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Translational Research Definitions

The CHEST Foundation’s research and distinguished scholar grants are geared toward higher-level translational research projects. According to the National Institutes of Health, translational research is defined as:

  1. 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
  2. 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.

T-Level Definitions

Basic Biomedical Science or Discovery1

  • Goal is 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 molecules1,6
  • 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"
    • The environment in which humans exist
        • Often the identification, creation, engineering, or analysis of environmental elements
  • Does not include:
    • Interventions with human subjects or relationships that may alter the human condition or its environment
  • 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
  • T0 Examples of the human environment
    • “Bench science” or “Raw science”
    • Preclinical (Animal) models – “proof of Mechanism”
    • Chemicals, molecules, devices, structures
  • May or may not consider a particular disease process

Translation to Humans1–Clinical Insights

  • Goal is to identify and analyze the effects of an intervention or relationship on the human condition or environment
    • The effect of an intervention
      • Ex. “fMRI in Adults with Alzheimer's taking Aricept”
    • The effect of a relationship
      • Ex. “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

Translation to Patients – Practice Implications

  • Goal is to identify and analyze the optimal effects of an intervention or relationship on the human condition or environment
    • The optimal effect of an intervention1
      • Ex. “Aricept Dose Based on fMRI in Adults with Alzheimer’s”
    • The optimal effect of a relationship
      • “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 Practices1,2

Translation to Practice1,3

  • Goal is to incorporate into practice the optimal intervention or relationship
  • Phase 4 clinical trials – focus on post-marketing analysis
    • Clinical outcomes
    • Comparative effectiveness
  • Implementation of Evidence-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

Translation to Communities

  • Goal is to provide communities with the optimal intervention or relationship
  • Studies focusing on disease prevention through life-style 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 studies.4,6
  • Results in true benefit to society1

Translation to Global Communities

  • Goal is 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 health1,5


References

  1. 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.
  2. Harvard CTSA: http://catalyst.harvard.edu/pathfinder/
  3. 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.
  4. UT Southwestern Medical Center: Translational Research (http://www.utsouthwestner.edu.research.translational-medicine/about/translational/index.html)
  5. 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.
  6. ICTR–University of Madison: Research Continuum Classification Fields

Page copyrighted 2013, Clinical & Translational Science Institute of Southeast Wisconsin

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