Research

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What Is Transitional Research

Translational Research is defined as the translation of observations made in the research laboratories and clinical services at CHB and elsewhere into clinical studies involving humans, or the use of clinical observations to define basic research hypotheses or studies. Innovative use of clinical material in basic laboratories is considered translational research. A research study qualifies as translational if it:

  • Uses new approaches or discoveries to address clinical problems.

  • Develops new experimental or diagnostic reagents and procedures to diagnose and treat childhood illnesses and condition.

  • Develops new models of human diseases and uses them to inform clinical issues involving children.

  • Adapts approaches already in place in other disciplines to address pediatric diseases.

Non-Clinical Translational Research: Non-clinical translational research is laboratory research that leads to a plan or design for new or improved elements of child health care, whether intended for internal use or use by others outside of CHB. It includes the conceptual formulation, design, pre-clinical, and post-clinical testing of a range of diagnostic and therapeutic products and procedures, as well as health services processes. The term “non-clinical” is preferred to “pre-clinical”, because non-clinical also encompasses laboratory testing done after the introduction and testing of an agent, device, or procedure in humans.

Clinical Translational Research: Clinical translational research is confirmation in human clinical testing or observation that the products, procedures and health services processes created to improve child health deliver the expected benefits without unacceptable side effects. This category includes feasibility and safety pilot studies and traditional Phase I clinical trials, with assessments of safety and clinical effectiveness. In addition, clinical translational research encompasses the use of clinical observations or reagents to drive basic laboratory studies. Phase II trials will rarely be considered translational research. 

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For more information on translational research or to see if your project qualifies as "translational," contact trp@childrens.harvard.edu.

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