ReviewInvestigational new drugs2025
Assessing the risks and benefits of investigational new drugs in adult phase-I oncology trials in China, 2013-2021.
Review in Investigational new drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
7 authors.
Funding
Abstract
Previous research shows that the benefits of phase-I oncology trials increased from 5 to 18% between 2000 and 2019 globally. However, the risk-benefit profile of phase-I trials in China is unclear. This study aims to analyze the risk-benefit profile of phase-I oncology trials in China and explore their correlation. We included adult phase-I oncology trials registered on the Chinese Clinical Trial Registry and Information Disclosure Platform between September 2013 and December 2021. Data on response rates and grade-3/4 adverse events were retrieved from PubMed, Google Scholar, and CNKI to assess their correlation. A total of 189 trials with 9591 patients were analyzed. The median response rate was 25.4% (IQR, 9.4-41.4%), and the overall incidence of grade-3/4 adverse events was 29.3% (IQR, 15.0-43.8%). No significant trends were observed over time. Subgroup analysis showed higher response rates in lymphoma (45.8%), cell therapies (80.0%), and biomarker trials (38.0%). Higher adverse event rates were seen in breast cancer (55.0%), chemical drugs (33.3%), cytotoxic drugs (73.3%), and combination therapies (35.7%). A weak correlation was found between response rates and grade-3/4 adverse events (ρ = 0.217; p = 0.003), with a moderate correlation in immunotherapy (ρ = 0.417; p < 0.001). This is the first assessment of early efficacy and safety signals of phase-I oncology trials in China. No significant temporal trends were identified. However, the correlation in immunotherapy suggests that higher benefits may be accompanied by greater risks.
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