ArticlePharmaceutical medicine2017
Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks.
Article in Pharmaceutical medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug-Related Deaths.Clinical and translational science · 2019Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access.
objectiveThis study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan.
methodsWe studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014. We focused on three different types of SRRAs: (1) all-SRRAs (i.e. SRRAs from domestic cases and other countries), (2) domestic-SRRAs (i.e. SRRAs from domestic cases) and (3) domestic unknown-SRRAs (i.e. SRRAs of unknown risks from domestic cases). Occurrences of the three types of SRRAs were analyzed using Kaplan-Meier analysis and Cox-regression.
resultsSRRAs tended to occur sooner for NMEs launched in recent years versus those launched towards the beginning of the study period. Risk of SRRA was high for antineoplastics. Drugs for cardiovascular diseases, central nervous system, and diabetes had positive associations with all-SRRAs, but the associations were weaker with domestic-SRRAs. Domestic-SRRAs were more likely for drugs with relatively novel modes of action (MOAs). Longer lag to Japanese launch after first global launch significantly lowered SRRA risks. While most of the variables showed similar associations across the three types of SRRAs, adoption of bridging strategies showed higher risks only for domestic-SRRAs, not for all-SRRAs. FDA safety labeling changes and non-orphan priority review drugs presented higher domestic-SRRA risks. The number of adverse drug reactions (ADRs) from spontaneous reports had positive correlations with the three types of SRRAs, whereas the number from company-led surveillance showed no association.
conclusionsOur results indicated that global clinical development pathways and marketing status should be considered more seriously in implementing locally optimized pharmacovigilance activities. Caution may be needed not only for drugs with novel MOAs, but also for drugs for which local dose-finding studies have been skipped, expedited review status has been given, timing of launch is close to those in the USA and the EU, and spontaneous reports rather than company-lead surveillance suggest possible safety risks.
Identifiers
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Registered trials
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