Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Rishikesh, Uttarakhand, India.
Department of Nursing, AIIMS, Rishikesh, Uttarakhand, India.
Indian J Pharmacol. 2021 Mar-Apr;53(2):160-169. doi: 10.4103/ijp.ijp_1090_20.
Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe.
We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software.
The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available.
At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
注册研究方案可提高透明度和可追溯性,并可估计发表偏倚的程度。在这项研究中,我们收集并呈现了全球临床研究、临床前、体外和计算机模拟研究注册中心的数据。
我们通过谷歌搜索引擎使用适当的关键词进行搜索,例如国家名称(n = 198)、大陆名称(n = 7)、注册、研究注册、动物、计算机模拟、虚拟、模拟、临床前、临床试验。使用 Medcalc 软件计算每个大陆临床研究注册和世卫组织主要注册的总体 pooled 患病率。
每个大陆的临床研究注册总体 pooled 患病率为 13%。每个大陆的世卫组织主要研究注册的患病率为 8.9%。总体而言,有 17 个与世卫组织 ICTRP 作为主要注册相关的主要注册,2 个伙伴注册,6 个注册与 ICMJE 有关联。然而,临床前动物研究注册的数量相当少(n = 4)。关于体外研究,只有国家特定的体外受精注册是可用的,然而,在其他研究领域,注册是不存在的。只有一个模拟研究注册可用。
事先进行研究注册对于处理选择性报告至关重要。研究方案和最终报告之间的比较可以让我们了解方案偏差,并评估研究结果的偏倚风险和内部有效性。尽管试验者对记录的完整性负责,但注册中心必须采取一些措施定期更新和质量控制数据。