Development safety update reports and proposals for effective and efficient risk communication.
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.
Urushihara
Hisashi
H
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Kawakami
Koji
K
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration; D003142:Communication; D017277:Drug Approval / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D015507:Drugs, Investigational / Q000009:adverse effects*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods; D018570:Risk Assessment
D015507:Drugs, Investigational
JAMA. 1999 Mar 3;281(9):841-4
10071007
Drug Saf. 2006;29(8):657-73
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