Department of Psychiatry and Behavioral Sciences, College of Osteopathic Medicine, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Subst Abus. 2022;43(1):906-912. doi: 10.1080/08897077.2021.2010261.
With approximately 15 million individuals in the United States meeting criteria for Alcohol Use Disorder (AUD), advancing effective medication-assisted treatment options is crucial. This advancement stems from the publication of clinical trial (CT) results. The primary objective of this study was to assess the rates of discontinuation and non-publication of results in CTs focused on the pharmacologic treatment of AUD and to assess associated factors. : A cross-sectional study was completed after acquiring trials focused on AUD within the ClinicalTrials.gov database. Inclusion criteria for CTs were the use of a pharmaceutical intervention with an outcome measure of alcohol intake or craving, conducted between October 2008 through September 2018. The primary outcome measures were the frequency of trial discontinuation and non-publication. Discontinuation was assessed as the listed on ClinicalTrials.gov. Publications were identified through verification of listings on ClinicalTrials.gov, or via searches of PubMed, Embase, and Google Scholar. If publications were not found, correspondence to trial contacts were sent. Data analysis occurred on December 5th, 2020. Of 235 trials returned from the search, 87 met inclusion criteria. Our study found that 12.6% (11) of CTs involving pharmaceutical treatments for AUD were prematurely terminated, and 39.1% (34) had no published results. Recruitment and lower cutoff of targeted age groups were significantly associated with discontinuation and non-publication, respectively. Scientific evidence advances faster when all results are known-furthering the progress of positive studies, while avoiding duplicative efforts to test the same hypotheses with the same methods, thereby reducing scientific waste. Given the number of unpublished AUD trials, potentially useful information regarding treatment for individuals with AUD may be inaccessible to clinicians while also adding to the abundance of research waste.Key points What are the rates of discontinuation or non-publication of clinical trials for pharmacological treatments for AUD and associated factors? Among 87 trials, 11 (12.6%) were prematurely terminated and 34 (39.1%) did not reach publication, with trials that included participants 21 years and older more likely to reach publication than those with younger participants. Low publication rates of CTs for pharmacological treatments of AUD may (1) stunt the advancement of AUD research, (2) decrease the value in funding AUD research from government entities, and (3) needlessly expose participants to potentially harmful interventions.
在美国，大约有 1500 万人符合酒精使用障碍（AUD）的标准，因此推进有效的药物辅助治疗方案至关重要。这一进展源于临床试验（CT）结果的公布。本研究的主要目的是评估专注于 AUD 药物治疗的 CT 中停药和结果未发表的比率，并评估相关因素。
这是一项横断面研究，在 ClinicalTrials.gov 数据库中获取 AUD 相关试验后完成。CT 的纳入标准为使用药物干预，以酒精摄入量或渴望为结果测量指标，在 2008 年 10 月至 2018 年 9 月之间进行。主要结局指标是试验停药和未发表的频率。停药是根据 ClinicalTrials.gov 上列出的原因评估的。通过在 ClinicalTrials.gov 上验证清单，或通过搜索 PubMed、Embase 和 Google Scholar 来确定出版物。如果未找到出版物，则向试验联系人发送通信。数据分析于 2020 年 12 月 5 日进行。
从搜索中返回的 235 项试验中，有 87 项符合纳入标准。我们的研究发现，涉及 AUD 药物治疗的 CT 中有 12.6%（11 项）提前终止，39.1%（34 项）没有发表结果。招募和目标年龄组的较低截止值分别与停药和未发表结果显著相关。
当所有结果都已知时，科学证据会更快地推进，从而促进阳性研究的进展，同时避免用相同的方法重复测试相同的假设，从而减少科学浪费。鉴于未发表的 AUD 试验数量，可能会使临床医生无法获得有关 AUD 患者治疗的有用信息，同时也会增加大量的研究浪费。
关键要点
AUD 药物治疗的临床试验的停药或未发表率及其相关因素是什么？
在 87 项试验中，有 11 项（12.6%）提前终止，有 34 项（39.1%）未达到发表水平，参与者年龄在 21 岁及以上的试验比参与者年龄较小的试验更有可能达到发表水平。AUD 药物治疗 CT 的低发表率可能会（1）阻碍 AUD 研究的进展，（2）降低政府实体对 AUD 研究的资助价值，（3）不必要地使参与者接触到潜在有害的干预措施。
