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摘要: 随机对照试验（ randomized controlled trial，RCT）是证实临床干预措施有效性的最佳研究手段。一项好的RCT应以具备临床意义、科学价值的主题为核心，重点关注干预及对照的设立、随机化方式及研究终点的选择。在实施过程中，把握伦理申请、研究注册、数据收集及研究定期审核等细节，从而保证研究的科学性及结果的可信度。Abstract: Randomized controlled trials (RCTs) provide the most valid means of establishing the efficacy of clinical therapeutics. A good RCT should be based on topics with clinical significance and scientific value, and focus on the establishment of intervention and control, the method of randomization and the selection of primary endpoints. During the implementation process, details such as ethics application, research registration, data collection and regular review of the research are of great value to ensure the scientificity of the trial and the credibility of the results.
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Key words:
- randomized controlled trial /
- intervention /
- randomization /
- primary endpoint
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[1] Shen KN, Fu WJ, Wu Y, et al. Doxycycline Combined With Bortezomib-CyclophosphamideDexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis:A Multicenter Randomized Controlled Trial[J]. Circulation, 2022, 145:8-17. [2] Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement:updated guidelines for reporting parallel group randomized trials[J]. Ann Intern Med, 2010, 152:726-732. [3] Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement:defining standard protocol items for clinical trials[J]. Ann Intern Med, 2013, 158:200-207. [4] Boutron I, Estellat C, Guittet L, et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments:a systematic review[J]. PLoS Med, 2006, 3:e425. [5] Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals:review and reanalysis[J]. BMJ, 2012, 345:e5840. [6] Glynne-Jones R, Glynne-Jones S. The concept and use of the neoadjuvant rectal score as a composite endpoint in rectal cancer[J]. Lancet Oncol, 2021, 22:e314-e326. -
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