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Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA.《FDAAA 实施十年后：ClinicalTrials.gov 与相应出版物之间试验报告的一致性》
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Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.临床试验注册、报告、发表及《美国食品药品管理局安全与创新法案》合规情况：对2012年美国食品药品管理局批准的新药进行横断面分析及排名
BMJ Open. 2015 Nov 12;5(11):e009758. doi: 10.1136/bmjopen-2015-009758.
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Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.FDAAA 前后支持 FDA 批准神经精神药物的临床试验的注册、结果报告和发表偏倚：一项回顾性队列研究
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Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study.遵守在 ClinicalTrials.gov 上报告临床试验结果的法律要求：一项队列研究。
Lancet. 2020 Feb 1;395(10221):361-369. doi: 10.1016/S0140-6736(19)33220-9. Epub 2020 Jan 17.
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Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.在 FDAAA 前后，支持 FDA 批准高风险心血管设备的关键临床试验的注册、发布和结果报告。
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Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.《美国食品药品监督管理局修正案法案》与试验注册、发表及结果报告的关联
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Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov-evaluation of a new tracking tool for the US clinical trial registry.ClinicalTrials.gov 上三十所英国大学临床试验报告表现-对美国临床试验注册新追踪工具的评估。
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Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.衡量临床试验透明度：对新批准药物和大型制药公司的实证分析
BMJ Open. 2017 Dec 5;7(12):e017917. doi: 10.1136/bmjopen-2017-017917.
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Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.临床研究中的统计学争议：方案、公开的临床试验注册库和出版物中主要结局指标的比较：以肿瘤学试验为例。
Ann Oncol. 2017 Apr 1;28(4):688-695. doi: 10.1093/annonc/mdw682.
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Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.临床实验结果在 ClinicalTrials.gov 上的强制性报告遵守情况：横断面研究。
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Nonregistration, Discontinuation, and Nonpublication of Randomized Trials: A Systematic Review.随机试验的未注册、中止及未发表情况：一项系统评价
JAMA Netw Open. 2025 Sep 2;8(9):e2524440. doi: 10.1001/jamanetworkopen.2025.24440.
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Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study.临床试验数据使用申请方案与相应出版物之间的一致性：一项横断面研究。
Clin Trials. 2025 Jun;22(3):279-288. doi: 10.1177/17407745241304355. Epub 2024 Dec 29.
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Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law.印度的临床试验注册情况：12%的药品监管试验未按法律要求进行注册。
Health Res Policy Syst. 2025 Feb 18;23(1):19. doi: 10.1186/s12961-025-01288-x.
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Protocol publication rate and comparison between article, registry and protocol in RCTs.随机对照试验中方案的发表率以及文章、注册信息与方案之间的比较。
BMC Med Res Methodol. 2025 Feb 1;25(1):31. doi: 10.1186/s12874-025-02471-y.
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Discordant Information on Blinding in Trial Registries and Published Research: A Systematic Review.试验注册库与已发表研究中关于盲法的不一致信息：一项系统综述
JAMA Netw Open. 2024 Dec 2;7(12):e2452274. doi: 10.1001/jamanetworkopen.2024.52274.
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Funding of evidence included within public comments submitted to inform Medicare national coverage determinations.提交的公众意见中包含的用于为医疗保险全国覆盖范围判定提供信息的证据的资金。
Health Aff Sch. 2024 May 13;2(6):qxae064. doi: 10.1093/haschl/qxae064. eCollection 2024 Jun.
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Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study.欧盟临床试验注册库中注册的临床试验结果的可获取性：横断面审计研究
BMJ Med. 2024 Jan 12;3(1):e000738. doi: 10.1136/bmjmed-2023-000738. eCollection 2024.
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Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study.新冠肺炎临床试验注册信息传播度（DIRECCT）：一项横断面研究。
BMC Med. 2023 Nov 29;21(1):475. doi: 10.1186/s12916-023-03161-6.
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A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels.一种从随机对照试验中推导不良事件发生率的新方法：改善获益-风险比理解和应用于药物标签的潜力。
Adv Ther. 2024 Jan;41(1):152-169. doi: 10.1007/s12325-023-02695-8. Epub 2023 Oct 19.
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Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study.ClinicalTrials.gov 中注册的非手术牙周治疗试验的报告特征：一项观察性研究。
J Comp Eff Res. 2023 Aug;12(8):e230058. doi: 10.57264/cer-2023-0058. Epub 2023 Jul 7.
本文引用的文献
1
Comparison of Clinical Trial Changes in Primary Outcome and Reported Intervention Effect Size Between Trial Registration and Publication.临床试验主要结局和报告干预效果大小在注册与发表之间的比较。
JAMA Netw Open. 2019 Jul 3;2(7):e197242. doi: 10.1001/jamanetworkopen.2019.7242.
2
Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。
Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.
3
Reporting of results in ClinicalTrials.gov and high-impact journals.在ClinicalTrials.gov和高影响力期刊上报告研究结果。
JAMA. 2014 Mar 12;311(10):1063-5. doi: 10.1001/jama.2013.285634.
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