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药物临床试验中生物样本管理常见问题及措施建议
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| 篇名： | 药物临床试验中生物样本管理常见问题及措施建议 |
| TITLE： | Common problems and suggestions of biological sample management in drug clinical trials |
| 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. |
| 期刊： | 2024年第35卷第05期 |
| 作者： | 谢江川；谢林利；马攀；潘辛梅；曹丽亚；张馨；陈勇川 |
| AUTHORS： | XIE Jiangchuan，XIE Linli，MA Pan，PAN Xinmei，CAO Liya，ZHANG Xin，CHEN Yongchuan |
| 关键字： | 药物临床试验；生物样本；生物样本管理 |
| KEYWORDS： | drug clinical trials； biological sample； biological sample management |
| 阅读数： | 84 次 |
| 本月下载数： | 26 次 |
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