Nikzad Newsha, Dalwadi Shraddha M, Ludwig Michelle S
School of Medicine, Baylor College of Medicine, Houston, TX, USA.
Department of Radiation Oncology, The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Contemp Clin Trials Commun. 2022 Aug 12;29:100978. doi: 10.1016/j.conctc.2022.100978. eCollection 2022 Oct.
Clinical trials are considered the gold standard of clinical research and are sought in the medical literature for the goal of providing quality care. To identify factors associated with successful or unsuccessful publication of clinical trials in radiation oncology, data on trial characteristics were collected from the National Institutes of Health database on clinicaltrials.gov. To assess studies that had adequate time to accrue, trials between 2000 and 2005 were extracted by filtering for "radiation oncology". Studies were excluded if they were incomplete, observational, Phase 4, or lacked sufficient method descriptions. Included studies underwent independent samples -tests and Pearson Chi-Square bivariate analyses. 538 studies were candidates for analysis of clinical trial characteristics. United States (US) origin, multi-center sites, government funding, Phase III status, and randomized allocation were factors associated with increased publication rate. The number of study arms, study length, and number of participants were significantly greater in published trials. The review's results demonstrate potential barriers or facilitators to publication, and they suggest that publication status may be influenced by geographic, financial, and temporal characteristics of clinical trials. Understanding trial background factors that may impact publication improve data visibility and clinical advancements for all.
临床试验被视为临床研究的金标准，医学文献中寻求临床试验是为了提供高质量医疗护理这一目标。为了确定与放射肿瘤学临床试验成功或失败发表相关的因素，从美国国立卫生研究院临床试验.gov数据库收集了试验特征数据。为了评估有足够时间积累数据的研究，通过筛选“放射肿瘤学”提取了2000年至2005年期间的试验。如果研究不完整、为观察性研究、为4期研究或缺乏充分的方法描述，则将其排除。纳入的研究进行了独立样本t检验和Pearson卡方双变量分析。538项研究是分析临床试验特征的候选对象。美国来源、多中心地点、政府资助、III期状态和随机分配是与发表率增加相关的因素。发表的试验中研究组数量、研究时长和参与者数量显著更多。该综述结果表明了发表的潜在障碍或促进因素，并且表明发表状态可能受临床试验的地理、财务和时间特征影响。了解可能影响发表的试验背景因素可提高数据的可见性，并促进所有人的临床进展。
