[Challenges and Prospects of a Specific Clinical Study].

ABSTRACT

The term"clinical trials"as used in the Clinical Trials Act refers to research aimed at determining the efficacy or safety of pharmaceuticals by administering them to humans. The term"specified clinical trials"as defined in this Act encompasses clinical trials that meet either of the following criteria(i)Clinical trials funded or supported by a manufacturer with marketing approval for the pharmaceuticals or(ii)Clinical trials involving unapproved or off-label pharmaceuticals. Such research must comply with the standards established by the Clinical Research Act. The Clinical Research Subcommittee is deliberating strategies to bolster the conduct of clinical research in alignment with international standards. Discussions encompass establishing sponsors for multi-institutional collaborative research, utilizing collected data for drug application submissions, re- evaluating the legal parameters of observational studies, defining the extent of off-label use research, assessing the applicability of laws to medical devices, digitizing and simplifying notification and amendment processes, and introducing various modifications and strategies to uphold research quality. The objective is to refine the clinical research framework and enhance access to pertinent information.