Drug Clinical Trials. Good Clinical Practice new version published

The Guideline for Good Clinical Practice (GCP) E6(R3), published on 6 January 2025 by the International Council for Harmonisation (ICH) in its final version, introduces important updates as compared to its previous version (E6(R2)).
These changes were thought to improve the quality of the clinical trials, increase their efficiency and better adjust them to the rapid scientific and technologic advancement in the field of clinical research. Moreover, it is in line with Regulation EU 2014/536, regulating clinical trials in the European Union, ensuring greater regulatory harmonisation.
Risk-based approach
E6(R3) stresses the importance of a risk-based approach in the planning and conduct of clinical trials. This allows the concentration of resources on critical risks that may affect the safety of participants and data integrity, reducing at the same time complexity and costs with no impact on quality.
The new version acknowledges the growing use of digital technologies in clinical trials, as tools for remote monitoring and the collection of electronic data, wearable devices and applications for data collection directly from patients, as well as electronic management systems improving traceability and transparency.
Regulation EU 2014/536 also supports the adoption of digital technologies, promoting the procedural simplification and supporting data collection.
E6(R3) is more focused on the involvement of the participants in the investigation, underlining the importance of designing clinical trials that are more accessible and less burdensome for patients. The stress is on the integration of the patients’ point of view into the trials design, and on the provision of clear and transparent information to obtain a more conscious informed consent.
Similarly, Regulation EU 2014/536 promotes the involvement of the participants, requiring more transparency in the information given to patients.
The guideline update
The updated guideline clarifies the responsibilities of sponsors, investigators, and other parties involved in clinical trials. It enhances the concept of “quality by design” to prevent quality issues at an early stage, underlines the importance of a suitable and continuous training for all professionals involved and introduces clearer requirements for the supervision of investigations conducted by CROs (Contract Research Organizations).
An innovative aspect is the focus on the sustainability of clinical trials, with the goal of minimising the environmental impact of research operations and promote a responsible use of resources.
The Guideline for Good Clinical Practice E6(R3) represents a significant step to align clinical trial practice to modern needs. The update reflects a commitment to improve quality, efficiency and ethics of clinical trials, ensuring at the same time the safety of participants as well as data robustness.
Integration with the Regulation
The integration with the principles of Regulation EU 2014/536 adds to the harmonisation of the clinical trial practice at international level. These changes require an adjustment of all stakeholders involved in clinical trials, with special reference to training and implementation of the new practices described in the guideline.
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