From translational research to a large randomized clinical trial: a long and streanuous way from bench to bedside.
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.
Sakamoto
Junichi
J
Young Leaders' Program, Nagoya University Graduate School of Medicine, Japan. sakamjun@med.nagoya-u.ac.jp
Morita
Satoshi
S
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