Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance
Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance
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DOI：
10.1007/s40264-018-0759-7
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发表时间：
2019-05-01
期刊：
影响因子：
4.2
通讯作者：
Dal Pan, Gerald J.
中科院分区：
文献类型：
--
作者：
Harinstein, Lisa;Kalra, Dipti;Dal Pan, Gerald J.
来自行业申办项目（如患者支持项目）的不良事件报告导致美国食品药品监督管理局不良事件报告系统数据库中的个体病例安全性报告数量增加。本研究旨在描述行业赞助项目和非行业赞助项目来源的个体病例安全性报告的特征，并比较其在安全性信号检测方面的有用性。在美国食品药品监督管理局产品批准日期至2017年第一季度期间，在美国食品药品监督管理局不良事件报告系统数据库中确定了6种药物和生物制品的个体病例安全性报告。然后比较行业申办项目和非行业申办项目个体病例安全性报告的随机子集，以确定报告者、结局、数据完整性和有用性的差异。通过手动审查叙述中关键信息的可用性（例如，与非行业赞助的项目报告相比，更多的行业赞助的项目报告与严重结局相关（51.4%对58.8%，p = 0.02），并且由消费者报告（35.5%对50.4%，p < 0.01）。行业赞助的计划报告倾向于包含比非行业赞助的计划报告更多的数据元素（即，年龄、性别、适应症），但不同产品的完整性不同。未发现非行业申办项目和行业申办项目个体病例安全性报告之间的有效性存在显著差异（30.6% vs. 28.5%，p = 0.42）。包含至少1起严重、未标记不良事件的有用报告仅占非行业申办项目和行业申办项目报告队列的4%和6.2%，我们的研究表明，从食品和药物管理局不良事件报告系统数据库中的行业赞助项目中获得的报告包含更多的数据元素，但与非行业相似，赞助程序报告关于信号检测中的“有用性”。
Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection.Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The 'usefulness' of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities).Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p = 0.02) and were reported by consumers (35.5% vs. 50.4%, p < 0.01). Industry-sponsored program reports tended to contain more data elements than non-industry-sponsored program reports (i.e., age, sex, indication for use), but completeness was variable across products. No significant difference in usefulness was identified between non-industry-sponsored program and industry-sponsored program individual case safety reports (30.6% vs. 28.5%, p = 0.42). Useful reports that contained at least one serious, unlabeled adverse event represented only 4% and 6.2% of the non-industry-sponsored program and industry-sponsored program report cohorts, respectively.Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to 'usefulness' in signal detection.