What is Clinical & Translational Research?

Definitions to common terms used throughout our organization

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.

Source: RFA-RM-07-007: Institutional Clinical and Translational Science Award (U54) Mar2007

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

Focuses on understanding biological, social and behavioral mechanisms that underlie health or disease, defining mechanisms, targets, or lead molecules16
Studies mechanisms or derive modifications of cells, proteins, and DNA that are present in human disease processes1

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

Proof of Concept1
Healthy subjects or select population of patients
Small sample size
Tests for safety2

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

[T3 Research] TRANSLATION TO PRACTICE1 3

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)1 2
Includes development of guidelines, meta-analyses, and systematic reviews involving interventions6
Explores ways of applying recommendations or guidelines in general clinical practice or policies1 2

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

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