The pharmaceutical and CRO industries are undergoing a radical shift in their approach to ensuring quality in the conduct of clinical trials that involves a more targeted, risk based approach to site monitoring and quality management. The primary goal of this shift is to improve the efficiency, effectiveness and quality of clinical trial research and the data generated together with improving patient safety. A significant impetus has been the recognition by regulatory agencies that traditional approaches to clinical trial monitoring are no longer sustainable in an era of global multinational studies. For example, data indicate that the 100% verification of source data has not delivered the anticipated increase in the effectiveness of clinical trial research. Recent technological advancements in electronic data handling have also enabled this revolution in clinical trial monitoring.
In June 2015 the ICH published the draft addendum to Good Clinical Practice (ICH-E6) and this addendum was finalized and published as ICH-E6 (R2) in November 2016, the first revision of these guidelines for 20 years. The focus of the addendum is on the need for a holistic quality management system for clinical trials. The quality management system must focus on the critical data and critical processes for clinical trials to ensure patient safety and data integrity. The monitoring of clinical trial clinical should be prioritized, systematic and risk based.
Patient Centric Monitoring is ICON’s methodology for the design and execution of an adaptive risk based monitoring strategy guided by risk assessment using ICONIK analysis. In the design and execution of the monitoring strategy, ICON puts the patient at the centre of decision making.