title: From translational research to a large randomized clinical trial: a long and streanuous way from bench to bedside.
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.
authors: Young Leaders' Program, Nagoya University Graduate School of Medicine, Japan. sakamjun@med.nagoya-u.ac.jp
authors: Junichi
authors: J
authors: Sakamoto
authors: Satoshi
authors: S
authors: Morita
mesh_terms: D035843:Biomedical Research; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000639:trends; D018581:Technology Transfer