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Translational Research Process

Translational research is often described as having two main areas of translation, referred to as T1 and T2: 

  • T1 involves the translation of basic science discoveries from the laboratory to the clinic (bench to bedside), including completion of preclinical studies and development of human clinical trial protocols. 
  • T2 involves the translation of new therapies/practices resulting from clinical research studies to clinical practice (bedside to community), including adoption of new therapies/practices in clinics in the community.

 

Translational Research Flow

 

Translational Research Flow 

 

  

The Process from Basic Science Drug Discovery to Clinical Research 

Early Stage
Preclinical
Development

  

 

 

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 image only In this stage, drug discovery is protected for future development, preclinical efficacy is established, and the Investigational New Drug (IND) process is initiated.

Late Stage
Preclinical
Development

 

 

 

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  In this stage, clinical grade drug is produced,  toxicity studies required for IND are completed,  clinical protocol is developed and IND application is submitted.

Go/Hold
Decision

FDA In this stage, the IND application is reviewed by the FDA, a go or hold decision is rendered.

View Drug Discovery: Preclinical Research Development (2-10 years) Detailed Flow for a map describing drug development from concept to implementation.