摘要
目的分析药物临床试验的受试者筛选失败分布情况,探讨提高筛选受试者成功率的策略,为研究机构、申办方制订受试者招募计划提供参考依据。方法查阅贵州医科大学附属医院2013年1月～2016年10月承接药物临床试验项目筛选资料,并与临床试验研究团队及受试者面谈。采用SPSS 19.0统计软件进行数据统计。结果收集到47项药物临床试验的筛选资料,共筛选958名受试者,筛选失败182名,筛选失败率为19.00%。其中,受试者因体检结果不符合入选标准或符合排除标准占29.67%(54名);撤回知情同意书占26.37%(48名);导入失败占21.98%(40名);实验室指标符合排除标准或不符合入选标准占19.23%(35名);其他原因占2.75%(5名)。有导入期项目中导入失败数占筛选总数的18.52%(40/216)。结论受试者体检结果不符合方案要求与受试者撤回知情同意书是受试者筛选失败的主要原因;在有导入期的试验项目中,存在较高的导入失败风险。制订科学可行的试验方案,拟定合理可行的招募计划招募合适的人群,充分培训研究者,使研究者在筛选前与受试者有效沟通,使受试者较细致地了解临床试验知识,研究者获取更多关于受试者的信息,有助于提高临床试验筛选成功率。
Objective To analyze the main reasons of the screening failure, explore the strategies for improving the success rate of screening, in order to provide the reference frame for research institute and sponsor making recruitment plan. Methods From January 2013 to October 2016, in Affiliated Hospital of Guizhou Medical University, the data of drug clinical trial program were selected, the clinical trial research teams and subjects were given interview. The data statistics described by SPSS 19.0 statistical software. Results There were 47 drug clinical trials were involved, 958 subjects were screened, and 182 of them were screening failed. 54 subjects (29.67%) were physical examination results did not meet the inclusion criteria or met exclusion criteria;48 subjects (26.37%) withdrew informed consent forms before enrolling;40 subjects (21.98%) failed during run-in period;35 subjects (19.23%) were laboratory indicators met the exclusion criteria or did not meet the inclusion criteria;5 subjects (2.75%) were screening failed for other reasons. Conclusion The main reasons for failure of subjects screening are that the physical examination results do not meet the requirements of the drug clinical trials and the withdrawing of the informed consent forms. If a run-in period is designed in a clinical trial, there is a higher risk of screening failure in the run-in period. Formulating scientific and feasible screening scheme, drawing up reasonable and feasible recruitment plan, more training investigators, increasing knowledge popularization of clinical trials, they are all helpful for recruitment and improving the success rate of screening in drug clinical trials.
作者
刘琳
何艳
周岩
李娜
曾艳
张倩
LIU Lin;HE Yan;ZHOU Yan;LI Na;ZENG Yan;ZHANG Qian(Drug Clinical Trials Office, Affiliated Hospital of Guizhou Medical University, Guizhou Province, Guiyang 550001, China)
出处
《中国医药导报》
CAS
2019年第6期177-180,共4页
China Medical Herald
基金
贵州省贵阳市科技计划项目(筑科合同[20151001]号)
关键词
药物临床试验
受试者
招募
筛选
原因分析
Drug clinical trials
Subjects
Recruitment
Screening
Cause analysis
作者简介
刘琳(1987.11-),女,硕士,主要从事药物临床试验管理、数据管理及统计分析工作;通讯作者:何艳(1972.9-),女,博士,主任医师,教授,硕士研究生导师,贵州医科大学附属医院科研处副处长、药物临床试验机构办公室主任,主要从事药物临床试验管理工作.
