GCP Is Becoming More Pragmatic: What Does This Imply?

The landscape of clinical trials is undergoing rapid transformation, driven by the emergence of new technologies and innovative methodological approaches. This evolving context is the reason for the third revision of Good Clinical Practice (GCP), ensuring that these advances are adequately reflected within the regulatory framework. The revised version is in

tended to remain sufficiently adaptable to accommodate future developments, including complex trial designs such as platform trials and basket trials.

Consequently, GCP is shifting toward a more flexible and pragmatic approach to its application. In this context, “pragmatism” entails that sponsors first make a comprehensive risk assessment, followed by the identification of critical-to-quality factors. Based on this evaluation, processes should be tailored to be fit for purpose, ensuring compliance with GCP requirements while maintaining efficiency.

More specifically, risk-based decision-making allows sponsors to determine the appropriate extent of essential document collection, investigational product accountability, and study team training. This principle is reflected in ICH-GCP E6 (R3), where essential records are no longer prescribed as a fixed list but are instead presented as a flexible and non-exhaustive framework that can be adapted to the specific characteristics of each study.

Nevertheless, the requirement for thorough documentation remains paramount, consistent with the longstanding principle that “if it is not documented, it did not occur.” Accordingly, a robust risk assessment should be conducted at the earliest stages of the study, particularly during the initiation phase, to identify critical-to-quality factors. This assessment informs how GCP principles will be operationalized throughout key aspects of the trial, including protocol development and vendor selection.

If you want to know how to identify Critical-to-Quality factor based on your Global Risk Assessment, please contact me.

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