Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
JAMA Netw Open. 2021 Sep 1;4(9):e2124760. doi: 10.1001/jamanetworkopen.2021.24760.
The results of numerous large randomized clinical trials (RCTs) have changed clinical practice in gastric cancer (GC). However, research waste (ie, unpublished data, inadequate reporting, or avoidable design limitations) is still a major challenge for evidence-based medicine.
To determine the characteristics of GC RCTs in the past 20 years and the presence of research waste and to explore potential targets for improvement.
DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study of GC RCTs, ClinicalTrials.gov was searched for phase 3 or 4 RCTs registered from January 2000 to December 2019 using the keyword gastric cancer. Independent investigators undertook assessments and resolved discrepancies via consensus. Data were analyzed from August through December 2020.
The primary outcomes were descriptions of the characteristics of GC RCTs and the proportion of studies with signs of research waste. Research waste was defined as unpublished data, inadequate reporting, or avoidable design limitations. Publication status was determined by searching PubMed and Scopus databases. The adequacy of reporting was evaluated using the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline checklist. Avoidable design limitations were determined based on existing bias or lack of cited systematic literature reviews. In the analyses of research waste, 125 RCTs that ended after June 2016 without publication were excluded.
A total of 262 GC RCTs were included. The number of RCTs increased from 25 trials in 2000 to 2004 to 97 trials in 2015 to 2019, with a greater increase among RCTs of targeted therapy or immunotherapy, which increased from 0 trials in 2000 to 2004 to 36 trials in 2015 to 2019. The proportion of RCTs that were multicenter was higher in non-Asian regions than in Asian regions (50 of 71 RCTs [70.4%] vs 96 of 191 RCTs [50.3%]; P = .004). The analysis of research waste included 137 RCTs, of which 81 (59.1%) were published. Among published RCTs, 65 (80.2%) were judged to be adequately reported and 63 (77.8%) had avoidable design defects. Additionally, 119 RCTs (86.9%) had 1 or more features of research waste. Study settings that included blinding (odds ratio [OR], 0.56; 95% CI, 0.33-0.93; P = .03), a greater number of participants (ie, ≥200 participants; OR, 0.07; 95% CI, 0.01-0.51; P = .01), and external funding support (OR, 0.22; 95% CI, 0.08-0.60; P = .004) were associated with lower odds of research waste. Additionally, 35 RCTs (49.3%) were referenced in guidelines, and 18 RCTs (22.2%) had their prospective data reused.
To our knowledge, this study is the first to describe the characteristics of GC RCTs in the past 20 years, and it found a research waste burden, which may provide evidence for the development of rational RCTs and reduction of waste in the future.
大量随机临床试验（RCT）的结果已经改变了胃癌（GC）的临床实践。然而，研究浪费（即未发表的数据、不充分的报告或可避免的设计缺陷）仍然是循证医学的主要挑战。
确定过去 20 年 GC RCT 的特点和研究浪费的存在，并探讨潜在的改进目标。
设计、设置和参与者：在这项关于 GC RCT 的横断面研究中，使用关键词“胃癌”，在 ClinicalTrials.gov 上搜索了 2000 年 1 月至 2019 年 12 月期间注册的 3 期或 4 期 RCT。独立研究人员进行了评估，并通过共识解决了差异。数据分析于 2020 年 8 月至 12 月进行。
主要结果是描述 GC RCT 的特点和存在研究浪费迹象的研究比例。研究浪费被定义为未发表的数据、不充分的报告或可避免的设计缺陷。通过搜索 PubMed 和 Scopus 数据库来确定出版状况。使用 CONSORT 报告指南检查表评估报告的充分性。根据现有的偏见或缺乏引用的系统文献综述来确定可避免的设计缺陷。在研究浪费的分析中，排除了 125 项在 2016 年 6 月后结束且未发表的 RCT。
共纳入 262 项 GC RCT。RCT 的数量从 2000 年至 2004 年的 25 项增加到 2015 年至 2019 年的 97 项，其中靶向治疗或免疫治疗的 RCT 增加更为显著，从 2000 年至 2004 年的 0 项增加到 2015 年至 2019 年的 36 项。非亚洲地区多中心 RCT 的比例高于亚洲地区（70.4%，71/101 RCT 与 50.3%，191/382 RCT；P=0.004）。研究浪费的分析包括 137 项 RCT，其中 81 项（59.1%）已发表。在已发表的 RCT 中，65 项（80.2%）被认为报告充分，63 项（77.8%）存在可避免的设计缺陷。此外，119 项 RCT（86.9%）有 1 项或多项研究浪费特征。研究设置包括盲法（比值比，0.56；95%置信区间，0.33-0.93；P=0.03）、更多的参与者（即≥200 名参与者；比值比，0.07；95%置信区间，0.01-0.51；P=0.01）和外部资金支持（比值比，0.22；95%置信区间，0.08-0.60；P=0.004）与较低的研究浪费可能性相关。此外，35 项 RCT（49.3%）被指南引用，18 项 RCT（22.2%）前瞻性数据被重复使用。
据我们所知，这是第一项描述过去 20 年 GC RCT 特点的研究，发现了研究浪费负担，这可能为未来合理设计 RCT 和减少浪费提供证据。
