The Development Safety Update Report
- PDF / 131,868 Bytes
- 6 Pages / 612 x 794 pts Page_size
- 101 Downloads / 162 Views
LEADING ARTICLE
ยช 2009 Adis Data Information BV. All rights reserved.
The Development Safety Update Report What can We Expect? Brian Davis Medicines and Healthcare products Regulatory Agency, London, UK
Abstract
This article gives an overview of the current status of the development safety update report (DSUR) guideline, provides a rationale for some of the key sections of the report and highlights the practical implications of its implementation for clinical trial sponsors and other parties. The DSUR aims to provide a periodic analysis of the evolving safety profile of an investigational drug, and actions proposed or being taken to address safety concerns during the clinical development of an investigational drug. The draft guideline, published for consultation in mid-2008 in the International Conference on Harmonisation regions of Europe, Japan and the US, is intended to be the common standard for the format, content and timing of annual safety reports to regulators, replacing existing reports such as the US investigational new drug annual report and the EU annual safety report.
The development safety update report (DSUR)[1] can help sponsors to identify potential safety issues early during the clinical development of an investigational drug. The recognition of safety issues is crucial to the ongoing assessment, management and communication of risk to subjects in clinical trials. It will also serve to notify regulators at regular intervals of the evolving safety profile of an investigational drug and actions proposed or being taken to address safety concerns. The term investigational drug is used in the guideline to indicate only the experimental product under study or development. The Council for International Organizations of Medical Sciences (CIOMS) VI[2] and VII[3] Working Groups noted that there are major differences between the requirements of the US investigational new drug (IND) annual report[4] and the EU annual safety report,[5] and recommended the development of a new, harmonized annual safety report for regulators. They provided recommendations regarding general principles behind a DSUR that would replace current reports. Subsequently, the International Conference on Harmonisation (ICH)[6] convened an expert working group to develop an ICH guideline on DSURs. A draft guideline,[1] published for consultation in mid-2008 in the ICH regions of Europe, Japan and the US, is intended to become the common standard for annual reports on clinical trial safety to regulators, replacing existing reports. By harmonizing the format, content and timing of annual safety reports, the DSUR will provide the same information at
the same time to regulators in the three ICH regions, thereby reducing the number of reports sponsors must generate for multinational trials. The information gathered for the DSUR may provide the basis for other reports. For instance, sponsors may use some information within a DSUR for a periodic safety update report (PSUR), they may generate development risk management plans during clinical
Data Loading...
