ICH Project Guideline Symposium on ICH E19 “Selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials”
January 30, 2024
The “Selective Approach to Safety Data Collection in Specific Late-Phase Clinical Trials Conducted Before or After Marketing Authorization,” discussed in ICH E19, reached Step 4 in September 2022 and was issued as a notice in May 2023.
The application of Selective Safety Data Collection (SSDC) is based on the principle of enabling efficient data collection in clinical trials while ensuring the safety of trial participants and gathering safety information that will be beneficial in the future; compliance with the laws and regulations of each country and region is required.The SSDC methodology is gaining attention as a “Risk Proportionate Approach” to safety data collection. As the use of this methodology is expected to increase in the future—particularly in clinical trials conducted during the late stages of development, both pre- and post-approval, such as long-term outcome studies—all members involved in clinical trials, including sponsors, regulatory authorities,and Investigator Sites, among others, must have a proper understanding of the underlying principles.
We recently held an ICH E19 Guideline Symposium with the aim of promoting a proper understanding of these guidelines.At this symposium, following an explanation of the ICH E19 Guideline, we presented case studies of SSDC-eligible trials conducted overseas, points to note regarding implementation and analysis, and actual initiatives in clinical settings, focusing on considerations for the application of SSDC.
Details regarding the program and other information for this briefing session are available on the PMDA website.