ArticleInternational journal of clinical oncology2025
A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.
Article in International journal of clinical oncology, 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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.
methodsFIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.
resultsThere were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (P = 0.003, Chi-square test). The number of patients was higher in Japan than in the US (P = 0.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (P < 0.001).
conclusionWe inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.
Indexed as
Identifiers
What 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.