Good Clinical Practices: Principles and Application of the European Community Note for Guidance

Abstract

The first document to address ethical issues associated with good clinical practices (GCP) can be traced to the Nuremberg Code of 1947. Since then, the Declaration of Helsinki and numerous national guidelines have aimed to provide direction to clinical researchers to ensure ethical behavior. Of particular interest to the European-based pharmaceutical industry is the European Community (EC) Note for Guidance. This document provides direction on informed consent, ethics committees, and study conduct by outlining the responsibilities of the sponsor, monitor, and investigator. Unfortunately, the implementation of GCP can have negative effects which may appear to oppose basic principles. The bureaucratization of the research process and the consequent demand for increased resources can impede research. New electronic systems for data transmission and the introduction of coordinators, monitors, and auditors to a study require particular attention to safeguard the patients' confidentiality. By adopting higher ideals and greater respect for the integrity of data, however, GCP will enhance the quality of research and permit greater international consistency. The establishment and acceptance of a single standard of conduct should expedite global drug development and facilitate the introduction of new agents to world markets.