Analysis on Time-consuming of Multi-center Drug Clinical Trial Project from Approval to Start-up
10.13748/j.cnki.issn1007-7693.20222738
- VernacularTitle:多中心药物临床试验项目立项至启动耗时分析
- Author:
LI Qingzhao
1
,
2
;
SHI Lingdong
1
,
2
;
LIANG Xiao
1
,
2
;
HUANG Hao
1
,
2
;
XIE Xueping
1
,
2
;
LIANG Lili
1
,
2
;
ZHONG Hui
1
,
2
Author Information
1. The First People'
2. s Hospital of Nanning, Nanning 530022, China
- Publication Type:Journal Article
- Keywords:
multi-center drug clinical trial;
approval;
start-up;
review efficiency;
contract template
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(13):1869-1873
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To explore how to shorten the time from approval to start-up of drug clinical trial project. METHODS Twenty-two phase Ⅱ-Ⅲ multi-center drug clinical trial projects start up in The First People's Hospital of Nanning from 2020 to 2021 were selected. The time-consuming of each link before the launch was analyzed, and the time- consuming of project approval, ethical review and contract review between the sponsor and research institution was compared, as well as the influence of using the contract template of each party on the time-consuming of contract review was compared. RESULTS Contract review took the longest time. There was no significant difference in the time-consuming between the sponsor and the research institutions in the three links of project approval, ethical review and contract review. Used the contract template of the research institutions, the time spent by the sponsor and the research institution in the review process, as well as the contract signing time of the project were shorter. CONCLUSION Using the clinical trial management system, conduct differentiated ethical review methods, advance drug delivery and commitment letter submission, use the contract template of research institutions or sign a framework contracts, establish a effective communication methods are all effective ways to reduce the time taken before start-up.
