Translational Research Approach

Translation to Humans

With T1 translational research, findings from basic research are tested for clinical effect and/or applicability. T1 research yields knowledge about human physiology and the potential for intervention.

Example:

  • Preclinical and Animal Studies
  • Human Physiology (study must be related with a human disease)
  • First in Humans (FIH) (healthy volunteers)
  • Proof of Concept (POC)
  • Phase 1 Clinical Trials (dose and toxicology)
  • First time evaluation of a biomarkers (antibodies, none treatment involved)

Translation to Patients

With T2 translational research, investigators test new interventions under controlled environments to form the basis for clinical application and evidence-based guidelines. T2 research yields knowledge about the efficacy of the interventions in optimal settings.

Example:

  • Phase 2 Clinical Trials- biomedical or behavioral interventions with more than 100s patients.
  • Phase 3 Clinical Trials- compare and evaluate two interventions (news vs. controls) including pharmacotherapy trials and behavioral interventions.
  • Behavioral intervention studies with a small patient’s sample.
  • New intervention

Translation to Practice

With T3 translational research, investigators explore ways of applying recommendations or guidelines in general practice. T3 research yields knowledge about how interventions work in real-world settings.

Example:

  • Phase 4 Clinical Trials- side effect studies “post marketing surveillance trials”
  • Health Services Research (Dissemination, Communication, and Implementation)
  • Community Research
  • Clinical Outcomes Research
  • Know effective clinical intervention
  • Focus on clinical practices

Translation to Population Health

With T4 translational research, investigators study factors and interventions that influence the health of populations. T4 research ultimately results in improved global health.

Example:

  • Population-level Outcome Studies
  • Outcome Studies of Mass Screenings
  • Social Determinants of Health

Clinical and translational research is characterized by a spectrum of activities where critical insights are passed between research modalities so that biomedical discoveries can lead to tangible improvements in human health. Explore the video and interactive diagram to learn more.

The translational science spectrum represents each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public. The spectrum is not linear or unidirectional; each stage builds upon and informs the others. At all stages of the spectrum, NCATS develops new approaches, demonstrates their usefulness and disseminates the findings. Patient involvement is a critical feature of all stages in translation.