ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
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The International Council for Harmonisation has proposed modernizing its July 1997 guideline on general considerations for clinical trials. The proposal also kick-starts the GCP renovation project, which aims to remove inconsistencies in how randomized control trials are conducted.
The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.
The European Medicines Agency is seeking feedback on a modernized version of a 19-year-old guideline on good clinical practice (GCP) that has been updated to factor in improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting1,2.