Analysis of issues and exploration of key review points in clinical trial establishment review
10.3760/cma.j.cn113565-20230922-00070
- VernacularTitle:临床试验立项审查的问题分析及审查要点探索
- Author:
Bin ZHANG
1
;
Yan LIANG
Author Information
1. 北京大学第一医院 100034
- Keywords:
Clinical trial;
Establishment review;
Review points
- From:
Chinese Journal of Medical Science Research Management
2024;37(1):27-33
- CountryChina
- Language:Chinese
-
Abstract:
Objective:As China′s new drug review and approval system continues to evolve, clinical trial management procedures are being continuously promoted and refined. This article aims to identify key review points for clinical trial establishment reviews and offer recommendations for optimizing the review process.Methods:By combining the regulatory requirements for clinical trial establishment management and the unique situation of our institution, the status of establishment approval applications upon initial submission and challenges encountered during establishment approval reviews were analyzed. The factors that may affect the likelihood of initial approval for establishment applications, and the elements and standards involved in clinical trial establishment approval reviews were studied.Results:From 2020 to 2022, the hospital received a total of 514 clinical trial establishment applications for registration purposes, with a first-time approval rate of 30.2%.Whether an application served as a team leader unit or a single-center clinical trial significantly impacted its likelihood of initial approval ( P<0.05). In clinical trial establishment reviews, drug clinical trials were most commonly associated with issues regarding sponsor qualifications, drug labeling, CRA qualifications, and drug testing reports. For medical device clinical trials, the most common issues were related to PI GCP certificate expiration dates, CRA qualifications, sponsor qualifications, and inspection reports. Conclusions:To enhance the quality and efficiency of clinical trial establishment reviews, it is recommended that trade organizations publish guidance documents on key points for clinical trial establishment reviews. Additionally, it is essential to enhance communication and collaboration among institutions, sponsors, and CROs and provide more training for relevant personnel, to jointly promote a more streamlined and effective clinical trial establishment review process.
