As part of its commitment to ensuring high-quality, patient-centred cancer research, ESMO has submitted feedback to the European Medicines Agency (EMA) on Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice (GCP). This guideline is crucial in modernising oncology clinical trial methodologies, particularly in decentralised trials and real-world data (RWD) integration, while maintaining scientific rigor, patient safety and regulatory coherence.
ESMO’s Recommendations:
- Strengthening Investigator Oversight: ESMO emphasised the need for clear guidance on investigator responsibilities in decentralised cancer trials, ensuring accountability in settings where remote monitoring and digital health technologies (DHTs) are used. Maintaining rigorous oversight is crucial to ensure the quality and reliability of data in oncology clinical research.
- Ensuring Robust Data Security Measures: ESMO highlighted concerns around data integrity and privacy, stressing the importance of safeguards against data breaches, particularly in decentralised oncology trials where patient data is collected through digital tools.
- Enhancing Informed Consent in Digital Settings: With increased reliance on electronic consent (eConsent) and virtual patient interactions, ESMO called for explicit protections to prevent misunderstandings or diminished patient autonomy in digital consent processes. Cancer patients, particularly those in advanced or vulnerable health conditions, must have clear, transparent and ethically sound digital consent frameworks to support their participation in trials.
- Aligning with EU Regulations: ESMO urged greater consistency between ICH E6(R3) Annex 2 and existing EU frameworks such as the Clinical Trials Regulation (CTR) and GDPR, to avoid regulatory conflicts and ensure smooth implementation across cancer trial designs.
- Addressing Quality Assurance in Real-World Data Integration: ESMO advocated for robust validation criteria for RWD use in oncology research, ensuring data sources are reliable and aligned with regulatory standards. Strengthening the role of RWD in cancer trials will help accelerate innovation, improve trial design and enhance patient outcomes.
ESMO's contribution to this consultation is part of its broader efforts to shape regulatory frameworks that support scientifically sound and ethically responsible oncology research. By actively engaging with EMA and international regulatory bodies, ESMO remains committed to ensure that evolving cancer clinical trial methodologies enhance innovation while upholding patient safety, data integrity and research excellence.
For further information, please contact: publicpolicy@esmo.org.