Center for Health Sciences, Oklahoma State University, Tulsa.
Department of Otolaryngology, Oklahoma State University Medical Center, Tulsa.
JAMA Otolaryngol Head Neck Surg. 2020 Feb 1;146(2):176-182. doi: 10.1001/jamaoto.2019.3967.
Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck cancer remains unclear.
To assess the rate of discontinuation or nonpublication of RCTs involving patients with head and neck cancer. This objective was measured by observing 3 domains: discontinuation of trial, nonpublication of trial data, and feasibility of contacting trial investigators of aforementioned trials.
For this study, the sample was derived using the ClinicalTrials.gov advanced search feature on March 18, 2019, to locate completed and discontinued RCTs pertaining to head and neck cancer registered before this date. Trials were analyzed to identify reasons for trial discontinuation and publication status of each trial. If publication status or reason for trial discontinuation was not allocated through the systematic search of ClinicalTrials.gov, the corresponding author was emailed to determine publication status.
After exclusions, 130 RCTs were included. Of these trials, 92 (70.8%) were completed and 38 (29.2%) were discontinued for various reasons. The most common reason for discontinuation of trials was committee recommendations. Of the 130 analyzed trials, 67 (51.5%) were published in a peer-reviewed journal and 63 (48.5%) were unpublished trials. Of the 92 completed trials, 55 (59.8%) were published and 37 (40.2%) remained unpublished 3 or more years after trial completion. Trials funded by other sources (private, nonprofit, or the National Institutes of Health) were more likely to reach publication than industry-funded RCTs (unadjusted odds ratio, 4.3 [95% CI, 1.3-14.0]; adjusted odds ratio, 4.1 [95% CI, 1.2-14.3]).
Of RCTs in head and neck cancer, 29.2% were discontinued and 40.2% completed trials never reached publication. The findings suggest that needs exist for RCT guidance of head and neck cancer. The reporting of reasons for trial discontinuation appears to be lacking, and trial publication rates were low. This study is relevant to many physicians and researchers because it identifies potential sources of decreased research productivity and ethics.
随机临床试验（RCT）在临床决策中起着重要作用，而这些试验的中止或未发表是令人担忧的原因。关于头颈部癌症的中止或未发表的 RCT 的程度仍不清楚。
评估涉及头颈部癌症患者的 RCT 中止或未发表的比率。通过观察 3 个领域来衡量这一目标：试验中止、试验数据未发表以及上述试验试验研究者的可行性联系。
在这项研究中，样本是通过 2019 年 3 月 18 日在 ClinicalTrials.gov 上的高级搜索功能获得的，以找到在此日期之前注册的与头颈部癌症有关的已完成和中止的 RCT。对试验进行了分析，以确定试验中止的原因和每个试验的发表状态。如果未通过对 ClinicalTrials.gov 的系统搜索确定试验的发表状态或中止原因，则向相应的作者发送电子邮件以确定发表状态。
经过排除，共有 130 项 RCT 被纳入。这些试验中，92 项（70.8％）已完成，38 项（29.2％）因各种原因中止。试验中止的最常见原因是委员会的建议。在 130 项分析的试验中，67 项（51.5％）在同行评议的期刊上发表，63 项（48.5％）为未发表的试验。在 92 项已完成的试验中，55 项（59.8％）已发表，37 项（40.2％）在试验完成后 3 年或更长时间仍未发表。由其他来源（私人，非营利或美国国立卫生研究院）资助的试验比工业资助的 RCT 更有可能达到发表水平（未调整的优势比，4.3 [95％CI，1.3-14.0]；调整后的优势比，4.1 [95％CI，1.2-14.3]）。
在头颈部癌症的 RCT 中，有 29.2％中止，有 40.2％完成的试验从未发表过。研究结果表明，对头颈部癌症的 RCT 指导存在需求。试验中止的原因报告似乎有所欠缺，试验发表率很低。这项研究与许多医生和研究人员有关，因为它确定了降低研究生产力和伦理学的潜在来源。
