| 我国医学期刊遵循临床试验注册制度的现状调查 |
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| 引用本文： | 恽佳欣,范晶晶,杨郁.我国医学期刊遵循临床试验注册制度的现状调查[J].编辑学报,2023(2):157-164. |
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| 作者姓名： | 恽佳欣 范晶晶 杨郁 |
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| 作者单位： | 南京医科大学第一附属医院《临床皮肤科杂志》编辑部;南京医科大学第一附属医院《江苏医药》编辑部:210029,南京 |
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| 摘 要： | 临床试验注册的目的是减少临床试验报告的偏倚,提高研究的透明度和科学性。本研究调查了我国258种医学核心期刊的稿约,57种(22.1%)期刊稿约中要求遵循临床试验注册制度,其中50种期刊提出了具体的著录要求。进一步深入探讨各期刊发表的随机对照试验(RCT)中临床试验注册号著录格式及内容的一致性和准确性,以及RCT撰写遵循CONSORT报告指南是否对著录注册号有影响。本研究结果表明目前我国医学期刊对临床试验注册和报告指南的遵循情况并不理想,报告注册的RCT仅占17.2%,仍存在对注册制度重视不足及执行不严格等问题,而期刊要求遵循CONSORT声明可能对RCT的注册有积极的影响。建议医学期刊遵循临床试验注册制度,提高对其的正确认识和重视,这需要期刊审稿人、编辑及作者的共同参与,通过提高临床试验注册的比例,进而提升研究的透明度。
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| 关 键 词： | 临床试验注册 医学期刊 随机对照试验 报告指南 |
A survey of the current status of Chinese medical journals following the clinical trial registration policies |
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| YUN Jiaxin,FAN Jingjing,YANG Yu.A survey of the current status of Chinese medical journals following the clinical trial registration policies[J].Acta Editologica,2023(2):157-164. |
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| Authors: | YUN Jiaxin FAN Jingjing YANG Yu |
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| Institution: | Editorial Board of Journal of Clinical Dermatology, the First Affiliated Hospital with Nanjing Medical University, 210029, Nanjing, China |
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| Abstract: | Clinical trail registration policies aims to reduce bias and improve the transparency and scientific validity of research. We investigate the instructions for authors of 258 medical journals in China to identify whether each journal adhere to trial registration policies. 57(22.1%) medical journals adhere to clinical trail registration policies, of which 50 journals provide specific requirements. We further demonstrate that the consistency and accuracy of the clinical trial registry numbers in randomized controlled trials(RCT), and whether the journals adherence to reporting guidelines impact the likelihood of reporting trail registry number. The results indicate that medical journals have a poor compliance of reporting guidelines and clinical trail registration policies, with only 17.2% of RCTs registered. Medical journals do not sufficiently pay attention to the registration and lack of strict implementation, and journals adherence to CONSORT increase the likelihood of RCT registration. It is recommended to follow the guidelines and trail registration policies for medical journals, increase the awareness and attention to the clinical trial registration. This requires the joint participation of journal reviewers, editors and authors, to improve the transparency of research by increasing the rate of clinical trial registration. |
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| Keywords: | clinical trial registration medical journals randomized controlled trials reporting guidelines |
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