Ghosh Rajesh, Kempf Dieter, Pufko Angela, Barrios Martinez Luisa Fernanda, Davis Chris M, Sethi Sundeep
Innovation, Chief Medical Office and Patient Safety, Novartis Pharma New Jersey, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Genentech, A Member of the Roche Group, South San Francisco, CA, USA.
Pharmaceut Med. 2020 Feb;34(1):7-18. doi: 10.1007/s40290-019-00320-0.
TransCelerate's Intelligent Automation Opportunities (IAO) in Pharmacovigilance initiative has been working to evaluate various pharmacovigilance processes to facilitate systematic innovation with intelligent automation across the entire area. The individual case safety report (ICSR) process was the first process selected for evaluation because of its resource-intensive nature, risk of errors, and operational inefficiencies.
TransCelerate's IAO in Pharmacovigilance initiative initially worked to articulate an end-to-end ICSR process that would generically apply to various pharmacovigilance organizations, despite organizational variations in specific ICSR process steps. This paper aims to address the need for a systematic review framework for automation of the ICSR process from the value, impact, perceived risk, and opportunity point of view.
The generic ICSR process, which starts with receipt of an adverse event report, was grouped into three process blocks: case intake, case processing, and case reporting. Each of these was then further detailed in individual process steps. A total of 19 TransCelerate member companies were invited to complete a survey designed to facilitate understanding of automation opportunities across the ICSR process. Heat maps of the current level of effort, expected benefit of automation, and perceived risk of automation were compiled from responses to identify intelligent automation opportunities for specific ICSR process steps. Relevant experts on the TransCelerate evaluation team analyzed and interpreted the anonymized and aggregated results.
In total, 15 TransCelerate member companies responded to the survey and indicated that ICSR process steps with current high effort, expected high automation benefit, low or manageable automation risk, and low levels of current automation present the best opportunities for future automation. Such steps include language translations, case verification, in-line quality control, prioritization/triage, data entry, alerts for cases of interest, workflow management, and monitoring. Some steps (e.g., submission) have been automated for a number of years and appear on the heat map as having low potential for further automation. The survey responses implied that, despite successful use of intelligent automation technologies in other areas, adoption within pharmacovigilance and the ICSR process in particular remains limited. The perceived high risk to patient safety is expected to decrease with additional successful applications in pharmacovigilance.
Our results highlight the areas of greatest opportunity for intelligent automation based on the potential benefits of applying intelligent automation and the perceived risks associated with each ICSR process step. Responding TransCelerate member companies already automate many steps to varying degrees. However, a significant opportunity remains for automation to penetrate further. Additionally, the pharmacovigilance industry culture needs to change in order to reduce the perceived risk of automation and to encourage a more progressive approach to intelligent automation. Increased automation is crucial to empower agile and efficient pharmacovigilance.
加速创新协作组织（TransCelerate）的药物警戒智能自动化机会（IAO）倡议一直在努力评估各种药物警戒流程，以促进在整个领域通过智能自动化进行系统创新。由于个体病例安全报告（ICSR）流程资源密集、存在错误风险且运营效率低下，因此它是首个被选定进行评估的流程。
加速创新协作组织的药物警戒IAO倡议最初致力于阐明一个适用于各种药物警戒组织的端到端ICSR流程，尽管各组织在特定ICSR流程步骤上存在差异。本文旨在从价值、影响、感知风险和机会的角度，满足对ICSR流程自动化进行系统审查框架的需求。
从收到不良事件报告开始的通用ICSR流程被分为三个流程模块：病例录入、病例处理和病例报告。然后，每个模块在各个流程步骤中进一步细化。总共邀请了19家加速创新协作组织成员公司完成一项调查，以促进对ICSR流程中自动化机会的理解。根据回复编制了当前工作量水平、自动化预期效益和自动化感知风险的热力图，以确定特定ICSR流程步骤的智能自动化机会。加速创新协作组织评估团队的相关专家对匿名汇总结果进行了分析和解读。
共有15家加速创新协作组织成员公司回复了调查，结果表明，当前工作量大、自动化预期效益高、自动化风险低或可控且当前自动化水平低的ICSR流程步骤，是未来自动化的最佳机会所在。这些步骤包括语言翻译、病例核实、在线质量控制、优先级划分/分流、数据录入、关注病例警报、工作流程管理和监测。一些步骤（如提交）已经自动化多年，在热力图上显示进一步自动化的潜力较低。调查回复表明，尽管智能自动化技术在其他领域得到了成功应用，但在药物警戒领域，尤其是ICSR流程中的采用仍然有限。随着药物警戒领域更多成功应用的出现，预计对患者安全的感知高风险将会降低。
我们的结果突出了基于应用智能自动化的潜在益处以及与每个ICSR流程步骤相关的感知风险，智能自动化机会最大的领域。参与回复的加速创新协作组织成员公司已经在不同程度上对许多步骤进行了自动化。然而，自动化进一步渗透仍有很大机会。此外，药物警戒行业文化需要改变，以降低对自动化的感知风险，并鼓励采用更进取的智能自动化方法。增加自动化对于实现敏捷高效的药物警戒至关重要。
