Clinical and translational biology research moves scientific findings from the laboratory to real-world practice, resulting in better human health.
Definitions of translational research courtesy of Harvard Catalyst and the Harvard Clinical and Translational Science Centre, both of which are Clinical and Translational Science Award (CTSA) member institutions. Please keep in mind that unique CTSI funding and professional development initiatives may have different or more stringent eligibility requirements.
T1 investigation
T1 research examines fundamental research results for clinical relevance and/or application. T1 research contributes to the understanding of human physiology and the possibility of intervention.
Among the approaches are:
- Preclinical and Animal Research
- First in Humans (FIH) (healthy volunteers) Human Physiology
- POC stands for Proof of Concept.
- Phase I Clinical Trials: For the first time, a novel biomedical intervention is tested in a small sample of individuals (e.g., 20-80) to verify effectiveness and evaluate safety (e.g., determining a safe dose range and identifying adverse effects).
T2 investigation
T2 research puts innovative strategies to the test in controlled contexts, laying the groundwork for clinical applications and evidence-based recommendations. T2 research provides information regarding the effectiveness of therapies in ideal circumstances.
Among the approaches are:
- Phase II Clinical Trials: Examines the effectiveness and safety of a biological or behavioural intervention in a larger number of participants (several hundred).
- Clinical Trials in Phase III: A large clinical trial (typically including several hundred human patients) to compare an experimental intervention to a standard or control intervention or to compare two or more established therapies. The term encompasses pharmaceutical, non-pharmacologic, and behavioural therapies used for illness prevention, prophylaxis, diagnosis, or treatment. There are also community trials and other population-based intervention studies mentioned.
T3 investigation
T3 research investigates methods of implementing suggestions or guidelines in general practise. T3 research elucidates how treatments function in real-world contexts.
Among the approaches are:
- Studies undertaken after the intervention has been commercialised are referred to as Phase IV clinical trials. These studies are intended to track the efficacy of the authorised intervention in the general population and to gather data on any adverse effects associated with extensive usage.
- Health Care Services Research
Dissemination
Communication
Implementation
- Clinical Results Research
T4 investigation
T4 research investigates variables and strategies that impact population health. T4 study eventually leads to better world health.
Among the approaches are:
- Population-level Outcome Research
- Social Health Determinants
