Oklahoma State University Center for Health Sciences, Office of Medical Student Research, Tulsa, Oklahoma, USA.
University of Texas Medical Branch, Department of Internal Medicine, Galveston, Texas, USA.
J Trauma Stress. 2023 Apr;36(2):325-332. doi: 10.1002/jts.22911. Epub 2023 Feb 14.
Failures by researchers and clinicians to overcome barriers in veteran health-related research may result in clinical trial (CT) discontinuation and nonpublication. Such outcomes are a waste of limited academic resources. To determine rates of discontinuation and nonpublication among CTs for posttraumatic stress disorder (PTSD) with pharmaceutical interventions specific to the veteran population, we performed a systematic search of registered trials in ClinicalTrials.gov for pharmaceutical interventions for the treatment of PTSD. Extracted study characteristics included sample size, study design, trial status, phase, and funding source. Studies were classified as completed or discontinued based on the status listed in ClinicalTrials.gov. Descriptive statistics of trials were reported, and associations of trial termination and nonpublication were assessed using logistic regression. The final sample included 54 CTs, 15 of which (27.8%) had not been published within the FDA's required timeframe, and 11 (20.4%) were discontinued. The total number of trial participants was 3,463, with a median of 37 (interquartile range: 15-92). Of the 54 trials, 12 (22.2%) were nonrandomized, and 42 (77.8%) were randomized. There were 25 (46.3%) trials that were in either Phase 3 or Phase 4, and 39 (72.2%) were government-funded. We found high rates of CT discontinuation and nonpublication among PTSD pharmaceutical intervention studies in veterans, as has been shown in other fields of research.
研究人员和临床医生未能克服退伍军人健康相关研究中的障碍，可能导致临床试验（CT）中止和不发表。这种结果是对有限学术资源的浪费。为了确定针对退伍军人人群的创伤后应激障碍（PTSD）药物干预的 CT 中止和不发表的发生率，我们对 ClinicalTrials.gov 中注册的药物干预 PTSD 治疗的临床试验进行了系统搜索。提取的研究特征包括样本量、研究设计、试验状态、阶段和资金来源。根据 ClinicalTrials.gov 中列出的状态，将研究归类为完成或中止。报告了试验的描述性统计数据，并使用逻辑回归评估了试验终止和不发表的关联。最终样本包括 54 项 CT，其中 15 项（27.8%）未在 FDA 规定的时间内发表，11 项（20.4%）中止。试验参与者总数为 3463 人，中位数为 37（四分位距：15-92）。在 54 项试验中，12 项（22.2%）是非随机的，42 项（77.8%）是随机的。有 25 项（46.3%）试验处于第 3 阶段或第 4 阶段，39 项（72.2%）是政府资助的。我们发现退伍军人 PTSD 药物干预研究中的 CT 中止和不发表率很高，这在其他研究领域也有显示。
