16th DIA Japan Annual Meeting 2019

Since long ago, clinical trials have been conducted using a placebo arm in drug development. The meaning of setting the placebo arm as the theory of clinical trial design is well established and understood among those involved in drug development. On the other hand, it is also a fact that the clinical trial sites or patients have a sense that “it is difficult to conduct a trial with a placebo arm”, “does not want to receive a placebo”, which makes difficult to conduct the clinical trials. In this session, we asked the question, “Is the placebo arm really necessary?”, Referring to the state of the anticancer drug, and receiving opinions from doctors, patients, industries, and regulators in Japan and overseas viewpoints, discuss the possibility of clinical development without putting placebo arm.