ESMO and ASCO Consensus on Good Clinical Practice Guideline E6(R3): A Step Forward Towards Streamlining Clinical Research

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Abstract
The growing administrative burden associated with clinical research has become a major challenge for investigators and research teams, contributing to increased costs, delays in trial implementation, and reduced research efficiency. In response, the European Society for Medical Oncology (ESMO) and ASCO have led multiple initiatives aimed at streamlining clinical research, identifying unnecessary bureaucracy, and promoting more pragmatic, patient-focused approaches. In line with these initiatives from ESMO, ASCO, and other stakeholders, the recent ICH Good Clinical Practice (GCP) guideline E6(R3) has incorporated numerous changes to rationalize the administrative procedures in clinical research. The revised guideline places substantially greater emphasis on applying proportionality between processes and risks, the relevance of the data, and the reliability of results; avoiding unnecessary complexity and burden in clinical research; and incorporating input from investigators and patients into trial design and conduct. The guideline also clarifies several aspects of clinical trial operations, including informed consent procedures, reconsenting requirements, source documentation, and delegation practices, providing opportunities to reduce administrative burden without compromising participant safety or data integrity. Together, the initiatives led by ESMO, ASCO, and other stakeholders, alongside the principles embedded within GCP E6(R3), reflect the shared recognition that clinical research processes should focus on activities that protect data integrity and the rights and well-being of patients. Effective implementation of these principles will be critical for improving the efficiency, sustainability, and accessibility of clinical research.

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