临床试验与临床试验注册

《眼科学报》严格遵守关于临床试验和临床试验注册的国际规范。我们认为,准确的临床试验定义是指任何研究,其目的是前瞻性地将人类参与者纳入一个或多个与健康相关的干预措施中,以评估这些干预对健康结果的影响。

为保证临床试验的透明度和可重复性,我们的政策规定所有关于临床试验的手稿必须附带原始试验方案、完整的统计分析计划以及对方案和/或计划的任何修改说明。

我们推荐所有前瞻性临床试验和观察性临床研究在公认的注册平台上进行注册。注册确保了研究的可追溯性,并有助于避免不必要的重复研究和选择性报告。请在您的手稿方法部分详细说明临床试验的注册信息,包括注册的网站和注册编号。例如,您可以在国际临床试验注册平台http://www.clinicaltrials.gov、国际标准随机对照试验号码注册网站http://www.controlled-trials.com,或中国临床试验注册中心https://www.chictr.org.cn/进行注册。

遵守CONSORT(临床试验报告的统一标准)指南是提交临床试验报告的基本要求。所有临床试验的报告都应包含相应的CONSORT流程图和核对表。如果进行的是与原始临床试验相同人群的独立亚分析,可以引用原始试验的报告,而无需重复提交流程图和核对表。但是,如果亚分析涉及特定患者子集,我们建议提供相应的流程图和核对表以增强报告的完整性和透明度。

Clinical Trials and Clinical Trial Registration

Eye Science adheres strictly to international guidelines regarding clinical trials and clinical trial registration. We define a clinical trial as any research that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes.

To ensure transparency and reproducibility of clinical trials, our policy requires that all manuscripts related to clinical trials be accompanied by the original trial protocol, a complete statistical analysis plan, and any amendments made to the protocol and/or plan.

We recommend that all prospective clinical trials and observational studies be registered on recognized trial registration platforms. Registration ensures the traceability of research and helps prevent unnecessary duplication and selective reporting. Please provide detailed clinical trial registration information in the methods section of your manuscript, including the registration website and trial number. For example, you may register your trial on the International Clinical Trials Registry Platform at http://www.clinicaltrials.gov, the International Standard Randomized Controlled Trial Number registry at http://www.controlled-trials.com, or the Chinese Clinical Trial Registry at https://www.chictr.org.cn/.

Compliance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines is a fundamental requirement for the submission of clinical trial reports. All clinical trial reports should include the relevant CONSORT flow diagram and checklist. For independent sub-analyses conducted on the same population as the original trial, the original trial’s report may be cited without resubmitting the flow diagram and checklist. However, if the sub-analysis focuses on a specific subset of patients, we recommend providing the corresponding flow diagram and checklist to enhance the completeness and transparency of the report.

其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
    浏览