@article{oai:nagoya.repo.nii.ac.jp:00005857,
 author = {Sakamoto, Junichi and Morita, Satoshi},
 issue = {1-2},
 journal = {Nagoya Journal of Medical Science},
 month = {Jan},
 note = {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.},
 pages = {9--16},
 title = {From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside},
 volume = {69},
 year = {2007}
}