Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology

Maki, Akio; Narukawa, Mamoru

doi:10.1007/s43441-024-00655-0

Ther Innov Regul Sci

2024

DOI: 10.1007/s43441-024-00655-0

|View full text |Cite

Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology

Akio Maki,

Mamoru Narukawa

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

Supporting

Mentioning

Contrasting

Year Published

2024

Publication Types

Select...

Preprint1

Relationship

Self Cite0

Independent1

Authors

Journals

Cited by 1 publication

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Evaluation of Drug Lag and Drug Loss in Japan: Participation in Global Phase III Oncology Trials

Shiga,

Shibata,

Miyata

2024

Preprint

View full text Add to dashboard Cite

Background: Despite efforts to mitigate drug lag, discrepancies in drug approval timelines persist between Japan and the US, and increase in unapproved drugs has become a significant challenge. This study aimed to evaluate potential drug lag and drug loss by assessing Japan's participation in global phase III multinational/multiregional clinical trials (MRCTs) targeted cancers. Methods: Phase III MRCTs of anticancer drugs initiated between 2008 and 2022 were collected. Information of participant countries, study sponsor, study design, and cancer type were collected and analyzed by. logistic regression analysis to identify factors affected Japan’s participation. Results: Of 999 phase III MRCTs, Japan's participation every 5 year increased over 15 years (2008-2012: 34.3%, 2013-2017: 51.6%, 2018-2022: 60.2%), while Japan’s non-participation numbers didn’t change (2008-2012: 157, 2013-2017: 167, 2018-2022: 165). In the multivariate logistic regression analysis, the absence of an operational base in Japan and minor cancers were negatively associated with Japan’s participation in phase III MRCTs. Japan’s participation was also associated with some cancer organs and drug modalities. Conclusion: Potential future drug lag and increases of unapproved drug were expected to increase. Since inclusion of Japan in MRCTs results in shorter or no approval lag, Japan should promote to make the circumstances where small overseas companies can include Japan in MRCTs.

show abstract

Evaluation of Drug Lag and Drug Loss in Japan: Participation in Global Phase III Oncology Trials

Shiga,

Shibata,

Miyata

2024

Preprint

View full text Add to dashboard Cite

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology

Cited by 1 publication

References 29 publications

Evaluation of Drug Lag and Drug Loss in Japan: Participation in Global Phase III Oncology Trials

Evaluation of Drug Lag and Drug Loss in Japan: Participation in Global Phase III Oncology Trials

Contact Info

Product

Resources

About