这说明这个RCT研究面临了一个巨大挑战。 Shortcoming VS randomized clinical trials ·RCT是临床研究的金标准-通常速度较慢,效率低下,仅局限于回答方案中所提到的问题,且试验方案一旦确定后,一般不再做调整。 ·A large sample size ·Long study duration ·Lack of p...
[2] Intention to treat and per protocol analysis in clinical trials. Nephrology (Carlton). 2020 Jul;25(7):513-517. [3] Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised control...
微观上,PICOT框架可以把研究方案庖丁解牛,逐一落实研究细节,The devil is in the details. SEPTRE是SPIRIT官方发布的一个一站式工具,可以在线完成方案生成和注册(对接ClinicalTrials.gov平台) 两篇来自于NEJM的小文章对发表于该杂志上的临床研究统计方法做了分类和汇总,大部分研究仍然离不开经典的统计分析方法(t检...
[6]Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001. 323(7303): 42-6. [7]Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group ran...
2. SeegerJD, Davis KJ, Iannacone MR, et al. Methods for external control groups for singlearmtrials or long-term uncontrolled extensions to randomized clinical trials. Pharmacoepidemiol Drug Saf. 2020;29(11):1382-1392. doi:10.1002/pds.5141 ...
突破传统局限:利用反事实框架精准估算 RCT 中治疗依从效果 《Contemporary Clinical Trials》:Using the counterfactual framework to estimate non-intention-to-treat estimands in randomised controlled trials: A methodological scoping review 编辑推荐: 在随机对照试验(RCT)中,意向性治疗(ITT)估计存在局限,无法反映...
GuidetowritingaClinicalTrialsProtocol AdaptedfromR&DInformationSheetNo.1a,UnitedBristolHealthcareNHSTrust DevelopedinconjunctionwithSouthamptonUniversityHospitalTrustR&DDept. Theaimofthisguideistohelpresearcherswiththecontentandstructureofprotocolsforclinicaltrials.It indicatestheinformationthatshouldgenerallybeincludedinaprot...
临床试验（RCT）标书写作指南
vs Placebo in the Treatment of Adults With Bipolar I/II Depression A Randomized Clinical Trial...
GuidetowritingaClinicalTrialsProtocol AdaptedfromR&DInformationSheetNo.1a,UnitedBristolHealthcareNHSTrust DevelopedinconjunctionwithSouthamptonUniversityHospitalTrustR&DDept. Theaimofthisguideistohelpresearcherswiththecontentandstructureofprotocolsforclinicaltrials.It indicatestheinformationthatshouldgenerallybeincludedinaprot...