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Are randomized controlled trials being conducted with the right justification?
Journal of Evidence-Based Medicine ( IF 3.6 ) Pub Date : 2020-07-02 , DOI: 10.1111/jebm.12405
Corbin Walters 1 , Trevor Torgerson 1 , Ian Fladie 1 , Angela Clifton 1 , Chase Meyer 1 , Matt Vassar 1
Affiliation  

OBJECTIVE It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to combat research waste is to conduct randomized clinical trials (RCTs) only when a systematic review (SR) suggests more data are needed or when no previous SRs are identified. Here, we analyzed RCTs to determine whether SRs were cited as justification for conducting a trial. METHODS We analyzed phase III RCTs published between 2016 and 2018 in New England Journal of Medicine, Lancet, and JAMA. We performed duplicate and independent data extraction to ensure the accuracy and validity of our data. For each trial, we extracted whether SRs were cited as justification for conducting the clinical trial. RESULTS We examined 637 RCTs that cited 728 SRs. Overall, 38.1% (243/637) of RCTs cited an SR as either verbatim (6.9%, 44/637) or inferred (31.2%, 199/637) for trial justification. The 79 remaining RCTs cited SRs in other ways. Approximately, 49.5% (315/637) of RCTs did not cite a SR. CONCLUSIONS Less than half of the analyzed clinical trials cited a SRs as the basis for undertaking the trial. We believe trialists should be required to present relevant SRs to an ethics or peer review committee demonstrating an unmet need prior to initiating a trial. Eliminating research waste is both a scientific and ethical responsibility.

中文翻译:

是否以正确的理由进行了随机对照试验?

目的据估计,许多健康研究可能会被浪费掉,从而导致全世界每年数十亿美元的浪费性研究支出。鉴于越来越多的使用随机试验及其对医学的影响,一种应对研究浪费的方法是仅在系统评价(SR)建议需要更多数据或未确定以前的SR时进行随机临床试验(RCT)。在这里,我们分析了RCT,以确定是否引用SR作为进行试验的理由。方法我们分析了2016年至2018年在《新英格兰医学杂志》,《柳叶刀》和《美国医学会杂志》上发表的III期RCT。我们执行了重复且独立的数据提取,以确保数据的准确性和有效性。对于每个试验,我们提取是否将SR引用作为进行临床试验的理由。结果我们检查了637个RCT,引用了728个SR。总体而言,有38.1%(243/637)的RCT引用SR为逐字记录(6.9%,44/637)或推断为(SR)为试验依据(31.2%,199/637)。其余的79个RCT以其他方式引用了SR。大约49.5%(315/637)的RCT未引用SR。结论少于一半的分析临床试验引用了SRs作为进行试验的基础。我们认为,应要求审判者在开始审判之前向道德或同行评审委员会提交相关的SR,以证明需求未得到满足。消除研究浪费既是科学责任,也是道德责任。大约49.5%(315/637)的RCT未引用SR。结论少于一半的分析临床试验引用了SRs作为进行试验的基础。我们认为,应要求审判者在开始审判之前向道德或同行评审委员会提交相关的SR,以证明需求未得到满足。消除研究浪费既是科学责任,也是道德责任。大约49.5%(315/637)的RCT未引用SR。结论少于一半的分析临床试验引用了SRs作为进行试验的基础。我们认为,应要求审判者在开始审判之前向道德或同行评审委员会提交相关的SR,以证明需求未得到满足。消除研究浪费既是科学责任,也是道德责任。
更新日期:2020-07-02
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