协作对临床开发时间的影响

Y. Park, Sang-Won Lee
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引用次数: 0

摘要

本研究调查了合作如何影响药物开发,包括新药开发领域的创新速度和生产力。2015年至2019年间,美国食品和药物管理局(FDA)批准的220种新药使用Clinicaltrials.gov数据库对每个临床阶段的持续时间进行了分析。与独立项目相比,合作药物开发项目的临床开发时间更长。最大的差异出现在第二阶段和第三阶段。小公司之间的合作比其他类型的合作需要更长的临床开发时间。这一结果提示,在制定新药开发策略时,应考虑到协同开发可能会减缓临床开发过程。
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Impact of Collaboration on Clinical Development Time
This research investigated how collaborations affect drug development, including innovation speed and productivity in the field of new drug development. Two-hundred and twenty new drugs approved by the Food and Drug Administration (FDA) between 2015 and 2019 were analyzed for the duration of each clinical phase using the Clinicaltrials.gov database. Collaborative drug development projects were associated with longer clinical development than independent projects. The largest differences were seen in phases 2 and 3. Collaborations between small firms were associated with longer clinical development times than other types of collaboration. This result suggests consideration should be given, when devising a new drug development strategy, to the fact that collaborative development can slow down the clinical development process.
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