Cris Bergerot, Research Consultant at City of Hope, shared on LinkedIn:
“Excessive administrative requirements have become a major challenge in oncology clinical trials, increasing costs, delaying research, and diverting valuable time away from patient care.
A new ESMO – ASCO consensus article published in JCO.
Journals JCOOA highlights how the updated ICH Good Clinical Practice guideline E6(R3) offers an important opportunity to streamline clinical research.
The article emphasizes three key priorities:
- Risk-proportionate processes: Align monitoring and documentation requirements with participant risks and the importance of the data collected.
- Reducing unnecessary complexity: Simplify administrative procedures that do not meaningfully contribute to patient safety or data integrity.
- Including stakeholder perspectives: Incorporate feedback from patients, investigators, and research teams to improve trial feasibility and efficiency.
Notably, references to streamlining clinical research increased from just 3 in GCP E6(R2) to 40 in E6(R3).
The message is clear: High-quality clinical research does not require unnecessary bureaucracy Teresa Amaral, Fabrice Andre, José Luis Pérez Gracia, Lisa Carey and Cols.”
Title: ESMO and ASCO Consensus on Good Clinical Practice Guideline E6(R3): A Step Forward Towards Streamlining Clinical Research
Authors: Jose Luis Perez-Gracia, Laura Levit, Miguel F. Sanmamed, Priyanka Sharma, Fabrice André, Christian Hosius, Binita Patel, Alessandra Nuti, Lisa Carey, Teresa Amaral
Other articles from Cris Bergerot on OncoDaily.