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澳大利亚癌症生物样本库队列中的质量与报告实践

Quality and reporting practices in an Australian cancer biobank cohort.

作者信息

Rush Amanda, Byrne Jennifer A

机构信息

Children's Cancer Research Unit, Kids Research Institute, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, 2145, NSW, Australia.

Children's Cancer Research Unit, Kids Research Institute, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, 2145, NSW, Australia; University of Sydney Discipline of Paediatrics and Child Health, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, 2145, NSW, Australia.

出版信息

Clin Biochem. 2016 Apr;49(6):492-497. doi: 10.1016/j.clinbiochem.2015.12.007. Epub 2015 Dec 17.

Abstract

OBJECTIVES

Inadequate research biospecimen quality may adversely impact research translation to clinical practice. Despite the development and endorsement of external quality assurance (QA) programs and biospecimen quality reporting tools, there has been little examination of relevant biobank practices.

DESIGN AND METHODS

An online survey was designed to describe the use and communication of QA and quality control (QC) measures within an Australian cancer biobank cohort (n=21), classified according to access policy. Survey questions examined the development and maintenance of Standard Operating Procedures (SOPs), other specific QA and biospecimen QC activities, and communication of biospecimen QC results to researchers.

RESULTS

Over three quarters of biobanks utilised regularly-reviewed, best-practice-referenced SOPs, and most biobanks undertook at least one QC activity. Whereas all open-access biobanks (n=11) utilised SOPs and undertook at least one QC activity, these practices were significantly less frequent in restricted-access biobanks (n=10). There were overall low rates of recording the SPREC code, with increased but incomplete recording of Tier 1 BRISQ data. Open-access biobanks were significantly more likely to provide biospecimen QC results to researchers, and to report receiving requests for QC results or additional sample data.

CONCLUSIONS

Improved resourcing and education may be required to boost current levels of QA and QC activities and reporting by cancer biobanks.

摘要

目的

研究生物样本质量不足可能会对研究成果转化为临床实践产生不利影响。尽管已经开发并认可了外部质量保证(QA)计划和生物样本质量报告工具,但对相关生物样本库实践的研究却很少。

设计与方法

设计了一项在线调查,以描述澳大利亚癌症生物样本库队列(n = 21)中QA和质量控制(QC)措施的使用和交流情况,并根据访问政策进行分类。调查问题涉及标准操作程序(SOP)的制定和维护、其他特定的QA和生物样本QC活动,以及将生物样本QC结果传达给研究人员的情况。

结果

超过四分之三的生物样本库使用了定期审查、参考最佳实践的SOP,并且大多数生物样本库至少开展了一项QC活动。所有开放获取的生物样本库(n = 11)都使用了SOP并至少开展了一项QC活动,而在限制访问的生物样本库(n = 10)中,这些做法的频率明显较低。记录SPREC代码的比例总体较低,一级BRISQ数据的记录有所增加但并不完整。开放获取的生物样本库更有可能向研究人员提供生物样本QC结果,并报告收到关于QC结果或额外样本数据的请求。

结论

可能需要增加资源投入和加强教育,以提高癌症生物样本库目前的QA和QC活动水平及报告情况。

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