The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8

TL;DR

This paper explains how clinical research practices are evolving to focus on quality and risk-based approaches, based on industry feedback.

Contribution

The paper introduces a framework to clarify and expand key concepts in clinical research quality based on industry input.

Findings

TransCelerate member companies identified Quality by Design and related concepts as areas needing clarification.

The framework aims to support a proactive, risk-based approach to clinical research quality.

Stakeholder engagement is emphasized as a critical component of the new GCP framework.

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) renovation of Good Clinical Practice (GCP) represents a philosophical shift in the conduct of clinical research away from a one-size-fits-all application to promoting a proactive, risk-based approach. The aim of this paper is to enhance the understanding of specific topics detailed in ICH E8 based on direct feedback from TransCelerate member companies who identified Quality by Design (QbD), Critical to Quality (CtQ), Fit for Purpose, and Stakeholder Engagement, as most changed and open to interpretation. The TransCelerate framework seeks to highlight and expand each of these central topics to support utilization and implementation of a strong foundation for quality in clinical development.

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