Incorporating clinical data held by national health product regulatory authorities into secondary analyses such as systematic reviews can help combat publication bias and selective outcome reporting, in turn, supporting more evidence-based decisions regarding the prescribing of drugs, biologics and vaccines. Owing to recent changes in Canadian law, Health Canada has begun to make clinical information—whether it has been previously published or not—publicly available through its ‘Public Release of Clinical Information’ (PRCI) online database. We provide guidance about how to access and use regulatory data obtained through the PRCI database for the purpose of conducting drug and biologic secondary analyses. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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如何使用加拿大卫生部的监管数据对新药、生物制剂和疫苗进行二次分析


将国家卫生产品监管机构掌握的临床数据纳入系统评价等二次分析，有助于消除发表偏见和选择性结果报告，进而支持有关药物、生物制剂和疫苗处方的更多循证决策。由于加拿大法律最近发生变化，加拿大卫生部已开始通过其“临床信息公开发布”(PRCI) 在线数据库公开临床信息（无论之前是否已发布）。我们提供有关如何访问和使用通过 PRCI 数据库获得的监管数据以进行药物和生物制品二次分析的指导。与研究相关的所有数据都包含在文章中或作为补充信息上传。