Good clinical practices: past, present, and future.

Abstract

Clinical quality assurance has its roots in the evolution of the GCPs. Historically, the fundamental elements of GCPs provided a springboard to develop and refine a paradigm of standard measurements to assure the integrity and quality of research. The research community spontaneously responded by voluntarily establishing quality assurance units and implementing auditing functions to ensure the highest standards in an industry that encompasses science, medicine, and ethics. Although clinical quality assurance is still unregulated in the United States, the performance of good clinical practices has become an integral part of the clinical research process and has impacted the research community on worldwide basis. The establishment of the EC guidelines, the WHO guidelines, and the International Conference on Harmonization are testaments to the increasing emphasis on the future of GCP-related activities.