Study on the influencing factors of clinical trial initiation efficiency
10.3760/cma.j.cn113565-20211202-00189
- VernacularTitle:临床试验启动效率的影响因素研究
- Author:
Qingqing WANG
1
;
Miao MIAO
;
Haijuan ZHAO
;
Fei LIU
;
Huiqing YAO
;
Tianyang WANG
;
Xin WANG
Author Information
1. 北京医院临床试验研究中心 国家老年医学中心 中国医学科学院老年医学研究院，北京 100730
- Keywords:
Clinical trial;
Inititation efficiency;
Start time
- From:
Chinese Journal of Medical Science Research Management
2022;35(5):391-395
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.Methods:We 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.Results:The 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). Conclusions:Clinical 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.
