ReviewClinical and translational science2026
Utilization of Healthy Volunteers in Oncology Drug Development in Japan: A 10-Year Analysis of Approved Anticancer Agents (2014-2024).
Review in Clinical and translational science, 2026. 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Anticancer agents with favorable safety profiles, such as immunomodulators and molecular-targeted agents, are increasingly used in recent cancer therapy, and clinical trials for these agents increasingly incorporate healthy volunteers as well as cancer patients. Clinical trials in healthy volunteers allow intensive safety monitoring and intensive pharmacokinetic sampling, enabling the acquisition of high-quality, broad-range pharmacokinetic and safety data within a shorter timeframe and at lower cost. Leveraging these advantages by utilizing healthy volunteer trials in place of patient trials may contribute to more rapid and efficient implementation of anticancer drug development and is expected to help eliminate the "drug lag" and "drug loss" that have been concerns in Japan's research and development process in recent years. In this study, we investigated the clinical data packages of newly approved anticancer agents in Japan from April 2014 to March 2024 and evaluated trends in cases in which data from Japanese healthy volunteers were obtained. We then summarized key considerations for anticancer drug development in Japan regarding whether data from Japanese healthy volunteers should be obtained.
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.