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The small trial problem.小样本问题。
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Better design leads to better results - Importance of virological outcome design in clinical trials for antiviral treatment of coronavirus disease 2019.更好的设计带来更好的结果——2019冠状病毒病抗病毒治疗临床试验中病毒学结果设计的重要性。
Pediatr Investig. 2023 Jan 9;7(1):1-5. doi: 10.1002/ped4.12363. eCollection 2023 Mar.
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Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia.多中心、单盲、随机对照研究法评价法匹拉韦和那屈肝素治疗 COVID-19 肺炎的疗效和安全性。
Int J Infect Dis. 2023 Mar;128:355-363. doi: 10.1016/j.ijid.2022.12.039. Epub 2023 Jan 4.
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Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial.法匹拉韦与羟氯喹联合治疗中重度新型冠状病毒肺炎患者（FACCT试验）：一项开放标签、多中心、随机对照试验
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Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.瑞德西韦治疗成人重症 COVID-19 的随机、双盲、安慰剂对照、多中心临床试验。
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Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.羟氯喹治疗主要为轻症和中症的 2019 冠状病毒病患者：开放标签、随机对照试验。
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Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.高剂量与低剂量磷酸氯喹作为辅助治疗对住院的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染患者的影响：一项随机临床试验。
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2019冠状病毒病抗病毒疗法随机对照临床试验中样本量确定的重要性。

Importance of sample size determination for randomized controlled clinical trials for coronavirus disease 2019 antiviral therapies.

作者信息

Zhaori Getu

机构信息

Editorial Office of Pediatric Investigation, Beijing Children's Hospital Capital Medical University National Center for Children's Health Beijing China.

出版信息

Pediatr Investig. 2024 Jan 24;8(1):7-11. doi: 10.1002/ped4.12415. eCollection 2024 Mar.

DOI:10.1002/ped4.12415
PMID:38516140
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10951484/
Abstract

For the calculation of sample size for a randomized controlled clinical trial, choosing a proper, medium clinically meaningful difference in the size of the effect of the test and control interventions is important for avoiding too small or too large sample sizes.

摘要

对于随机对照临床试验的样本量计算而言，在试验性干预措施和对照性干预措施效果大小方面选择一个合适的、具有中等临床意义的差异，对于避免样本量过小或过大很重要。