Lotfi Samaneh, Janani Leila, Ghalichi Leila, Tanha Kiarash, Solaymani-Dodaran Masoud
Department of Epidemiology and Public Health, Iran University of Medical Sciences, Tehran, Iran.
Department of Biostatistics, Iran University of Medical Sciences, Tehran, Iran.
Med J Islam Repub Iran. 2020 Sep 8;34:116. doi: 10.34171/mjiri.34.116. eCollection 2020.
Iranian Registry of Clinical Trials (IRCT) started as a primary registry in 2008. We examined the characteristics and scientometric measures of prospectively registered clinical trials in IRCT over time and compared them with that of ClinicalTrials.gov. We selected eligible trial records between 2008 and 2016 from the IRCT database. We assessed their characteristics and the journal metrics of ensuing outputs over the study period and compared our findings with the corresponding information from ClinicalTrials.gov reported by Magdalena Zwierzyna et al. and a random sample of trials registered with this registry. We used the chi-square test for comparison of proportions and Mann-Whitney U test for comparison of medians. P-value <0.05 was considered statistically significant. Statistical analyses were performed using IBM SPSS Statistics V.22. 1751 prospectively registered clinical trials were eligible for analysis, of which 1526 (87%) had parallel-group design, 1541 (88%) reported to be randomized, 753 (43%) used double-blinding design, 485 (%27.7) had sample size more than 100, 1313 (75%) completed within a year, 1539 (87.9%) were single centered and 1529 (87.3%) exclusively used public money. Comparison with ClinicalTrials.gov showed that they are less likely to have multiple centers, funded by private sectors, continue beyond one year; and more likely to be randomized, double-blind and get published as a paper. The sample sizes were similar. Journal scientometric measures remained constant over the study period for both databases but were higher in ClinicalTrials.gov (median SJR=1.67, IQR=1.1-3.23) compared with IRCT (median SJR=0.58, IQR=0.34-0.91). Our findings suggest that clinical trials registered in IRCT are predominantly investigator-initiated studies with acceptable methodological features and high publication rate albeit in journals with substantially lower scientometric measures compared with that of ClinicalTrials.gov. Journal metric indices remained constant despite an increase in the number of registrations in IRCT.
伊朗临床试验注册中心(IRCT)于2008年作为主要注册机构成立。我们研究了IRCT中前瞻性注册临床试验随时间推移的特征和科学计量指标,并将其与ClinicalTrials.gov的相关指标进行比较。我们从IRCT数据库中选取了2008年至2016年期间符合条件的试验记录。我们评估了它们的特征以及研究期间后续产出的期刊指标,并将我们的研究结果与Magdalena Zwierzyna等人报告的ClinicalTrials.gov的相应信息以及在该注册机构注册的试验随机样本进行比较。我们使用卡方检验比较比例,使用曼-惠特尼U检验比较中位数。P值<0.05被认为具有统计学意义。使用IBM SPSS Statistics V.22进行统计分析。1751项前瞻性注册临床试验符合分析条件,其中1526项(87%)采用平行组设计,1541项(88%)报告为随机化试验,753项(43%)采用双盲设计,485项(27.7%)样本量超过100,1313项(75%)在一年内完成,1539项(87.9%)为单中心试验,1529项(87.3%)仅使用公共资金。与ClinicalTrials.gov的比较表明,它们多中心的可能性较小,由私营部门资助,持续时间超过一年的可能性较小;而随机化、双盲以及作为论文发表的可能性较大。样本量相似。两个数据库在研究期间的期刊科学计量指标保持不变,但ClinicalTrials.gov的指标高于IRCT(SJR中位数=1.67,IQR=1.1 - 3.23),而IRCT的指标为(SJR中位数=0.58,IQR=0.34 - 0.91)。我们的研究结果表明,在IRCT注册的临床试验主要是研究者发起的研究,具有可接受的方法学特征和较高的发表率,尽管与ClinicalTrials.gov相比,发表期刊的科学计量指标要低得多。尽管IRCT的注册数量有所增加,但期刊指标指数保持不变。