Table 1 Full definitions for each of the phases along the translational research spectrum
T0 | Basic biomedical research: identification of opportunities and approaches to health problems |
Includes preclinical and animal studies | |
May or may not consider a particular disease process | |
May include human subjects, but does not include interventions with human subjects | |
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, biomarkers, targets for therapeutic development; drug discovery (lead molecule screening, optimization, formulation); prototyping; physical assessments (radiology, laboratory, biopsy) | |
Can include non-interventional, correlational epidemiologic studies using existing large data sets | |
Studies mechanisms or derive modifications of cells, proteins, and DNA present in human disease processes | |
Identifies functional significance and mechanisms of genomic polymorphisms identified by human genome-wide association studies | |
T1 | Translation to humans: seeks to move fundamental discovery into health application; provide clinical insights |
Involves proof of concept studies | |
Includes Phase 1 clinical trials | |
Healthy subjects or select population of patients | |
Small sample size | |
Tests for safety | |
Focuses on new methods of diagnosis, treatment, and prevention | |
Takes place in highly controlled research settings | |
T2 | Translation to patients: health application to implications for evidence-based practice guidelines |
Involves controlled clinical research studies which may lead to the basis for clinical application and evidence-based guidelines | |
Yields knowledge about the efficacy of interventions in highly-controlled/protocol-driven settings | |
Goal is to identify and analyze the optimal effects of an intervention on the human condition or environment | |
Phase 2 clinical trials—focus on safety and efficacy (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) | |
T3 | Translation to practice: practice guidelines to health practices |
Includes comparative effectiveness, pragmatic clinical trials, community based participatory research, dissemination and implementation research, and clinical outcomes research, post-marketing analysis (Phase 4) | |
Health services research, including reasons for gaps in care and delivery of recommended and timely care to the right patient | |
Meta-analyses, and systematic reviews involving interventions | |
Development and implementation of evidenced-based guidelines, policies, and best practices | |
T4 | Translation to communities: health practice to population health impact, providing communities with the optimal intervention |
Includes population-level outcomes research: population monitoring of morbidity, mortality, benefits, and risks | |
Focuses on wider dissemination/implementation of improved practices/interventions (taking to scale) | |
Focuses on impacts of policy and/or environmental change | |
Studies focusing on disease prevention through lifestyle and behavioral modifications | |
Documents “real-world” health outcomes of population health practices associated with improved disease prevention and reduced medical costs | |
Results in true benefit to society |