摘要/Abstract

摘要： 目的 ·分析注册于中国临床试验注册中心（ ChiCTR）的放射治疗（放疗）临床试验的特征。方法 ·检索自 ChiCTR成立至 2018年 12月 1日的放疗临床试验，记录并分析特征。结果 · ChiCTR累计注册放疗临床试验 274项，项目数逐年上升。其中 79.9%为预注册， 51.5%的征募状态为正在进行， 27.4%有数据管理委员会。肺癌、鼻咽癌、肝癌、食管癌为前 4位研究癌种。 53.7%开展于北京、上海、广东和四川。 86.4%为单中心研究。 69.7%的经费来源为个人或单位自筹。 40.5%着力于初期探索新的放疗方案。研究类型主要为干预性研究（ 50.7%）和观察性研究（ 39.8%）。企业资助的项目更倾向于较大样本量和采用随机化分组，自筹项目更倾向于采用盲法（均 P<0.05）。结论 ·中国放疗临床试验整体较为规范，但地域分布不均衡，研究规模偏小，存在注册信息填写错误及不全的情况。
关键词: 放射治疗, 临床试验, 特征
Abstract:
Objective · To analyze the characteristics of radiotherapy clinical trials registered in Chinese Clinical Trials Registry (ChiCTR). Methods · The radiotherapy clinical trials registered in ChiCTR before December 1, 2018 were retrieved. Their characteristics were recorded and analyzed. Results · A total of 274 registered radiotherapy clinical trials were in ChiCTR, and the number increasedyear, in which 79.9% were preregistered, 51.5% were ongoing, and 27.4% had data monitoring committees. The top four researched diseases were lung cancer, nasopharyngeal cancer, liver cancer and esophageal cancer. 53.7% were conducted in Beijing, Shanghai, Guangdong and Sichuan. 86.4% were single-center. 69.7% were fundedindividuals or units. 40.5% focused on new radiotherapy schemes. The main types of research were intervention study (50.7%) and observational study (39.8%). Enterprise-funded projects tended to larger sample size and randomization, while self-funded projects tended to blinding (all P<0.05). Conclusion · Radiotherapy clinical trials in China are relatively standardized, but the regional distribution is unbalanced, the scale of research is small, and some registration information is incorrect or incomplete.
Key words: radiotherapy, clinical trials, characteristics


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