ArticleTherapeutic innovation & regulatory science2025
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundLess participation by Japan in multi-regional clinical trials (MRCTs) is one of concerns that leads to drug loss in Japan, but the characteristics of Japan's participation in MRCTs have not been well studied. PURPOSE: This study investigated Japan's situation in global drug development by characterizing its participation in MRCTs compared with East and South-East Asian countries/regions, with a focus on MRCTs sponsored by small-medium companies to discuss necessary measures in further promoting drug development in Japan.
methodsData from MRCTs conducted in East and South-East Asia during the period from January 1, 2013 to December 31, 2022 were analyzed.
resultsJapan's participation in MRCTs conducted in Asia (East Asia and South-East Asia) was limited. In particular, Japan participated in only 15-16% of MRCTs sponsored by Small/Medium-pharma (mainly US-based companies), with even less participation in Early Phase MRCTs. Japan's participation in MRCTs was markedly lower than other Asian countries/regions such as Singapore, South Korea, and Taiwan, although it was relatively higher in MRCTs that targeted neoplasms compared with other diseases.
conclusionResults of this study raise significant concern about future potential drug loss in Japan. It is urgent to increase the participation of Japan in MRCTs in order to continuously provide new globally developed drugs to patients in Japan. For that purpose, an integrated approach that includes continuous improvement in pharmaceutical regulations and the clinical trial environment, as well as market attractiveness, will be necessary in parallel with strengthening of collaborations between Japan and other Asian countries/regions.
Indexed as
Identifiers
40670856What OpenQuestion holds
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.