A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.

ABSTRACT:

Background

This 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.

Methods

FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.

Results

There 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

SUBMITTER: Mukaida A 

PROVIDER: S-EPMC12474682 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature