临床试验注册号

为了增加临床试验信息的透明度,提高临床医学研究的质量及公众信任度,世界卫生组织于2004年开始积极倡导并大力推行临床试验注册制度。中医药期刊鼓励优先发表经注册的临床试验报告。临床试验注册号应是从世界卫生组织认证的一级临床试验注册中心获得的全球唯一的注册号。临床试验注册号以“临床试验注册”为标志,标明注册机构名称和注册号。     

临床试验注册号

<正>为了增加临床试验信息的透明度,提高临床医学研究的质量及公众信任度,世界卫生组织于2004年开始积极倡导并大力推行临床试验注册制度。中医药期刊鼓励优先发表经注册的临床试验报告。临床试验注册号应是从世界卫生组织认证的一级临床试验注册中心获得的全球唯一的注册号。临床试验注册号以"临床试验注册"为标志,标明注册机构名称和注册号。     

临床试验注册号

<正>为了增加临床试验信息的透明度,提高临床医学研究的质量及公众信任度,世界卫生组织于2004年开始积极倡导并大力推行临床试验注册制度。中医药期刊鼓励优先发表经注册的临床试验报告。临床试验注册号应是从世界卫生组织认证的一级临床试验注册中心获得的全球唯一的注册号。临床试验注册号以"临床试验注册"为标志,标明注册机构名称和注册号。     

全科医生小词典——临床试验注册

临床试验注册指在公开的临床试验注册机构登记足以反映该试验进展的重要研究和管理信息,并向公众开放,以实现临床试验设计和实施的透明化。任何人均可通过互联网免费查询和评价自己感兴趣的研究。WHO认为:临床试验注册具有伦理和科学的意义。此外,临床试验注册不仅能确保追溯每     

关于本刊加入中国临床试验注册与发表协作网的申明

临床试验注册指所有涉及人体的试验在世界卫生组织一级注册机构登记注册,将研究者、研究实施单位、研究目的、干预措施等试验信息公之于众,这是提高医学试验公信度、提高临床试验质量的有效措施。     

国内中医药防治肺癌临床试验注册现况分析

[目的]通过分析中国临床试验注册中心（ChiCTR）注册内与中医药防治肺癌相关的临床试验,探讨其注册特点及发展趋势。[方法]计算机检索ChiCTR数据库从建库至2021年12月31日中医药防治肺癌相关的临床试验。对检索到临床试验进行查重并提取相关数据。应用SPSS 26.0软件对纳入研究数据进行统计分析,并归纳临床试验特征。[结果]共纳入中医药防治肺癌临床试验94项,其中预注册85项;临床试验注册单位分布在中国17个省级行政区,40家临床注册机构。临床试验注册排名前3位的地区分别为：北京市、上海市、广东省;经费来源位居前3位依次为：地方财政24项（25.53%）、国家财政17项（18.06%）、自筹经费14项（14.89%）;研究类型以干预性研究为主,仅有17项研究使用盲法。[结论]中国中医药防治肺癌临床试验注册数量总体呈现上升趋势,研究者临床注册意识显著提高,但试验设计及规范性欠佳,且试验注册存在明显地域分布不均衡,倡导研究者加强临床试验注册规范化,建议管理部门建立更完善的注册审核制度,以期未来能更进一步发挥中医药防治肺癌的优势。     

中国临床试验注册中心公告

中国临床试验注册中心(Chinese Clinical Trial Register,ChiCTR)为卫生部支持的国家临床试验注册中心,世界卫生组织国际临床试验注册协作网一级注册机构(World Health Or-ganization International Clinical Trial Registration Platform PrimaryRegister,WHO ICTRP Primary R     

中国临床试验注册中心公告

中国临床试验注册中心（Chinese Clinical Trial Register，ChiCTR）为卫生部支持的国家临床试验注册中心，世界卫生组织国际临床试验注册协作网一级注册机构（World Health Organization International Clinical Trial Registration Platform Primary Register，WHOICTRP Primary Register），     

中国临床试验注册中心公告

中国临床试验注册中心 （ Chinese Clinical Trial Register, ChiCTR）为卫生部支持的国家临床试验注册中心,世界卫生组织国际临床试验注册协作网一级注册机构 （ World Health Organization International Clinical Trial Registration Platform Primary Register, WHO ICTRP Primary Register）,由四川大学华西医院卫生部中国循证医学中心于2005年10月组建,2007年7月25日正式运行。全球临床试验注册制度由世界各国政府共同决定由WHO领导建立。临床试验注册具有伦理和科学的意义,     

基于ClinicalTrials.gov的医学人工智能临床试验注册现状分析

目的:分析医学人工智能临床试验注册现状,为医学人工智能临床转化研究提供参考和证据支持。方法:通过ClinicalTrials.gov注册平台对医学人工智能临床试验数据进行采集、分析,采用文献计量学及对比研究的方法,从注册数量、研究类型、分期、适应证和申办者等角度进行医学人工智能临床试验注册现状研究。结果与结论:全球医学人工智能临床试验共649项,中国50项,位列全球第二位,但与美国尚存在较大差距;全球医学人工智能随机对照试验295项,中国12项;国际多中心临床试验32项,中国大陆未见参与;全球医学人工智能临床试验处于Ⅱ期的数量最多;全球医学人工智能临床试验适应证主要集中于疾病监测或健康管理、医学影像辅助诊断、疾病预测和治疗等,中国主要集中于诸如眼病筛查、肿瘤诊断等医学影像辅助诊断;全球医学人工智能临床试验的申办者共422个,中国29个,注册数量前15位申办者中大多为研究机构和医疗机构。     

中国MSC临床试验注册阶段性特征调查分析

目的 基于中国临床试验注册中心平台，分析探讨间充质干细胞（mesenchymal stem cell，MSC）临床试验研究在我国的特点及发展趋势。方法 通过在中国临床试验注册中心数据库进行检索，将2007年建库起至2022年4月的所有与MSC相关的临床试验项目纳入统计，对项目名称、研究所涉疾病/系统、研究所处阶段、注册时间、注册状态、研究负责单位地域分布等信息进行整理分析。结果 共有197项MSC相关临床试验纳入统计，注册数量整体呈逐年增加趋势；注册地集中在北京、上海、广东等地；经费以医院资助、地方财政、国家财政资金为主；项目研究以脐带为间充质干细胞主要来源，共涉及11个类别的系统相关疾病。结论 现阶段，MSC临床试验数目呈递增趋势，但存在地区间的不均衡性；我国干细胞研究者的临床试验注册观念正逐步建立，且已意识到临床注册的重要性，未来将持续促进MSC治疗的规范化和临床应用转化。     

我国COVID-19相关临床试验注册特点及存在的伦理学问题

目的：通过对我国新型冠状病毒感染(COVID-19)相关临床试验注册信息多角度分析,探讨其中存在的伦理学问题,以期为新突发传染病等公共卫生事件临床伦理的规范化提供依据。方法：在美国临床试验注册中心(ClinicalTrials.gov)和中国临床试验注册中心(ChiCTR)使用“新型冠状病毒”“COVID-19”等关键词检索2020年1月1日至2022年11月15日注册的COVID-19相关临床试验,归纳分析其注册的时空分布特点、研究类型、干预措施、研究状态及伦理等信息,发现并探讨相关伦理学问题。结果：共纳入1 560项COVID-19相关的临床试验,其中ClinicalTrials.gov注册481项,ChiCTR注册1 079项。临床试验注册高峰期集中在2020年2-4月;根据省级行政区划分湖北省、上海市、北京市临床试验注册量较多。干预性研究(843/1 560,54.00%)在所有注册类型中占比最高,注册内容涉及疫苗(202/843,23.96%)、化学药品(193/843,22.89%)、中医药(153/843,18.15%)及生物制品(90/843,10.68%)等多个方面;...     

Swedish guidelines for registry-based randomized clinical trials

Abstract

During the last decade Sweden has invested in a national infrastructure for collection of structured clinical data in the form of healthcare registries (in Sweden known as Kvalitetsregister). These data can be combined with other public data using the national personal identifiers that are issued to Swedish citizens. The healthcare registries have an almost complete coverage of Swedish healthcare, and a large network of clinicians is involved in the quality assurance and continuous improvement of healthcare using these registries. Uppsala Clinical Research Center (UCR) has been a technology provider of large-scale national registries and has a strong background in clinical trial management. This effort combines the areas of healthcare registries and clinical trials into a novel way of performing clinical trials to be able to: 1) run clinical trials as an integrated part of normal clinic workflow; and 2) leverage the nationwide network of outcome reporting. This strategy was shown to be successful in the TASTE (Thrombus Aspiration in Myocardial Infarction) study. When TASTE had been published, the New England Journal of Medicine wrote a perspective on the study calling it ‘The randomized registry trial—the next disruptive technology in clinical research?’ Since then several studies have been conducted in this way with great success. UCR has been appointed, by Clinical Studies Sweden and the Swedish Research Council, to develop the Swedish national guidelines for registry-based randomized clinical trials in order to ensure the possibility for more organizations to run this kind of study. This paper describes key concepts of register-based randomized clinical trials and the development of Swedish national guidelines.     

基于WHO国际临床试验注册平台重症哮喘临床试验注册现状分析

背景　重症哮喘临床控制较差,且欠缺有效的治疗方法,故亟需更多相关临床研究;临床注册试验可为临床防治工作奠定基础,而目前重症哮喘临床注册现状尚不清楚,尚不能为临床试验提供新视角。目的　基于WHO国际临床试验注册平台（ICTRP）数据,了解重症哮喘临床试验注册特点。方法　计算机检索WHO ICTRP数据库,搜集建库起至2019-12-15注册的重症哮喘相关临床试验资料。由2名研究者独立筛选文献、提取资料后,对纳入试验进行描述性分析。结果　共检索到重症哮喘相关临床试验235个,临床试验注册数量自建库起逐年上升,近4年有下降趋势。试验申请国家分布不均,重症哮喘患病率较高国家试验申请极少。各注册中心试验大多来自本国家。资金主要来源于单位和企业。研究病种以重症哮喘为主（89.36%）,涉及年龄以成人为主（90.64%）。试验类型以干预性为主（65.96%）,干预性试验中随机试验占67.10%,仅9个试验描述其采用的随机方法;观察性研究中以队列研究居多（38.75%）;44.26%的试验未注明盲法情况,其余试验双盲占据较多（25.53%）;试验分期以N/A（32.77%）、Ⅲ期试验（20.00%）最多。干预措施以药物干预为主（77.42%）。结局指标以肺功能、哮喘加重情况、生存质量评价为主。结论　重症哮喘临床试验近几年呈下降趋势,试验申请国家分布不均,研究病种以重症哮喘为主,研究类型以干预性为主,干预措施多为西药干预。     

我国临床试验机构合作情况研究

基于在美国临床试验注册网站注册的国内多机构合作临床试验数据,利用SPSS统计软件、Gephi可视化社会网络分析软件对在我国开展的临床试验的主要特点和机构合作情况进行分析,识别合作频繁的机构及其合作模式,提出应加快促进我国临床研究发展、加强临床试验数据管理和利用。     

国内癌因性疲劳中医药相关临床试验注册现状分析

目的 通过分析中国临床试验注册中心(Chinese clinical trial registry，ChiCTR)注册的与中医药干预癌因性疲劳(cancer-related fatigue，CRF)相关的临床试验，探讨其试验注册现状。方法 检索ChiCTR数据库收录的从建库至2022年6月2日与中医药相关的CRF临床研究注册试验，对检索结果进行筛选并提取所需数据信息，运用WPS Office软件的表格功能对纳入研究数据进行统计分析，并归纳临床试验特征。结果 最终纳入36项CRF中医药相关临床试验，覆盖全国6个省、3个直辖市，其中包括干预性研究34项，观察性研究2项，招募样本量5 327例，干预措施包括内服药物疗法、中药注射液、外治法和中医传统功法。结论 目前有关CRF中医药临床试验注册数量总体呈上升趋势，试验以随机对照试验(randomized controlled trial, RCT)研究居多，干预性研究为主，其空间分布欠均衡，且注册信息的严谨性与结局指标的规范性待进一步提高。     

Registering clinical trials in India: a scientific and ethical imperative

The Clinical Trials Registery-India is an online, primary register of the WHO's International Clinical Trials Registry Platform. It was launched on 20 July 2007, and is now open to the prospective registration of clinical trials of any intervention conducted in India involving human participants. Registration is voluntary and free, and the register is searchable free of charge. Public disclosure of all 20 items in the WHO Trial Registration Data Set is mandatory for a valid registration number to be allocated. This number is required if the results are to be published in journals that endorse the International Committee of Medical Journal Editors' position on prospective trials registration. Trials in the Clinical Trials Registery-India will be included in the central repository of the WHO's International Clinical Trials Registry Platform search portal. In addition to the 20 items, the Clinical Trials Registery-India also requires mandatory disclosure of details of ethics committee and regulatory clearances. Further items pertaining to the methods that improve the internal validity of the trial are optional and serve as a template to improve trial design and the reliability of results. The success of this endeavour depends on the cooperation of the pharmaceutical industry, academic institutions, medical associations, ethics committees and medical journal editors in India. In the absence of legislation, ethics committees and medical journal editors have an important role in ensuring prospective registration of trials.     

COVID-19 trial graph: a linked graph for COVID-19 clinical trials

ObjectiveClinical trials are an essential part of the effort to find safe and effective prevention and treatment for COVID-19. Given the rapid growth of COVID-19 clinical trials, there is an urgent need for a better clinical trial information retrieval tool that supports searching by specifying criteria, including both eligibility criteria and structured trial information.Materials and MethodsWe built a linked graph for registered COVID-19 clinical trials: the COVID-19 Trial Graph, to facilitate retrieval of clinical trials. Natural language processing tools were leveraged to extract and normalize the clinical trial information from both their eligibility criteria free texts and structured information from ClinicalTrials.gov. We linked the extracted data using the COVID-19 Trial Graph and imported it to a graph database, which supports both querying and visualization. We evaluated trial graph using case queries and graph embedding.ResultsThe graph currently (as of October 5, 2020) contains 3392 registered COVID-19 clinical trials, with 17 480 nodes and 65 236 relationships. Manual evaluation of case queries found high precision and recall scores on retrieving relevant clinical trials searching from both eligibility criteria and trial-structured information. We observed clustering in clinical trials via graph embedding, which also showed superiority over the baseline (0.870 vs 0.820) in evaluating whether a trial can complete its recruitment successfully.ConclusionsThe COVID-19 Trial Graph is a novel representation of clinical trials that allows diverse search queries and provides a graph-based visualization of COVID-19 clinical trials. High-dimensional vectors mapped by graph embedding for clinical trials would be potentially beneficial for many downstream applications, such as trial end recruitment status prediction and trial similarity comparison. Our methodology also is generalizable to other clinical trials.     

医学研究登记备案信息系统设计与应用

基于《干细胞临床研究管理办法(试行)》的要求,全国获准从事干细胞研究的机构均在医学研究登记备案信息系统上进行机构登记注册,全国各级医院所进行的临床研究,均应进行注册并公告。详细介绍医学研究登记备案信息系统的架构及功能,并与国际上相似功能的注册登记系统进行比较。     

Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review

ObjectiveReal-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes.Materials and MethodsQuerying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions.ResultsOf 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values.DiscussionDatabase-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use.ConclusionEnhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.