According to the Medical Care Act, human research is a method for evaluating the effects of new drugs, medical devices, medical technologies, or generic drugs on the human body. Since many treatments, medications, medical devices, and vaccines do not always produce the same results in humans as they do in animal tests, it is essential to gather relevant information—such as effectiveness and potential adverse reactions—before widespread application. Thus, human research is necessary to collect this information, allowing us to determine the most suitable treatment methods or dosages for patients. The results of these studies can then be translated into valuable medical knowledge that enhances the health, longevity, and well-being of humanity. Therefore, human research is an indispensable part of medical advancement.
The process of developing new drugs requires prior approval for human clinical trials (Investigational New Drug, IND) before proceeding to the various phases of clinical trials (Phase I, II, III, IV). If the drug's efficacy is confirmed during Phase III clinical trials, a New Drug Application (NDA) can be submitted for marketing approval.
