Identifying Actionability as a Key Factor for the Adoption of 'Intelligent' Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach.

INTRODUCTION Information technology (IT) plays an important role in the healthcare landscape via the increasing digitization of medical data and the use of modern computational paradigms such as machine learning (ML) and knowledge graphs (KGs). These 'intelligent' technical paradigms provide a new digital 'toolkit' supporting drug safety and healthcare processes, including 'active pharmacovigilance'. While these technical paradigms are promising, intelligent systems (ISs) are not yet widely adopted by pharmacovigilance (PV) stakeholders, namely the pharma industry, academia/research community, drug safety monitoring organizations, regulatory authorities, and healthcare institutions. The limitations obscuring the integration of ISs into PV activities are multifaceted, involving technical, legal and medical hurdles, and thus require further elucidation. OBJECTIVE We dissect the abovementioned limitations by describing the lessons learned during the design and implementation of the PVClinical platform, a web platform aiming to support the investigation of potential adverse drug reactions (ADRs), emphasizing the use of knowledge engineering (KE) as its main technical paradigm. RESULTS To this end, we elaborate on the related 'business processes' (i.e. operational processes) and 'user goals' identified as part of the PVClinical platform design process based on Design Thinking principles. We also elaborate on key challenges restricting the adoption of such ISs and their integration in the clinical setting and beyond. CONCLUSIONS We highlight the fact that beyond providing analytics and useful statistics to the end user, 'actionability' has emerged as the operational priority identified through the whole process. Furthermore, we focus on the needs for valid, reproducible, explainable and human-interpretable results, stressing the need to emphasize on usability.