[Status quo and problems in phase III trials: view of a trialist]

The quality of clinical trials in Japan has been improving through clear protocol preparation, improvements in methodology, coordinating systems, and so forth. In order to further improvement, the following are discussed: 1) dilemmas regarding adherence of treatment determined by protocol, 2) hospital policy and physician's discretion, 3) systems to support randomized controlled trials in hospital, and 4) systems to help obtain informed consent from subjects.