精神科医生推荐药物临床试验的意愿与影响因素  

The attitudes and influencing factors of psychiatrists regarding drug clinical trials

作　　者：杜岚婷 宓为峰[1] 周书喆 付艺[1] 郝晓楠[1] 李玲芝[1] 郭丽华[1] 施莹[1] 张鸿燕[1] DU Lan-ting;MI Wei-feng;ZHOU Shu-zhe;FU Yi;HAO Xiao-nan;LI Ling-zhi;GUO Li-Hua;SHI Ying;ZHANG Hong-yan(Office of Good Clinical Practice,Peking University Sixth Hospital,Peking University Institute of Mental Health,Key Laboratory of Mental Health,Ministry of Health,Beijing 100191,China)

机构地区：[1]北京大学第六医院,北京大学精神卫生研究所,国家卫生健康委员会精神卫生学重点实验室,国家精神心理疾病临床医学研究中心,北京100191

出　　处：《中国临床药理学杂志》2021年第16期2236-2237,2241,共3页The Chinese Journal of Clinical Pharmacology

基　　金：“重大新药创制”科技重大专项基金资助项目(2018ZX09734005);首都特色基金资助项目(Z181100001718157)。

摘　　要：目的本研究将探索精神科医生对药物临床试验的推荐意愿及影响因素,改善药物临床试验的招募工作。方法本研究为非干预性、多中心、横断面问卷调查,在10家精神科专科或医院精神科进行。结果共回收问卷318份,其中有效问卷317份。精神科医生中,会推荐适合患者参加临床试验的有284例(91.32%)。推荐患者参加的原因为促进新药研发及医学发展(推荐9.54%,不知道是否推荐60.00%)。不推荐的原因为对新药的副作用了解不足(不推荐12.50%,不知道是否推荐83.33%)。讨论绝大部分精神科医生愿意推荐符合入组条件的患者参加药物临床试验。精神科医生及时了解临床试验最新相关信息,拓宽医生获取临床试验信息的渠道,明确医生在药物临床试验中所扮演的角色,可能会改善对药物临床试验的招募。Objective This study was aimed at the attitudes and influencing factors of psychiatrists regarding drug clinical trials.Methods This noninterventional,multicenter and crosssectional study was conducted in 10 psychiatric specialties or hospitals in South of Yangtze River,Northeast and West of China,and Northern China.Results A total of questionnaires was 318,of which 317 were qualified.284 of psychiatrists(91.32%)were willing to recommend proper patients to participate in drug clinical trials.The reason for recommendation was promoting new drug and medicine development(recommend 9.54%,don’t know 60.00%).The reason why psychiatrists wouldn’t recommend was that they didn’t know potential adverse effects of new drug very well(not recommend 12.50%,don’t know 83.33%).Discussion Psychiatrists needed to know more about drug clinical trials,be clear about the role of themselves in drug clinical trials,and establish harmonious doctorpatient relationship,which might facilitate the enrollment.

关 键 词：药物临床试验 精神科医生 推荐意愿 影响因素 

分 类 号：R95[医药卫生—药学]