ArticleInternational journal of clinical oncology2015
Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?
Article in International journal of clinical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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Who cites it
24 citing papers in PubMed, 51 citations in OpenAlex.
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- 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
- A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.International journal of clinical oncology · 2025Article
- Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.International journal of clinical oncology · 2025Article
- Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology.Therapeutic innovation & regulatory science · 2024Article
- A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan.Patient preference and adherence · 2024Article
- Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study.Clinical and translational science · 2023Article
- Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.Therapeutic innovation & regulatory science · 2023Article
- Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020.Therapeutic innovation & regulatory science · 2023Article
- Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan.JAMA network open · 2023Article
- Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999-2019.International journal of clinical pharmacy · 2023Article
- Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan.Current oncology (Toronto, Ont.) · 2023Article
- How are new drugs disseminated in Japan? Analysis using the National Database of Health Insurance Claims of Japan.Cancer science · 2022Article
- Innovation drug approvals based on a bridging study: from concept to practice.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2022Review
- Assessment of Drugs Approved by Public Knowledge-Based Applications (Kouchi-shinsei) During the Last Two Decades in Japan.Clinical pharmacology and therapeutics · 2021Article
- Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.Clinical pharmacology and therapeutics · 2021Article
- Use of unapproved or off-label drugs in Japan for the treatment of graft-versus-host disease and post-transplant viral infection.International journal of hematology · 2020Article
- Harmonization of Cardiovascular and Oncology and the Blossoming of Cardio-Oncology in Japan.JACC. CardioOncology · 2020Article
- Breast cancer survival among Japanese individuals and US residents of Japanese and other origins: a comparative registry-based study.Breast cancer research and treatment · 2020Article
- Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.Investigational new drugs · 2019Article
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan.
methodsWe comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag.
resultsThis study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: "Japan's participation in global clinical trials"; "bridging strategies"; "designation of priority review in Japan"; and "molecularly targeted drugs".
conclusionsFrom 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan's taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.
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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.