The Significance of Adaptive Design in R&D in Japan

In the past decade, the number of drug and biological product submissions to the United States Food and Drug Administration has been slowly declining, while biomedical research spending has increased. A similar situation can also be seen in Japan: the number of domestic clinical trials is diminishing, and the cost of conducting a trial is rising. To prevent further decreases in the number of clinical trials, there is a need for an innovative strategy such as an adaptive design in research and development. Integrative celerity research aims to combine critical path and translational research, and seek update and participation in global clinical research. Participation in global studies through an adaptive design raises statistical concerns, which can be dealt with by adapting bridging studies. As a result of the restricted number of patients before approval in the adaptive design, safety issues must be guaranteed. Thus, establishing an effective and strong safety network between medical facilities is crucial. Japan's mission is to develop better drugs more efficiently and to investigate new drug methodologies for participation in global/Asian studies. Team work between clinical trial specialists, computer scientists, medical doctors, and statisticians is important for the success of both adaptive design and construction of a safety network between medical facilities in Japanese research and development.