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Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation
Therapeutic Innovation & Regulatory Science ( IF 1.5 ) Pub Date : 2020-05-29 , DOI: 10.1007/s43441-020-00167-7
Magdalena Bujar 1 , Neil McAuslane 1 , Patricia Connelly 1 , Stuart R Walker 1
Affiliation  

Background Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into a learning system. Nevertheless, such a correlation can only be achieved by documenting the expected outcome of a decision at the time it is made, enabling comparison of the expected outcome with the actual result. Methods Participants at an international workshop discussed how the documentation of decisions could be evolved as companies and agencies look to improve their knowledge base. Discussions were informed by a pre-workshop survey of pharmaceutical companies and regulatory agencies. Results Most survey participants from 12 companies (55% response rate) and 11 agencies (73% response) have a system in place to enable documentation of major decisions, however, systems are used primarily to document outcomes rather than the process, while information from documentation is not always used, and feedback loops are not in place. The majority of participants indicated that their organization currently documents most decision-making practices included in the proposed template. Workshop participants agreed that all major past decisions should be referenceable and suggested incentives to enable decisions to be referenced, and confirmed elements and characteristics of a decision-documentation template. Conclusions This survey and workshop identified the current landscape and gaps in the documentation of decision making and suggested revisions for a proposed documentation template. The use of technology to enable information extraction with support from artificial intelligence and future decision making was a recommendation highlighted by participants.

中文翻译:

制药公司和监管机构的质量决策实践:当前和建议的文档方法

背景 制药公司和监管机构努力将他们的决策与结果联系起来,以改进未来的决策并确保将获得的知识反馈到学习系统中。然而,这种相关性只能通过在做出决策时记录决策的预期结果来实现,从而能够将预期结果与实际结果进行比较。方法 国际研讨会的参与者讨论了如何在公司和机构寻求改进其知识库时改进决策文件。研讨会前对制药公司和监管机构的调查为讨论提供了信息。结果 来自 12 家公司(55% 的回应率)和 11 个机构(73% 的回应率)的大多数调查参与者都有一个系统来记录重大决策,但是,系统主要用于记录结果而不是过程,而来自文档并不总是使用,反馈循环也没有到位。大多数参与者表示,他们的组织目前记录了提议模板中包含的大多数决策实践。研讨会参与者一致认为,过去的所有重大决策都应该是可参考的,并提出了使决策能够被参考的激励措施,并确认了决策文档模板的要素和特征。结论 本次调查和研讨会确定了决策文件的当前格局和差距,并建议对拟议的文件模板进行修订。使用技术在人工智能和未来决策的支持下实现信息提取是与会者强调的一项建议。
更新日期:2020-05-29
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