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- W3030316165 abstract "ObjectiveTo analyze the main factors affecting the compliance of the subjects in anti-hypertension drug clinical trials and explore the methods of compliance management.Methods18 clinical trials of anti-hypertension drug in Peking University People's Hospital from May 2007 to Dec. 2013 were summarized. The causes of drop-out in drug clinical trials were analyzed.ResultsAmong 614 cases, there were 44 drop-outs.13 drop-outs appeared in 6 international multi-center trials.The rate of drop-out cases due to personal reasons was 71% and was the main factor influencing drop-out. Drug and environment reasons were 18% and 11%, respectively.During recent years, the international development of drug clinical trials made the compliance requirements higher.ConclusionsCarrying out the compliance education to subjects and ensuring quality of clinical trial, informing fully consent to subjects, establishing a good doctor-patient relationship, and dealing actively with adverse events would improve the compliance of the subjects, which will enhance the quality of drug clinical trials.Key words: Clinical trial; Subject compliance; Anti-hypertension drug" @default.
- W3030316165 created "2020-06-05" @default.
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- W3030316165 date "2016-06-21" @default.
- W3030316165 modified "2023-09-23" @default.
- W3030316165 title "Analysis and countermeasures on defluxion cases in antihypertensive drug clinical trial" @default.
- W3030316165 doi "https://doi.org/10.3760/cma.j.issn.1006-1924.2016.03.004" @default.
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