Journal of evidence-based medicine · 2025
Quality of Drug Clinical Trials in China: A Mixed Methods Research.
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Chen Xiayan, Chu Hongling, Zhang Xiaofang, Li Huijuan, Meng Jiaxue, Wu Yangfeng
Аннотация
AIM: The 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.
METHODS: This mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders.
RESULTS: The 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.
CONCLUSIONS: The quality of drug clinical trials in China has significantly improved over the past decade, yet there remains scope for further enhancement.
METHODS: This mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders.
RESULTS: The 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.
CONCLUSIONS: The quality of drug clinical trials in China has significantly improved over the past decade, yet there remains scope for further enhancement.