Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis.
Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis.
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试验方案中临床证据引用的完整性：横断面分析。
DOI：
10.1016/j.medj.2022.03.002
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Kimmelman,Jonathan
中科院分区：
文献类型：
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作者：
Sheng,Jacky;Feldhake,Emma;Zarin,DeborahA;Kimmelman,Jonathan
背景人类保护政策要求评估拟议的临床试验与先前和正在进行的测试类似假设的研究之间的关系。我们评估的程度，临床试验协议引用相关的已发表和正在进行的临床试验，将很容易获得与reference search.MethodsWe创建了一个随机样本的试验协议使用ClinicalTrials.gov，分层的行业和非行业赞助的研究。然后，我们进行了参考文献检索，以确定在何种程度上，协议引用的临床试验相同的干预，适应症配对，可在PubMed和ClinicalTrials.gov在试验启动时，FindingsOf 101试验方案评估，73至少有一个确定的可引用的试验。没有一个包含提示系统检索相关临床证据的声明。在至少有一项确定的可引用试验的行业申办的试验方案中，23例中有7例（30.4%）未引用任何已发表的临床试验，33例中有10例（30.3%）未引用任何正在进行的相关试验。非行业赞助的试验协议，至少有一个确定的可引用的试验，5 28（17.9%）没有引用任何已发表的临床试验和14 19（73.7%）没有引用任何正在进行的trials.ConclusionsClinical试验协议引用访问，相关的试验，并没有记录相关的临床试验的系统搜索。因此，如果伦理审查委员会审查类似于存放在ClinicalTrials.gov.Funding上的协议，他们往往会收到一个不完整的研究前景图片。这项研究由加拿大卫生研究所和格林沃尔基金会资助。
BackgroundHuman protection policies require assessment of how proposed clinical trials relate to prior and ongoing studies testing similar hypotheses. We assessed the extent to which clinical trial protocols cited relevant published and ongoing clinical trials that would have been easily accessible with reference searches.MethodsWe created a random sample of trial protocols using ClinicalTrials.gov, stratifying by industry and non-industry-sponsored studies. We then conducted reference searches to determine the extent to which protocols cited clinical trials with identical intervention-indication pairings that were accessible in PubMed and ClinicalTrials.gov at the time of trial initiation.FindingsOf the 101 trial protocols evaluated, 73 had at least one identified citable trial. None contained statements suggesting a systematic search for relevant clinical evidence. Of industry-sponsored trial protocols with at least one identified citable trial, 7 of 23 (30.4%) did not cite any published clinical trials and 10 of 33 (30.3%) did not cite any ongoing relevant trials. Of the non-industry-sponsored trial protocols with at least one identified citable trial, 5 of 28 (17.9%) did not cite any published clinical trials and 14 of 19 (73.7%) did not cite any ongoing trials.ConclusionsClinical trial protocols undercite accessible, relevant trials and do not document systematic searches for relevant clinical trials. Consequently, ethics review committees often receive an incomplete picture of the research landscape if they review protocols similar to those deposited on ClinicalTrials.gov.FundingThis study was funded by the Canadian Institutes of Health Research and the Greenwall Foundation.