ArticleInternational journal of clinical oncology2025
Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.
Article in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Ethics as if Your Life Depended on It.Journal of empirical research on human research ethics : JERHRE · 2026Article
- Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026Article
- A scoping review of real-world data sources for retrospective oncology analysis in Japan.ESMO real world data and digital oncology · 2026Review
- Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan.Frontiers in pharmacology · 2025Article
- An Empirical Analysis of Anti-Cancer Drug Lags in South Korea.Inquiry : a journal of medical care organization, provision and financingArticle
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Authors and funding
3 authors.
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Abstract
backgroundDespite efforts to mitigate drug lag, discrepancies in drug approval timelines persist between Japan and the US, and increase in unapproved drugs has become a significant challenge. This study aimed to evaluate potential drug lag and drug loss by assessing Japan's participation in global phase III multinational/multiregional clinical trials (MRCTs) targeted cancers.
methodsPhase III MRCTs of anticancer drugs initiated between 2008 and 2022 were collected. Information of participant countries, study sponsor, study design, and cancer type were collected and analyzed by logistic regression analysis to identify factors affected Japan's participation.
resultsOf 999 phase III MRCTs, Japan's participation every 5 years increased over 15 years (2008-2012: 34.3%, 2013-2017: 51.6%, 2018-2022: 60.2%), while Japan's non-participation numbers did not change (2008-2012: 157, 2013-2017: 167, 2018-2022: 165). In the multivariate logistic regression analysis, the absence of an operational base in Japan and minor cancers were negatively associated with Japan's participation in phase III MRCTs. Japan's participation was also associated with some cancer organs and drug modalities.
conclusionPotential future drug lag and increases of unapproved drugs were expected to increase. Since the inclusion of Japan in MRCTs results in shorter or no approval lag, Japan should promote to make circumstances where small overseas companies can include Japan in MRCTs.
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