神経疾患の医薬品開発に期待すること―承認審査の立場から

抄録

Clinical trials are planned and conducted to evaluate the efficacy and safety of pharmaceuticals. It is important to refer to guidelines for clinical trial or clinical practice, as well as information of previous clinical trials when considering the target population and efficacy endpoints of clinical trials. The goals of treatment and the concept of efficacy evaluation described in clinical guidelines are useful to conduct clinical trials that are in line with clinical practice. The guidelines and diagnostic criteria developed by academic societies provide important information for the planning of clinical trials in terms of target population. It is expected that the development of new drugs will be promoted through the development and revision of clinical practice guidelines by academic societies.