’s” - The optimal effect of a relationship
Example: “Depression Identification using fMRI in Adults with Alzheimer’s” - Phase 2 clinical trials – focus on safety and efficacy1 (dose-response)
- Select population of patients
- Relatively large sample size
- Phase 3 clinical trials – focus on safety and efficacy
- Select population of patients
- Special groups of patients (ex. renal failure)
- Large sample size – Controlled and uncontrolled trials
- Long-term – observational
- Development of Evidence-based guidelines, Policies and Best Practices12
T3
GOAL: To incorporate into practice the optimal intervention or relationship
- Phase 4 clinical trials – focus on post-marketing analysis
- Clinical outcomes
- Comparative effectiveness
- Implementation of Evidenced-based guidelines, Policies, and Best Practices2
- Delivery of Care2
- Access
- Timeliness
- Education and Information
- Includes health services research & community-based participatory research (dissemination, communication, implementation research)12
- Includes development of guidelines, meta-analyses, and systematic reviews involving interventions6
- Explores ways of applying recommendations or guidelines in general clinical practice or policies12
T4
[T4 Research] TRANSLATION TO COMMUNITIES
GOAL: To provide communities with the optimal intervention or relationship
- Studies focus on disease prevention through lifestyle and behavioral modifications1
- Documents “real-world” health outcomes of population health practices associated with improved disease prevention and reduced medical costs1
- Documents wider dissemination/implementation of improved practices/interventions (taking to scale) Includes population-level outcomes research; population monitoring of morbidity, mortality, benefits and risk studies46
- Results in true benefit to society1
T5
[T5 Research] TRANSLATION TO GLOBAL COMMUNITIES
GOAL: To provide global communities with the optimal intervention or relationship
- Documents impacts of policy and/or environmental change1
- Ultimately results in improved global health by reforming social structures that impede or restrict healthcare delivery1
- Research involves investigators with knowledge that extends beyond the lab and clinic (political and social scientists, economists, anthropologists, and population biologists)
- Studies in the context of social determinants of health15
References Cited
- Waldman, Scott A. and Andre Terzick. Clinical and Translational Science: From Bench-Bedside to Global Village. Clinical and Translational Science. 2010 Oct;3(5):254-7.
- Harvard CTSA, Harvard Catalyst Pathfinder
- Khoury MJ, Gwinn M, Yoon PW, Dowling N, Moore CA, Bradley L. The Continuum of Translational Research in Genomic Medicine: How can We Accelerate the Appropriate Integration of Human Genome Discoveries into Health Care and Disease Prevention. Genetic Medicine. 2007 Oct; 9(10):665-74.
- UT Southwestern Medical Center: Translational Research
- Marmot M., Sharon Friel, ruth Bell, Tanja A J Houweling, Sebastian Talyor. Closing the health gap in a generation: health equity through action on the social determinants of health. 2008. Lancet 372: 1661–69.
- ICTR – University of Madison: Research Continuum Classification Fields
NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.
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