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Relationship between drug lag and factors associated with clinical trials in Japan
Author(s) -
Ohwaki K.,
Nakabayashi T.
Publication year - 2014
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12202
Subject(s) - clinical trial , medicine , drug , placebo , clinical study design , confidence interval , drug development , intensive care medicine , pharmacology , alternative medicine , pathology
Summary What is known and objective Drug lag is a major public concern in Japan. During the development of new drugs, some factors related to clinical trials in the marketing application package, such as trial design and the number of trials, can affect drug approval. The aim of this study was to determine whether those clinical trial factors were associated with drug lag in Japan. Methods We investigated new drug applications for new molecular entities that were approved in Japan between April 2009 and March 2012. We collected information on clinical trials in the marketing application package from review reports. Results and discussion We constructed a multiple regression model to predict drug lag using the review period, use of foreign clinical trial data, the number of confirmatory trials, the design of the pivotal trial, failures of confirmatory trials and the death rate ( n = 59). No use of foreign trial data was significantly associated with a longer drug lag (84% increase; 95% confidence interval [ CI ], 1·03–3·29). Compared to the open‐label, one‐armed design, drugs that underwent pivotal trials of placebo‐controlled superiority, active‐controlled superiority and active‐controlled non‐inferiority designs had a significantly shorter drug lag (74% decrease, 95% CI : 0·08–0·83; 74% decrease, 95% CI : 0·07–0·99; and 85% decrease, 95% CI : 0·04–0·58, respectively). What is new and conclusion Our findings suggest that new drug application packages that do not use data from foreign clinical trials and that involve pivotal trials of open‐label, one‐armed design contribute to drug lag in Japan. To reduce this lag, improved strategies for the development of new drugs should be identified.