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USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials

The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good Clinical Practice (GCP)" with updated recommendations for good clinical practices (GCPs), which aim to modernize clinical trial design and conduct without compromising data integrity or participant safety.

Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants.

The Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected.

This update aims to facilitate more efficient clinical trials to facilitate medical product development.

This draft guideline was adapted from the International Council for Harmonisation's (ICH) recently revised E6(R3) draft guideline developed to accommodate rapidly evolving technological and methodological innovations.

The updated draft recommendations aim to be suitable for various clinical trials, including those incorporating innovative design features. These features have the potential to enhance trial efficiency and reduce the overall burden.

Moreover, the updated guidelines for Good Clinical Practice (GCP) promote the adoption of suitable and innovative digital health technologies (DHTs) for specific purposes.

Click this LINK to know more about the Trial Design, Selection of Participants, etc...


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