Translational Research 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 molecules^1,6
• 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 Practices^1,2

Translation to Practice^1,3

• 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 policies^1,2

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 health^1,5