ASCO and the European Society for Medical Oncology (ESMO) have released a joint consensus statement highlighting strategies to reduce administrative burden and streamline cancer clinical trials. The statement focuses on leveraging newly updated guidelines from the International Council for Harmonisation (ICH), the global organization that sets universal safety and quality standards for clinical trials, known as Good Clinical Practice (GCP).
The commentary, titled “ESMO and ASCO Consensus on Good Clinical Practice (GCP) Guidelines E6(R3): a Step Forward Towards Streamlining Clinical Research,” was published simultaneously in JCO Oncology Advances and ESMO Open. It breaks down the practical applications of the latest guidance update, known as ICH E6(R3), which modernizes international clinical trial standards.1
In recent years, the growing administrative load on research sites and clinical investigators has delayed trial startup, increased operational costs, and diverted critical time away from patient care. The authors note that these challenges often arise from unnecessary administrative complexity and overinterpretation of regulations by trial sponsors and contract research organizations.
Julie R. Gralow, MD, FACP, FASCO
“Excessive administrative burden in clinical research diverts valuable time and resources away from patient care and slows down the progress of innovative cancer therapies,” said Julie R. Gralow, MD, FACP, FASCO, ASCO’s Chief Medical Officer and Executive Vice President. “The updated guidelines provide a clear, risk-proportionate framework that allows research teams to strip away unnecessary complexity while upholding the highest standards for patient safety and data integrity. Together with ESMO, we are committed to turning these guidelines into practical solutions that make clinical trials more efficient and accessible worldwide.”
Key insights that ASCO and ESMO applauded in the new GCP guidelines include:
- Risk-Proportionate Management: Recommending monitoring and oversight that matches specific trial risks rather than applying broad, heavy-handed administrative requirements.
- Elimination of Duplicative Tasks: Clarifying trial documentation rules, such as eliminating redundant entry of informed consent data and restricting re-consenting requirements to updates that affect a patient’s decision to remain in a trial.
- Stakeholder-Informed Design: Emphasizing the integration of feedback from investigators, research staff, and patients into trial protocols to eliminate burdensome or impractical procedures.
The consensus statement represents an ongoing joint effort between ASCO and ESMO. In 2024, the organizations joined forces within the ESMO Industry Strategic Forum Streamlining Clinical Research Group, uniting leaders across academia, professional societies, and industry to advocate for practical solutions that modernize trial operations globally.
To view the full consensus statement, visit JCO Oncology Advances.1
REFERENCE
1. Perez-Gracia JL, Levit L, Sanmamed MF, et al: ESMO and ASCO consensus on good clinical practice guideline E6(R3): A step forward towards streamlining clinical research., JCO Oncol Adv. Published online October 28, 2026.
