ArticleCost effectiveness and resource allocation : C/E2021
The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality.
Article in Cost effectiveness and resource allocation : C/E, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Visual analysis of quality management in Chinese drug clinical trials based on CiteSpace and COOC.Frontiers in medicine · 2025Pooled it
- Quality of Drug Clinical Trials in China: A Mixed Methods Research.Journal of evidence-based medicine · 2025Article
- Turnover intention and its related factors of clinical research coordinator in Hunan, China: a cross-sectional study.Scientific reports · 2024Article
- Review
- Analysis of job satisfaction among clinical research coordinators.Work (Reading, Mass.) · 2024Article
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3 authors.
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Abstract
objectiveThe changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.
methodsThis study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.
resultThe most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%. DISCUSSION: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.
conclusionThe clinical research coordinators' access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.
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