Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 19

The advent of the GCP Guideline and its adoption as a global reference for the conduct of human biomedical clinical trials is a story that emerges from a number of business and regulatory objectives that came together in the early 1990s. The chronology of regulatory legislation, historical incidents, and ethical policy development listed earlier formed the backdrop for the success of the ICH organization. It is noteworthy that GCP stood out as a key early guideline development project. Protection of trial subjects and the assurance that data can be trusted were central themes for regulators and the pharmaceutical drug manufacturers were keen to find the protocols which would have a universal appeal. The story of the ICH in general and the development of GCP in particular is one where everyone was a winner.