Protection of Subjects Participating in Clinical Trials

摘要

Clinical trials constitute one of the final stages along the testing continuum that is so needed for the introduction of new products, methods, and ground-breaking technologies. Currently, most economies have recognized the importance clinical trials play as part of the entire value chain from idea to product. While most jurisdictions have developed systems of safeguards for the protection of human subjects involved in clinical trials, there are huge disconnects among jurisdictions, institutions and investigators. This article provides some generally accepted international standards and guidelines in relation to subject protection as it pertains to recruitment, confidentiality, monitoring, data storage and data transfer. The need for all trial protocols to be reviewed by a qualified and registered ethics committee, as well as that all legal requirements are met to ensure patient protection, is also highlighted. Since governments and industry see clinical trials as a critical and necessary step in the product development process, there is a need for more translational research, which will increase the demand for more participation in clinical trials. This article will therefore, also address the importance of patient protection if we are to meet these requirements.