Abstract
This article provides a critical review of the Step 2/3 International Conference on Harmonisation (ICH) E2F guidance on the Development Safety Update Report (DSUR) and examines its contents in relation to current requirements in the US and EU. The DSUR will provide a yearly update on the safety information for compounds in clinical development in addition to providing information on total exposure in the clinical trial programme, actions taken for managing safety risks and statements on the benefit-risk balance for clinical trials undertaken in the clinical development programme. The proposedDSURwill essentially cover all requirements of the existing periodic reports required during clinical development in the US and EU. The organization of the DSUR is similar to that of the postmarketing Periodic Safety Update Report but the DSUR will require additional fields and sources of data and it makes use of several region-specific appendices. Special attention is given in this article to challenges in implementing the DSUR concept including the varieties of data required, the amount of information from the DSUR to be provided to Ethics Committees and the impact of the incomplete international harmonization proposed by the ICH E2F guidance.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
The Council for International Organizations of Medical Sciences (CIOMS). Management of safety information from clinical trials. Geneva: CIOMS, 2005: 212
The Council for International Organizations of Medical Sciences (CIOMS). The Development Safety Update Report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Report of CIOMS Working Group VII. Geneva: CIOMS, 2006
ICH. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA3302.pdf [Accessed 2010 May 6]
Davis B. The development safety update report: what can we expect? Pharmaceut Med 2009; 23 (1): 19–24
Urushihara M, Kawakami K. Development safety update reports and proposals for effective and efficient risk communication. Drug Saf 2010; 33 (5): 341–52
ICH. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA4727.pdf [Accessed 2010 Jul 14]
EMEA/CHMP/ICH/309348/2008 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002827.pdf [Accessed 2010 Sep 17]
Federal Register 2008 Aug 5; 73 (151): 45462–3 [online]. Available from URL: http://www.access.gpo.gov/su_docs/fedreg/a080805c.html [Accessed 2010 Sep 10]
FDA. Code of Federal Regulations, title 21, section 312.33 [online]. Available fromURL: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.33 [Accessed 2010 Sep 10]
European Commission. Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use. April 2006 [online]. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-10/21_susar_rev2_2006_04_11_en.pdf [Accessed 2010 Sep 10]
PFSB notification no. 0229011, 2008 Feb 29. Implementation of the ordinance on the partial revision of the Pharmaceutical Affairs Law Enforcement Regulations in relation to notifications of plans of clinical trials of drug substances and reporting of adverse drug reactions and infections related to clinical trials (revision of article 273 of PAL Enforcement 2008 Feb 29) [in Japanese, online]. Available from URL: http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/200306-b00.pdf [Accessed 2010 Sep 17]
PFSB notification no. 0229007, 2008 Feb 29. Enforcement of the ordinance on the partial revision of the Ordinance on the Standards for the Conduct of Clinical Trials of Medicinal Products (revision of article 20 of GCP ordinance 2008 Feb 29) [in Japanese, online]. Available from URL: http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/200306-a00.pdf [Accessed 2010 Sep 17]
CIOMS VII Working Group Report. Development Safety Update Report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Geneva: CIOMS, 2006: 46
CIOMS VII Working Group Report. Development Safety Update Report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Geneva: CIOMS, 2006: 70
FDA. Guidance for Clinical Investigators, Sponsors, and IRBs: adverse event reporting to IRBs — improving human subject protection [online]. Available from URL: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf [Accessed 2010 Jul 15]
CIOMS VII Working Group Report. Development Safety Update Report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials. Geneva: CIOMS, 2006: 85
Acknowledgements
The opinions expressed in this article are those of the author alone. The author is an employee of Eisai Co., Ltd, and was a member of the CIOMS VII Working Group. The author thanks Dr Valerie Simmons, Dr Ilona Surick and Dr Maria Vass for helpful comments provided during the preparation of this article. The author would like to acknowledge the hard work and deliberations of the CIOMS VII Working Group and participants in the ICH E2F topic in developing and refining the concept of the DSUR. No sources of funding were used to assist in the preparation of this article.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Geary, S. The Development Safety Update Report. Pharm Med 24, 271–279 (2010). https://doi.org/10.1007/BF03256825
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03256825