ABSTRACT

With the strong emphasis on quality-of-life evaluation and medical outcome research in the current drug development environment, it is surprising that the effort to conduct a meaningful benefit and risk assessment to support the regulatory approval of a new drug stays at the minimum level. By meaningful benefit and risk assessment, 1 mean an assessment whereby each patient is considered as a whole with their safety and efficacy experience in a trial combined to obtain an overall outcome measure. The closest measure to achieve this goal is the YUYOSEI1 instrument commonly used in Japanese clinical trials. YUYOSEI is a global assessment given by the treating physician to reflect, in the physician's opinion, an individual's overall response to a treatment. By its very definition, YUYOSEI has objective and subjective components, since the sense of well-being of a patient can be quite subjective. For this reason, YUYOSEI has recently come under attack for not being objective enough and there has been some discussion of discontinuing its use. In the author's opinion, throwing away this global measurement because of its subjective component is foolish, because subjective evaluation exists in many aspects of clinical trials. One example is the reporting of clinical symptoms by individuals in a trial. Therefore, instead of advocating the abolition ofYUYOSEI, I want to argue the need to make this seemingly subjective measure as objective as possible when it is used for decision-making purposes.