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Drug Safety

, Volume 33, Issue 5, pp 341–352 | Cite as

Development Safety Update Reports and Proposals for Effective and Efficient Risk Communication

  • Hisashi Urushihara
  • Koji Kawakami
Current Opinion

Abstract

The periodic safety reporting to regulatory authorities is globally harmonized for postmarketing medicinal products by the International Conference on Harmonisation (ICH) guidelines, and is being extended for investigational drugs. To facilitate effective safety risk communication regarding investigational drugs, and to reduce duplicate periodic reporting to the US and EU by sponsors during development programmes, standardized Development Safety Update Reports (DSURs) are to be implemented in the near future.

In this current opinion article, after extensively reviewing the relevant report from the CIOMS VII Working Group and the ICH draft guideline regarding DSURs, we discuss an effective and efficient approach to its application. To ensure effective risk communication, we recommend that DSURs be made available to all the ethics committees and participating investigators around the world for the purpose of continuing review during ongoing clinical trials.

Furthermore, in order to maintain the consistency and integrity of safety information throughout the life-cycle of a drug, we believe it would be substantially more prudent and efficient to start a single, integrated, life-cycle periodic safety report covering both development and postmarketing, as proposed by the CIOMS VII Working Group, rather than maintain separate DSURs and Periodic Safety Update Reports, which can overlap considerably in content. To this end, we believe that the international regulatory community should undertake the new initiative for integrated periodic reporting immediately.

Keywords

Risk Communication Safety Information Investigational Drug Safety Message Periodic Safety 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The authors wish to thank Kenji Miki and Shinichi Nishiuma for their helpful comments in the planning of this manuscript, Courtney Cummings for her editing of the manuscript, and the anonymous reviewers for their thoughtful advice in helping to improve the manuscript.

No funding was used to assist in the preparation of this current opinion article. Dr Urushihara is a paid contractor working as a consultant for Eli Lilly, Japan. Dr Kawakami has no potential conflicts of interest to declare that are directly relevant to the contents of this current opinion article.

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Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  1. 1.Department of Pharmacoepidemiology, Graduate School of Medicine and Public HealthKyoto University, Yoshida Konoe-cho, Sakyo-kuKyotoJapan

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