ICH Project ICH E19 "Selective Approaches to Collect Safety Data in Certain Clinical Trials Conducted Before or After Approval in the Late Phase of Development" Guideline Symposium
January 30, 2024
"Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted Before or After Approval in the Late Phase of Development" 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 efficient data collection in clinical trials while ensuring the safety of trial participants and enabling the collection of useful safety information in the future, and must comply with the laws and regulations of each country and region. The SSDC approach is attracting attention as a risk-proportionate approach to safety data collection, and the number of studies using this approach is expected to increase, especially in clinical trials conducted before and after approval in the later stages of development, such as long-term outcome studies. Therefore, it is necessary for all members involved in clinical trials, including sponsors, regulatory authorities, and medical institutions, to properly understand the basic concept.
The ICH E19 Guideline Symposium was held this time to promote appropriate understanding of this guideline. In this symposium, after explanation of the ICH E19 Guideline, we introduced examples of SSDC adaptation studies conducted overseas, points to be considered when introducing and analyzing SSDC, and actual efforts in the medical field, focusing on points to be considered when applying SSDC.
The program and other details of this meeting can be found on the PMDA website.