美国批准后药物研究对新药利用影响的回顾性分析

Jean-Marc C. Haeusler
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引用次数: 0

摘要

批准后的研究可以为临床实践提供关键信息。然而,缺乏量化证据来证明其价值。本研究旨在评估批准后研究发表对药物使用的影响。这是对2002/2003年批准的美国药品销售数据的回顾性分析,并与上市后5年内在Pubmed上发表的时间进行比较。主要结果dSAMP是对利用率影响的替代度量,定义为发布前三个季度和随后三个季度的SAMP(实际销售减去线性回归预测)总和之间的差异。共收录15种产品764种出版物。平均dSAMP为1400万美元(95% CI 7.3-20.7;p = 0.00005), SAMP主要在发表后的第二和第三季度上升。dSAMP在0-2年为负,2-4年为中性,此后为正。方法的严谨性、地理分布和阳性或阴性结果对dSAMP的影响有限。总之,这是第一项证明批准后研究对药物利用影响的研究。一项已发表的研究导致平均销售额相对增加了1400万美元。有必要进一步研究以阐明利用与社会价值之间的联系。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Retrospective analysis of the impact of post-approval drug research on utilization of new medicines in the US
Post-approval research can provide critical information for clinical practice. However, quantitative evidence of its value is lacking. This study aimed to assess the impact of publications of post-approval studies on drug utilization. This was a retrospective analysis of US sales data of drugs approved in 2002/2003, compared with the timing of publications in Pubmed within 5 years of marketing. The primary outcome, dSAMP, was a surrogate measure for the impact on utilization, defined as the difference between the sums of SAMP (Sales Actuals Minus Predicted by linear regression) in the three quarters up to the publication and the three following quarters. Seven hundred and sixty-four publications of 15 products were included. Average dSAMP was US$ 14M (95% CI 7.3–20.7; p = 0.00005), with an increase in SAMP mainly in the second and third quarter after publication. dSAMP was negative for publications in years 0–2, neutral in years 2–4, and positive thereafter. Methodological rigor, geographic distribution, and positive or negative outcome only had limited impact on dSAMP. In conclusion, this was the first study demonstrating an impact of post-approval research on utilization of medicines. One published study led to a relative increase in average sales of US$ 14M. Further research is necessary to elucidate the link between utilization and societal value.
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