Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 78

Experiments with and outright distribution and sale of products for the diagnosis, treatment, cure, or prevention of disease have resulted in a range of harmful effects to the safety and well‐being of humans. Individual countries established regulatory requirements for clinical research in the development of a product to prevent such harmful effects. However, due to the cost of redundancies in resources, time, and additional exposure of an unapproved product to human subjects, a single guideline was developed with consideration of the current good clinical practices (GCPs) of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). The objective of ICH E6 (R2) Guideline for GCP is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. (ICH E6(R2) Introduction; Section on Good Clinical Practice History; Section on Drug Development in the Regulatory Environment).

The Guideline presents a set of international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects (ICH E6(R2) Introduction). The goal for anyone involved in the conception, planning, and execution of a trial is to conform with these standards that provide public assurance that the rights, safety, and well‐being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The Guideline starts with definitions and principles as the foundation for the responsibilities and operational standards that are presented in the Guideline.

In this chapter, we will define GCP and present a practical interpretation of the GCP principles.