caa a22 4500 605490597 CHVBK 20210128100505.0 cr unu---uuuuu 210128e20151201xx s 000 0 eng 10.1007/s10147-015-0825-4 doi (NATIONALLICENCE)springer-10.1007/s10147-015-0825-4 Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan? [Elektronische Daten] [Hideki Maeda, Tatsuo Kurokawa] Background: This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan. Methods: We 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. Results: This 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 875days (29.2months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281days (9.4months). 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”. Conclusions: From 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 1year. Japan Society of Clinical Oncology, 2015 Anticancer drug nationallicence Clinical development nationallicence Drug lag nationallicence Japan nationallicence Oncology nationallicence PMDA nationallicence Maeda Hideki Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, 105-8512, Tokyo, Japan aut Kurokawa Tatsuo Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, 105-8512, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/6(2015-12-01), 1072-1080 1341-9625 20:6<1072 2015 20 10147 https://doi.org/10.1007/s10147-015-0825-4 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-015-0825-4 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Maeda Hideki Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, 105-8512, Tokyo, Japan aut NATIONALLICENCE 700 1- Kurokawa Tatsuo Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, 105-8512, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/6(2015-12-01), 1072-1080 1341-9625 20:6<1072 2015 20 10147