Relationship between drug lag and factors associated with clinical trials in Japan

Ohwaki, Kenji; Nakabayashi, Tetsuo

doi:10.1111/jcpt.12202

Cited by 16 publications

(13 citation statements)

References 10 publications

(13 reference statements)

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“…Recent data confirm that regulatory and clinical development strategies including Japanese patients in pivotal multiregional clinical trials reduce the drug lag considerably, with shortened regulatory review, as well as shorter clinical development times. [72][73][74]…”

Section: Approval Timesmentioning

confidence: 99%

Clinical Development and Initial Approval of Novel Immune Checkpoint Inhibitors in Oncology: Insights From a Global Regulatory Perspective

Serrano

Hartmann²,

Schmitt

et al. 2018

Clin Pharma and Therapeutics

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Immune checkpoint inhibitors (ICI) have demonstrated meaningful patterns of clinical efficacy across various cancers. During their development, novel regulatory strategies and clinical design approaches were explored. This metrics-based narrative review examines submission strategies and clinical evidence expectations of the US, European, and Japanese drug agencies, as well as their impact on approval and overall development times. Also discussed is the role of emerging clinical science and biomarker evaluation to get the first six ICI initially approved.

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Section: Approval Timesmentioning

confidence: 99%

Clinical Development and Initial Approval of Novel Immune Checkpoint Inhibitors in Oncology: Insights From a Global Regulatory Perspective

Serrano

Hartmann²,

Schmitt

et al. 2018

Clin Pharma and Therapeutics

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“…In Japan, approval of a new drug abroad that is not approved for use in Japan has become a major issue [1][2][3][4][5][6][7][8]. This problem has been termed drug lag, and its direct cause includes delays in the start of clinical development, the progress of clinical trials, and in the regulatory review.…”

Section: Objectivementioning

confidence: 99%

“…To date, several studies have compared the review times in Japan to those in the US or Europe Union (EU), or investigated the relationship between review times, components of new drug applications (NDAs), regulatory agencies, and features of pharmaceutical companies in Japan [2,3,5,6,8]. However, to our knowledge, no studies have focused on new drugs that had exceptionally prolonged review times or closely examined the reasons for the prolonged review times in these cases.…”

Section: Objectivementioning

confidence: 99%

What Factors Lead to Prolonged Regulatory Review Times for New Drugs in Japan?

Yoneda¹,

Asada

Shimizu³

et al. 2015

J Clin Trials

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Objective: Among all the new drugs approved in Japan, the regulatory review time for some greatly exceeds the median each year. However, to our knowledge, no reports have detailed why the review times were prolonged in these instances. In this study, we examined new applications (NDAs) whose review times were more than twice as long as the median each year in order to pinpoint the cause of delayed approval. Methods:We analyzed 564 NDAs that were approved in Japan between 2005 and 2011.Results: Thirty-eight NDAs were found to have prolonged review times. Of the 38 NDAs, the most popular therapeutic categories were oncology drugs and vaccines, and 28 of the drugs had already been approved in foreign countries when approval was granted in Japan, some with lag times of more than 36 months. This observation suggests that prolonged regulatory review time further worsens lags in drug approval. "Problem related to clinical data" was cited as the most common reason for prolonged review time. For most of the NDAs categorized into this group, additional clinical trials were conducted during the same review time without NDA withdrawal because the clinical study design was inappropriate, a deficiency in the evidence of a dosage regimen was observed, or efficacy was not confirmed in a confirmatory study trial. Conclusion:Our analyses of these trial details indicate the importance of determining the optimal dosage regimen carefully and utilizing objective endpoints in clinical trials.Keywords: Regulatory review; Drug development; Clinical trial; Drug lag; New drug applications; Regulatory review times; Access gap ObjectiveIn Japan, approval of a new drug abroad that is not approved for use in Japan has become a major issue [1][2][3][4][5][6][7][8]. This problem has been termed drug lag, and its direct cause includes delays in the start of clinical development, the progress of clinical trials, and in the regulatory review. In order to minimize these delays, the Japanese regulatory authorities, the Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA), have conducted several projects [9]. As a result, the PMDA has shortened the average review time to

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“…Subsequently, it will be important to promote proper use of such NMEs. Previous reports have highlighted the associations between launch lag and adverse drug reactions, 17 DL and drug development strategy and clinical study data package, 18 and between DL and the frequency of safety measures by regulatory authorities. 19 However, no investigation has yet been conducted on the influence of DL on Japanese package inserts.…”

Section: Introductionmentioning

confidence: 99%