The Good Clinical Practice guideline: a bronze standard for clinical research.

Discusses the deficiencies of the Good Clinical Practice (GCP) guideline developed by the International Conference on Harmonisation (ICH) and proposes some practical solutions. Criticism of the manner in which the GCP was developed; How the GCP has not been updated since 1996 and how it uses wording from the United States Food and Drug Administration regulations and guidelines; Description of solutions to described problems.