The major role of clinicians in the discovery of off-label drug therapies
The major role of clinicians in the discovery of off-label drug therapies
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DOI：
10.1592/phco.26.3.323
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发表时间：
2006-03-01
期刊：
影响因子：
4.1
通讯作者：
von Hippel, E
中科院分区：
文献类型：
--
作者：
DeMonaco, HJ;Ali, A;von Hippel, E
Objective.确定临床医生在发现美国食品药品监督管理局（FDA）批准的处方药标签外使用中的作用。Micromedex Healthcare Series用于识别1998年FDA批准的新分子实体的新用途，通过MEDLINE访问1999年1月至2003年12月的文献，并通过美国专利商标局识别相关专利。对1998年批准的新分子实体药物的新治疗用途进行了调查，以获得随后5年的商业可用性。在这段期间内，当局以电脑搜寻一九九八年曾考虑及批准的29种新药的文献，结果发现有143项新申请。进行了文献和专利检索，以确定每个新申请的第一份报告。通过电子调查联系了开创性文章的作者，以确定他们是否实际上是新应用的发起人。如果是，则通过检查文章内容和作者调查来探索每个新应用是否是通过独立于制药公司或大学研究的临床实践发现的（现场发现），或者该发现是否是由制药公司或大学研究人员完成或参与的（中心发现）。我们样本中的143项药物治疗创新中有82项（57%）是由执业临床医生通过实地发现发现的。据我们所知，临床医生在发现新的标签外药物治疗中的主要作用以前没有记录或探索。我们认为这一发现具有重要的监管和卫生政策意义。
Objective. To determine the role of clinicians in the discovery of off-label use of prescription drugs approved by the United States Food and Drug Administration (FDA).Data Sources. Micromedex Healthcare Series was used to identify new uses of new molecular entities approved by the FDA in 1998, literature from January 1999-December 2003 was accessed through MEDLINE, and relevant patents were identified through the U.S. Patent and Trademark Office.Data Synthesis and Main Finding. A survey of new therapeutic uses for new molecular entity drugs approved in 1998 was conducted for the subsequent 5 years of commercial availability. During that period, 143 new applications were identified in a computerized search of the literature for the 29 new drugs considered and approved in 1998. Literature and patent searches were conducted to identify the first report of each new application. Authors of the seminal articles were contacted through an electronic survey to determine whether they were in fact the originators of the new applications. if they were, examination of article content and author surveys were used to explore if each new application was discovered through clinical practice that was independent of pharmaceutical company or university research (field discovery) or if the discovery was made by or with the involvement of pharmaceutical company or university researchers (central discovery). Eighty-two (57%) of the 143 drug therapy innovations in our sample were discovered by practicing clinicians through field discovery.Conclusion. To our knowledge, the major role of clinicians in the discovery of new, off-label drug therapies has not been previously documented or explored. We propose that this finding has important regulatory and health policy implications.