摘要
目的分析前列腺癌药物临床试验老年受试者样本是否具有代表性。方法从试验设计层面上,查询药物临床试验登记和信息公示平台上公示的2019年1月至2021年12月针对以老年患者为主的前列腺癌药物临床试验对受试者年龄的规定;从实际入组层面上,收集某医院自2010年1月至2022年6月立项并完成受试者入组的前列腺癌药物临床试验,已出具总结报告的多中心试验采集全部中心的受试者年龄信息,未出具总结报告的或单中心试验采集本中心受试者年龄数据与中国肿瘤登记系统中前列腺癌平均发病年龄、分年龄段发病率进行比较,比较二者是否一致。结果绝大多数(72.1%、44/61)临床试验在方案设计层面上未设置年龄上限,Ⅲ期、Ⅳ期试验均未在方案中设置入组受试者年龄上限。从实际入组层面,本研究共纳入19项药物临床试验,1402例受试者,受试者年龄60~93(67.1±8.6)岁,与全国及北京市前列腺癌发病平均年龄差异有统计学意义(均P<0.001),入组人数最多的年龄段为60~64岁(34.2%、479/1402)、≥75岁最少(21.5%、301/1402),年龄分布与2017年中国前列腺癌高发年龄段≥75岁(421.77/10万)不同。结论前列腺癌药物临床试验在设计方面涵盖全年龄段老年患者,但实际入组的老年受试者样本代表性不足,在保护受试者安全的前提下,与前列腺癌平均发病年龄、分年龄段发病率相匹配的受试人群应该逐步提升。
Objective To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods From the level of trial design,the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level,the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report,and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System,so as to compare whether the two were consistent.Results Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.PhaseⅢand phaseⅣtrials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level,a total of 19 studies were included in this study,with 1402 subjects,and the average age of subjects was 67.1±8.6 years old,which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001).The age group with the largest number of participants was 60-64 years old(34.2%、479/1402).The population aged≥75 years was the least(21.5%,301/1402),which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100000).Conclusions Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients,but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects,the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups,should be gradually increased.
作者
姚慧卿
赵海娟
苗苗
王情情
刘飞
赵朗
刘瑶
张莹
王欣
Yao Huiqing;Zhao Haijuan;Miao Miao;Wang Qingqing;Liu Fei;Zhao Lang;Liu Yao;Zhang Ying;Wang Xin(Clinical Trial Center,Beijing Hospital,National Center of Gerontology Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)
出处
《中华老年医学杂志》
CAS
CSCD
北大核心
2022年第10期1197-1201,共5页
Chinese Journal of Geriatrics
基金
首都卫生科研发展专项(2022-2Z-4055)
中国医学科学院医学与健康科技创新工程(2021-I2M-1-045)
中央高校基本科研业务费专项资金资助(3332021080)。
关键词
前列腺肿瘤
药物
临床试用
发病年龄
Prostatic neoplasms
Drugs,investigational
Age of onset
