中国临床试验注册中心口腔类临床研究注册项目的特征分析

Characteristics analysis of oral clinical trials registered in Chinese Clinical Trial Registry

目的调查注册于中国临床试验注册中心(Chinese Clinical Trial Registry,ChiCTR)的口腔类临床研究项目的特征及开展情况,为医疗机构开展口腔类临床研究及管理制度的制订提供参考。方法检索ChiCTR数据库,搜集所有口腔相关临床研究,检索时间从ChiCTR建库至2021年7月25日,对检索时间内的口腔医学类临床研究注册题目、注册时间、注册状态、地域分布、伦理委员会批准情况、样本量、经费来源、疾病类型、研究类型及设计、随机化方法、是否采用盲法等信息进行统计分析。结果ChiCTR已注册的口腔类临床研究共778项,研究的疾病主要为口腔颌面疾病、牙周组织疾病、口腔种植疾病、口腔黏膜疾病、口腔修复疾病。参与实施口腔临床研究的机构主要分布于北京、四川、上海、广东、湖北,占所有参与实施机构的69.68%(772/1108)。标注经费来源的717项研究共获得746项经费资助,其中前4位分别为医院资助[24.93%(186/746)]、地方财政[22.39%(167/746)]、自筹经费[17.69%(132/746)]、国家财政[12.47%(93/746)]。研究类型主要为干预性研究[66.84%(520/778)]和观察性研究[31.36%(244/778)]。研究设计以随机对照试验为主[48.97%(381/778)],其中半数以上的研究[62.99%(240/381)]在盲法部分填写缺失或未说明盲法。结论口腔类临床研究呈逐年递增趋势,但存在地区不均衡性,且临床研究注册信息、研究设计等质量方面尚有待提高。各级管理部门应加大对临床试验注册和发表机制的宣教力度,提高研究者对临床研究注册、临床研究设计的重视。

Objective To investigate the project characteristics of oral clinical trials registered in Chinese Clinical Trial Registry(ChiCTR),and to provide reference for medical institutions to improve the quality of oral clinical trials and formulate management systems.Methods The ChiCTR database was retrieved to collect all the oral-related clinical trials from the time of database establishment to July 25,2021.Those clinical trials were analyzed statistically in respect of name of registered project,registration time,registration status,regional distribution of research institutions,approval status by ethics committee,sample size,source of funds,involved disease,research type and design,randomization method,and whether blind method was adopted.Results A total of 778 oral clinical trials,which studied mainly in the oral and maxillofacial diseases,periodontal tissue diseases,oral implant diseases,oral mucosal diseases,and oral prosthetic diseases,were retrieved in the database.Beijing,Sichuan,Shanghai,Guangdong and Hubei were major regions where oral clinical trials were carried out,accounting for 69.68%(772/1108)of the total.The top four funding sources were hospital finance[24.93%(186/746)],local government finance[22.39%(167/746)],self-financing[17.69%(132/746)],and national finance[12.47%(93/746)].For the types of researches,520 interventional studies and 244 observational studies were identified(accounting for 66.84% and 31.36%,respectively).The research designs were dominated by ways of randomized control(381,48.97%),of which 240(62.99%)trials were with missing or unspecified blinding methods.Conclusions Oral clinical trials are increasing year by year,but they are regionally imbalanced,and still need to be further improved in registration information and research design.Administrative departments should pay more attention to strengthen the publicity and education on the registration and publication mechanism of clinical trials,and enhance researchers′cognitions in clinical trials registration and clinical trials design.