Learn about the ethical standards and guidelines for clinical trials in this lecture from Kyoto University Graduate School of Medicine's course on Biostatistics for Clinical Researchers. Explore why clinical trials are necessary, who qualifies as subjects, and the historical development of human experimentation regulations. Examine the essential conditions for conducting clinical trials and tackle challenging ethical scenarios, particularly when scientific validity raises ethical concerns. Delve into the complexities of designing clinical trials for dramatically effective new drugs, understanding various trial designs and their rationale. Associate Professor Keiko Sato from the Hospital's Medical Safety Management Department guides through these critical aspects of clinical research methodology and ethics.