Common problems and suggestions of biological sample management in drug clinical trials

XIE Jiangchuan; XIE Linli; MA Pan; PAN Xinmei; CAO Liya; ZHANG Xin; CHEN Yongchuan

doi:10.6039/j.issn.1001-0408.2024.05.03

您当前的位置：

首页 >

文章列表页 >

Common problems and suggestions of biological sample management in drug clinical trials

更新时间：2024-03-08

- Common problems and suggestions of biological sample management in drug clinical trials
- ZHONGGUO YAOFANG Vol. 35, Issue 5, Pages: 524-528(2024)
- 作者机构：
  
  陆军军医大学第一附属医院药学部，重庆　400038
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.05.03
  CLC： R951
- Published：15 March 2024，
  
  Received：14 December 2023，
  
  Revised：22 January 2024，
扫描看全文
谢江川,谢林利,马攀等.药物临床试验中生物样本管理常见问题及措施建议 ^Δ[J].中国药房,2024,35(05):524-528.

XIE Jiangchuan,XIE Linli,MA Pan,et al.Common problems and suggestions of biological sample management in drug clinical trials[J].ZHONGGUO YAOFANG,2024,35(05):524-528.
谢江川,谢林利,马攀等.药物临床试验中生物样本管理常见问题及措施建议 ^Δ[J].中国药房,2024,35(05):524-528. DOI： 10.6039/j.issn.1001-0408.2024.05.03.

XIE Jiangchuan,XIE Linli,MA Pan,et al.Common problems and suggestions of biological sample management in drug clinical trials[J].ZHONGGUO YAOFANG,2024,35(05):524-528. DOI： 10.6039/j.issn.1001-0408.2024.05.03.

摘要

目的

为完善药物临床试验生物样本管理相关标准操作规程（SOP）及生物样本的管理提供参考。

方法

以《药物临床试验质量管理规范》《药物临床试验数据现场核查要点》《人类遗传资源管理条例实施细则》《药物临床试验机构资格认定检查细则》为参照，根据笔者临床试验项目的管理经验，通过统计质控表、申办方上报的方案偏离（PD），对2016年7月－2023年5月笔者负责管理的药物临床试验项目在生物样本管理方面出现的不规范操作进行分析，并提出生物样本规范化管理的建议。结果与

结论

纳入了60项药物临床试验项目，共发现生物样本管理相关不规范项101条。生物样本采集、保存、处理为生物样本管理不规范操作发生率最高的环节，不规范项条数分别占总条数的37.62%、25.74%、21.78%。规范生物样本的管理需多方努力，比如机构办及伦理委员会在项目立项时对试验方案、知情同意书、遗传办申请书中涉及生物样本采集及处理的一致性等进行仔细审核，项目启动时机构办质控员应关注授权的人员是否出席并参加培训，项目开展阶段主要研究者、研究护士、采集人员、处理人员、运送人员、中心实验室相关人员、机构办质控员是否各司其职。在此基础上，生物样本管理各参与方应做好有效沟通，发现问题及时上报，并针对关键环节进行专项学习。

Abstract

OBJECTIVE

To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials.

METHODS

According to

Good Clinical Practice

，

Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution

， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward.

RESULTS &

CONCLUSIONS

A total of 101 biospecimen-related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.

关键词

药物临床试验生物样本生物样本管理

Keywords

biological samplebiological sample management

references

黄国宁，叶嘉俊，陈丽丽，等.临床试验方案与知情同意书中生物样本检测后处理情况分析[J].医药导报，2022，41（10）：1553-1556.

HUANG G N，YE J J，CHEN L L，et al. Analysis and consideration of processing biological samples after testing in clinical trial protocol and informed consent form[J]. Her Med，2022，41（10）：1553-1556.

寇莹莹，赵敏，李苗.临床试验生物样本全流程管理模式构建[J]. 中国食品药品监管，2019（12）：58-60.

KOU Y Y，ZHAO M，LI M. Construction of whole process management model for biological samples in clinical trials[J]. China Food Drug Adm Mag，2019（12）：58-60.

国家药品监督管理局.药物临床试验质量管理规范：2020局令第57号[EB/OL].[2023-12-14].https：//www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/2020042616- 2401243.htmlhttps://www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/2020042616-2401243.html.

National Medical Products Administration. Good clinical practice for drug trial quality management：order No.57 of 2020[EB/OL].[2023-12-14].https：//www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/2020042616-2401243.htmlhttps://www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/2020042616-2401243.html.

曾丽艳，王倩，孟现民，等.Ⅰ期临床试验生物样本的流程化管理[J].中华全科医学，2021，19（8）：1403-1407.

ZENG L Y，WANG Q，MENG X M，et al. Process management of biological samples in phase Ⅰ clinical trials[J]. Chin J Gen Pract，2021，19（8）：1403-1407.

谢江川，谢林利，曹丽亚，等.药物临床试验中常见方案偏离及改进措施[J].中国药房，2022，33（13）：1554-1558.

XIE J C，XIE L L，CAO L Y，et al. Common protocol deviations and improvement methods and precautions in drug clinical trials[J]. China Pharm，2022，33（13）：1554-1558.

谢江川，郭薇，谢林利，等.浅谈临床试验中药物管理要点及注意事项[J]. 中国药房，2019，30（21）：2894-2898.

XIE J C，GUO W，XIE L L，et al. Talking about the key points and notices of drug management in clinical trials[J]. China Pharm，2019，30（21）：2894-2898.

谢江川，李明红，谢林利，等. 重庆市药物临床试验研究者GCP参培现状调查[J]. 中国药业，2022，31（12）：6-9.

XIE J C，LI M H，XIE L L，et al. Investigation on current status of clinical trial researchers participating in GCP training in Chongqing[J]. China Pharm，2022，31（12）：6-9.

曾丽艳，王倩，柯晶，等.Ⅰ期临床试验生物样本管理的差错分析及应对措施探讨[J].中国药业，2022，31（1）：30-34.

ZENG L Y，WANG Q，KE J，et al. Error analysis and countermeasures of biological sample management in phase Ⅰ clinical trials[J]. China Pharm，2022，31（1）：30-34.

王佳楠，钱雪，李见明.药物临床试验数据核查工作及常见问题分析[J].中国新药杂志，2018，27（11）：1273-1276.

WANG J N，QIAN X，LI J M. Drug clinical trial data inspection and common problems analysis[J]. Chin J N Drugs，2018，27（11）：1273-1276.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

No data

Related Author

No data

Related Institution

No data

Address：8/F,129 Daping Main Street,Yuzhong District,Chongqing 400042,P.R.China
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰