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  • Title: From translational research to a large randomized clinical trial: a long and streanuous way from bench to bedside.
    Author: Sakamoto J, Morita S.
    Journal: Nagoya J Med Sci; 2007 Jan; 69(1-2):9-16. PubMed ID: 17378175.
    Abstract:
    Several complicated steps are should be necessary to bring bioscientific products successfully to market. Products generated on the bench first have to be called screened for safety in a Phase I clinical trial. This step is called translational research, indicating that the material must be proven safe not only for experimental animals, but also for human subjects. Once the Phase I study is completed, Phase II determines the safety of the bioscientific products on humans, establishing both its maximum tolerated dose and recommended dose. In a Phase II study, the material should be tested for its efficacy against certain diseases. Once it is found to be effective, a comparison between the current actual standard therapy and the new therapy using the newly developed material will be implemented in a large or against scale randomized trial, after which a final decision must be made for its approval as a new drug. The authors have illustrated the steps of: a Phase I translational research by showing the data of a monoclonal antibody A33; a Phase II trial with several combination chemotherapies of chemotherapeutic agents; a Phase III clinical trial through a comparison of antihypertension agents to show the evolutionary process from translational research to a large randomized trial based on their own experience.
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