Lu J, Xu B B, Shen L L, Zheng C H, Li P, Xie J W, Wang J B, Lin J X, Chen Q Y, Huang C M
Department of Gastric Surgery, Fujian Medical University Union Hospital, Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fuzhou 350004, China.
Zhonghua Wai Ke Za Zhi. 2022 May 1;60(5):479-486. doi: 10.3760/cma.j.cn112139-20210730-00338.
To analyze the current development status of gastric cancer (GC) randomized controlled trials (RCT) between 2000 and 2019, and to review the basic characteristics of published RCT. ClinicalTrials.gov was searched for phase 3 or 4 RCT conducted between January 2000 and December 2019 with the keyword "gastric cancer", and the development trend of different types of RCT during different time periods was described. Basic features of registered RCT such as intervention, study area, single-center or multicenter, sample size, and funding were presented. PubMed and Scopus databases were searched to judge the publication status of studies completed until June 2016. The adequacy of the report was estimated by the Consolidated Standards of Reporting Trials (CONSORT) checklist. Design flaws were evaluated by Cochrane tool and/or whether a systematic literature review was cited. The data was analyzed by χ test or Fisher exact test. There were 262 RCT including in the present study. The number of GC-RCT registered on ClinicalTrials.gov had been on the rise from 1 case in 2000 to 30 cases in 2015. The proportion of RCT associated with targeted therapy or immunotherapy increased from 0 during 2000-2004 to 37.1% (36/97) during2015-2019. The RCT registered in Asia was 191 cases, while that in non-Asia region was 71 cases. The proportion of multi-center RCT from non-Asia was higher than that from Asia (70.4% (50/71) . 50.3% (96/191), χ²=8.527, =0.003). The proportion of RCT published was 59.1% (81/137). Among the published RCT, 65 (80.2%) studies were reported adequately, but 63 (77.8%) studies had avoidable design limitations. Targeted therapy and immunotherapy have become research hotspots in the treatment of GC. At present, there are inadequate multicenter RCT in Asia, and the publication rate of RCT is low. A considerable number of published RCT are reported inadequately and have avoidable design flaws.
分析2000年至2019年间胃癌随机对照试验（RCT）的当前发展状况，并回顾已发表RCT的基本特征。在ClinicalTrials.gov上搜索2000年1月至2019年12月期间进行的3期或4期RCT，关键词为“胃癌”，描述不同时间段内不同类型RCT的发展趋势。呈现注册RCT的基本特征，如干预措施、研究地区、单中心或多中心、样本量和资金情况。搜索PubMed和Scopus数据库以判断截至2016年6月完成研究的发表状况。通过《报告试验的统一标准》（CONSORT）清单评估报告的充分性。通过Cochrane工具和/或是否引用系统文献综述来评估设计缺陷。采用χ²检验或Fisher精确检验进行数据分析。本研究纳入262项RCT。在ClinicalTrials.gov上注册的胃癌RCT数量从2000年的1项增至2015年的30项。与靶向治疗或免疫治疗相关的RCT比例从2000 - 2004年的0增至2015 - 2019年的37.1%（36/97）。在亚洲注册的RCT为191项，非亚洲地区为71项。非亚洲多中心RCT的比例高于亚洲（70.4%（50/71）对50.3%（96/191），χ² = 8.527，P = 0.003）。发表的RCT比例为59.1%（81/137）。在已发表的RCT中，65项（80.2%）研究报告充分，但63项（77.8%）研究存在可避免的设计局限性。靶向治疗和免疫治疗已成为胃癌治疗的研究热点。目前，亚洲多中心RCT不足，RCT发表率低。相当数量已发表的RCT报告不充分且存在可避免的设计缺陷。
