ViewpointThe Good Clinical Practice guideline: a bronze standard for clinical research
Section snippets
Background
Documentation of compliance with GCP is required for all submissions approved by regulatory agencies in the European Union, the USA, Japan, and Canada. A series of numbered ICH “efficacy” guidelines have been developed on various topics (E1 through E12A). This voluminous material (now totalling 367 pages) can be confusing (eg, when downloaded from different web sites, some identical documents have different titles and dates). The document on which we will mainly focus is “Good Clinical
Deficiencies of GCP
The term “Good Clinical Practice” is a misnomer (table). This unofficial jargon refers to US Food and Drug Administration regulations and guidelines organised within the US Code of Federal Regulations.2 Unfortunately, other organisations, such as the UK Medical Research Council, have adopted the GCP misnomer. “Good Clinical Practice” here does not relate to clinical practice, but, rather, to the conduct of clinical research.
Four general approaches to guideline development exist: informal
Solutions
One option would be to drop the GCP requirement for research that is not destined for a regulatory agency. Much of the documentation required by ICH-E6 has no relevance to research validity or reliability. Given its burdensome requirements, insistence on GCP for non-regulatory research seems poorly advised.
A second solution would be to revise GCP. Although ICH-E6 contains much useful material, its development process was neither inclusive nor evidence-based.3 Moreover, ICH-E6 is obsolete and
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