ArticleTherapeutic innovation & regulatory science2023
Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.
Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 5 citations in OpenAlex.
- Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia.Therapeutic innovation & regulatory science · 2026Review
- Trends in and Determinants of Approval Lag for Anticancer Drugs in Japan and the US: Role of Multi-Regional Trials and Concurrent Approvals.Clinical and translational science · 2025Article
- Disparities in access to systemic therapies for patients with hepatocellular carcinoma: an analysis from the International Liver Cancer Association.The Lancet regional health. Europe · 2025Review
- Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology.Therapeutic innovation & regulatory science · 2024Article
- Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study.Clinical and translational science · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug lag in Japan has greatly decreased over the past decades; however, new instances of drug lag have appeared along with changes in the circumstances of oncology drug development. We aimed to investigate the factors associated with the approval lag for new oncology drugs between Japan and the United States (US) over the past decade by comparing approval dates and modalities, lead indications, approval types, and phase I strategies for earlier approval in Japan.
methodWe descriptively evaluated the characteristics of 117 new oncology drugs approved in either Japan or the US from January 1, 2011, to December 31, 2020.
resultsSeventy-one drugs were approved in Japan, 112 in the US, five only in Japan, and 46 only in the US. Interestingly, new oncology drugs were predominantly developed by the top 20 pharmaceutical companies in Japan; however, the opposite was true for drugs that were not yet approved in Japan. However, no clear trend was observed in the relationship between drug lag and the studied factors, except for the phase I strategy. There was a numerical but clear trend in which a higher percentage of phase I multiregional clinical trials (MRCTs) in the drug development strategy was observed for drugs with earlier approval in Japan.
conclusionParticipation in global drug development during the early stages, such as during phase I MRCTs, is one of the keys to successfully minimizing this new instance of drug lag in Japan.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.