ICH shares "work-in-progress" update to GCP guidance

Regulatory NewsRegulatory News | 19 April 2021 |  By 

The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.
“The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials,” noted ICH.
In an explanatory note prefacing the draft updates, ICH explained that the updates to the good clinical practice (GCP) guidelines are designed to align with the revised guideline on general considerations for clinical studies, ICH E8(R1). The latter guideline “includes a framework for designing quality into clinical trials, stakeholder engagement, trial design, proportionate trial management and focus on factors critical to the quality of trials,” said ICH in the forward to the draft guidance.
The working group’s vision for the revised ICH GCP guideline, when it is complete, will include a document laying out overarching principles, an annex addressing interventional clinical trials and an additional annex addressing any considerations needed for “non-traditional” interventional clinical trials.
The draft of the guideline’s overarching principles, setting forth 12 broad considerations, is currently available for viewing. The principles range from an admonition to abide by the ethical principles of the Declaration of Helsinki, to recommendations to base trials on “robust and current scientific knowledge and approaches” with clear protocols, to recommendations to run trials that generate reliable results in accordance with applicable good manufacturing practice. Many of the 12 key principles have several sub-heads giving more detailed advice for trialists.
The working group is sharing the draft version of the updates to promote transparency and move toward a common understanding of how the new guidelines will impact GCP, giving consideration to the “wide and substantial impact” of ICH’s GCP guidance. ICH will open the draft updated guidelines for public consultation once the working group reaches Step 2 in the multi-stage ICH guideline development process.
ICH-E6 Good Clinical Practice (GCP) draft update


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