Analysis of issues and exploration of key review points in clinical trial establishment review
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目的 在我国新药审评审批制度持续改革的推动下，临床试验各项管理流程在持续改进和完善。本文旨在探索临床试验机构对临床试验立项的审查要点，为进一步优化立项审查标准提供建议。 方法 本文通过梳理临床试验立项管理的法规要求，结合医院情况，分析立项申请一次审核通过情况及立项审查中发现的问题，探索可能影响立项申请一次审核通过的因素及临床试验立项审查要素和标准。 结果 2020—2022年，医院共受理了514项以注册为目的的临床试验项目立项申请，一次审核通过的百分比为30.2%。是否作为组长单位和单中心临床试验是立项申请一次审核通过的影响因素(P<0.05)。在立项审查中，药物临床试验的问题位居前几位的分别是申办者资质，药物标签，监查员资质和药检报告等；医疗器械临床试验的问题位居前几位的分别是PI的GCP证书时限，监查员资质，申办者资质和检验报告等。 结论 建议行业内部出台临床试验立项审查要点指导性文件，加强机构与申办者及CRO的沟通交流，加强对相关人员的培训，从而共同促进临床试验立项审查的质量和效率。 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.
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.
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