Clinical Research Management
Study on the influencing factors of clinical trial initiation efficiency
Wang Qingqing, Miao Miao, Zhao Haijuan, Liu Fei, Yao Huiqing, Wang Tianyang, Wang Xin
Published 2022-10-21
Cite as Chin J Med Sci Res Manage, 2022, 35(5): 391-395. DOI: 10.3760/cma.j.cn113565-20211202-00189
Abstract
ObjectiveTo analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.
MethodsWe retrospectively analyzed time-cost of the review and approval of drug clinical trials initiated in Beijing Hospital from January 2020 to June 2021.The contract signing time and trial starting time of drug clinical trials in different situations were compared.
ResultsThe mean time to sign the contract in our hospital was 19(11~26) days, and the mean time to start experiment was 235(175~317) days. There was no significant difference in the contract signature time between clinical trials with different stages, different sponsors, different types of drugs and whether to be the leading site (P>0.05). Compared with other phases, phase Ⅲ drug trials took the longest time to start, and the mean initiation time of clinical trials initiated by foreign pharmaceutical companies was 136 days longer than that initiated by domestic pharmaceutical companies (P<0.05).
ConclusionsClinical trial institutions should optimize the project management process, better organize the contract review and ethics review, encourage the sponsor to use our template document. Every department may set up a GCP contact to be responsible for clinical trials; The sponsor should improve the efficiency of internal circulation and communication, submit the review materials as soon as possible according to the requirements of the institution, and establish a good communication and feedback mechanism between both sides, may shorten the start-up time of clinical trials and improve the initiation efficiency.
Key words:
Clinical trial; Inititation efficiency; Start time
Contributor Information
Wang Qingqing
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Miao Miao
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Zhao Haijuan
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Liu Fei
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Yao Huiqing
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Wang Tianyang
China Pharmaceutical University, Nanjing 211198, Jiangsu Province, China
Wang Xin
Clinical Trial Center, Beijing Hospital
National Center of Gerontology
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
