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Genesis of Changes to Legislation and Guidelines that Regulate Clinical Trials.

The genesis of changes to legislation and guidelines that regulate the development and licensing of medicines is complex and involves discussion and negotiation among a large number of people with different aims, interests and starting points. Those proposing a change to the way clinical trials are conducted need therefore to promote their proposal within the groups established for bringing forward changes to the guidance and legislation by participation in or responding to consultations. This paper reviews established European Union, United Kingdom and International procedures that would have to be used to introduce changes to clinical trials guidelines and legislation.