ArticleJournal of evidence-based medicine2025
Quality of Drug Clinical Trials in China: A Mixed Methods Research.
Article in Journal of evidence-based medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.EClinicalMedicine · 2026Article
- Quality of Drug Clinical Trials in China: A Mixed Methods Research.Journal of evidence-based medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
aimThe quality of drug clinical trials is crucial for authorizing new drugs and fostering innovations in clinical practice. This study aimed to report the status, trends, and factors of the quality of drug clinical trials in China.
methodsThis mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders.
resultsThe No Action Indicated findings issued by the Food and Drug Administration increased from 43% from 2009-2015 to 88% from 2016-2022, whereas the Official Action Indicated findings decreased from 9% to 0% (p = 0.001). The Center for Food and Drug Inspection revealed that 12% of new drug applications in 2015-2017 were suspected of data fabrication, compared to only 0.6% failed to pass the inspection in 2022 (p < 0.001). Number of drug trials published by Chinese institutions in top medical journals increased from 1.3% in 2009 to 4.9% in 2022 (p for trend <0.001). Moreover, the number of clinical trial guidelines increased from approximately 10/year from 2015-2019 to 50-60/year from 2020-2022, number of internationally accredited ethics committees increased from 4 in 2009 to 82 in 2022, and over 130,000 individuals received training on the International Council for Harmonization guidelines. Interviews with stakeholders revealed a consensus on quality improvement, attributed to seven key factors, and highlighted further recommendations to enhance clinical trial quality in China.
conclusionsThe quality of drug clinical trials in China has significantly improved over the past decade, yet there remains scope for further enhancement.
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.