Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance.

TransCelerate reports on the results of 2019, 2020, and 2021 member company (MC) surveys on the use of intelligent automation in pharmacovigilance processes. MCs increased the number and extent of implementation of intelligent automation solutions throughout Individual Case Safety Report (ICSR) processing, especially with rule-based automations such as robotic process automation, lookups, and workflows, moving from planning to piloting to implementation over the 3 survey years. Companies remain highly interested in other technologies such as machine learning (ML) and artificial intelligence, which can deliver a human-like interpretation of data and decision making rather than just automating tasks. Intelligent automation solutions are usually used in combination with more than one technology being used simultaneously for the same ICSR process step. Challenges to implementing intelligent automation solutions include finding/having appropriate training data for ML models and the need for harmonized regulatory guidance.

Automation Opportunities in Pharmacovigilance: An Industry Survey.

BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. 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. CONCLUSIONS: 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.